Alvotech is looking for a new member to join Pharmaceutical Sciences Quality. The department provides Quality and Compliance related support for multiple R&amp;D activities across Alvotech sites. Potential candidate for this role understands the need for, and application of phase appropriate control across the development lifecycle within R&amp;D, principles of method validations, Quality Management System (QMS) and cGMP.
Pharmaceutical Sciences (PharmSci) Quality (PSQ) is a function within R&amp;D focused with quality oversight on development and validation activities at Alvotech across the development lifecycle.

We offer a fun and challenging job in an international environment with diverse opportunities for professional development. If this exciting opportunity interests you, we invite you to explore further details on our website.

Alvotech er fjölþjóðlegt hátæknifyrirtæki í fremstu röð, þar sem yfir 1000 starfsmenn af um 64 þjóðernum vinna að því að móta framtíðina á sviði líftæknilyfja og auka aðgengi sjúklinga um allan heim að hágæða lyfjum. Margir af færustu vísindamönnum landsins starfa hjá fyrirtækinu. 

Við leyfum fjölbreytileika, forvitni og frumkvæði starfsfólks að njóta sín. Við bjóðum aðlaðandi starfsumhverfi í stöðugri mótun og ögrandi verkefni. Alvotech tryggir að jafnrétti kynjanna til launa og frama nái til allra starfsmanna, hérlendis jafnt sem erlendis. Við viljum laða að okkur færasta fólkið á hverju sviði, án tillits til uppruna eða kyns. Með þessum hætti getum við best þjónað hagsmunum sjúklinga og samstarfsaðilum okkar. 

Vertu með okkur í að bæta lífsgæði fólks og auka aðgengi að hagkvæmum líftæknilyfjum. 


1001-5000

Alvotech hf


Alvotech is looking for a new member to join Pharmaceutical Sciences Quality. The department provides Quality and Compliance related support for multiple R&amp;D activities across Alvotech sites. Potential candidate for this role understands the need for, and application of phase appropriate control across the development lifecycle within R&amp;D, principles of method validations, Quality Management System (QMS) and cGMP.

Pharmaceutical Sciences (PharmSci) Quality (PSQ) is a function within R&amp;D focused with quality oversight on development and validation activities at Alvotech across the development lifecycle.



We offer a fun and challenging job in an international environment with diverse opportunities for professional development. If this exciting opportunity interests you, we invite you to explore further details on our website.



Active

Principal/ Senior Specialist Pharmaceutical Sciences Quality – R&D Quality Generalist

Alvotech leitar a&eth; &aacute;hugas&ouml;mum og metna&eth;arfullum einstaklingi til a&eth; vinna me&eth; &ouml;flugu&nbsp;l&iacute;fv&iacute;sindateymi&nbsp;sem s&eacute;rh&aelig;fir sig &iacute;&nbsp;&thorn;r&oacute;un frumur&aelig;ktunar ferla&nbsp;til framlei&eth;slu &aacute; l&iacute;ft&aelig;knilyfjahli&eth;st&aelig;&eth;um.

Helstu verkefni:
<ul>
<li>Vinna &aacute; ranns&oacute;knarstofu og me&eth;h&ouml;ndlun &aacute; &yacute;msum t&aelig;kjum og b&uacute;na&eth;i sem tengjast r&aelig;ktun &aacute; erf&eth;abreyttum frumum og framlei&eth;slu &aacute; einstofna m&oacute;tefnum, &thorn;ar &aacute; me&eth;al r&aelig;ktunart&ouml;nkum &iacute; mismunandi st&aelig;r&eth;um.</li>
<li>Tilraunir, gagnas&ouml;fnun, mat, greining og sk&yacute;rsluger&eth;ir me&eth; megin markmi&eth; a&eth; &thorn;r&oacute;a skilvirkan frumur&aelig;ktunar feril fyrir framlei&eth;slu &aacute; l&iacute;ft&aelig;knilyfjum.</li>
</ul>
Vi&eth; bj&oacute;&eth;um upp &aacute; skemmtilegt og krefjandi starf &iacute; al&thorn;j&oacute;&eth;legu umhverfi &aacute;samt fj&ouml;lbreyttum t&aelig;kif&aelig;rum til starfs&thorn;r&oacute;unar. Ef &thorn;&uacute; hefur &aacute;huga &aacute; &thorn;essu spennandi t&aelig;kif&aelig;ri, hvetjum vi&eth; &thorn;ig til a&eth; kynna &thorn;&eacute;r &thorn;a&eth; betur h&eacute;r &aacute; heimas&iacute;&eth;u okkar. 
[English]

Alvotech is seeking a dedicated cell culture scientist to join our&nbsp;Upstream Process (USP) Research and Development (R&amp;D) team.&nbsp;As a scientist, you will play a crucial role in our USP team developing a small-scale bioreactor process for subsequent scale-up and transfer to a manufacturing environment for production of biosimilars.
Scope &amp; Responsibilities:
<ul>
<li>Mammalian cell culture at different USP stages spanning from shake flasks, rocker bioreactor, Ambr250 and up to 15L production bioreactors, finalized by cell clarification.</li>
<li>General lab management on daily basis and operational work with bioreactor systems and associated analytical instruments.</li>
<li>Experimental execution and data collection, evaluation and analysis for effective upstream process development, optimization and characterization.</li>
<li>Technical report writing to feed into successful technology transfer to pilot/manufacturing scale and support of regulatory submission. </li>
</ul>
We offer a fun and challenging job in an international environment with diverse opportunities for professional development. If this exciting opportunity interests you, we invite you to explore further details on our website.

What we offer:
<ul>
<li>An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.</li>
<li>The chance to be a part of a global and fast-growing company.</li>
<li>An international work culture that encourages diversity, collaboration and inclusion.</li>
<li>Positive, flexible, and innovative work environment.</li>
<li>Support for personal growth and internal career development.</li>
<li>Company social events and milestone celebrations.</li>
<li>Excellent in-house canteen and coffee house.</li>
<li>Exercise and wellbeing support for full-time employees.</li>
<li>On-site shower facility.</li>
<li>Transportation grant towards eco-friendly modes of travel for full-time employees.</li>
<li>Internet at home for full-time employees.</li>
</ul>
Why Alvotech
At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We&rsquo;re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.
True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let&rsquo;s create a healthier world together, through affordable biologic medicines.


Alvotech leitar að áhugasömum og metnaðarfullum einstaklingi til að vinna með öflugu
lífvísindateymi
sem sérhæfir sig í
þróun frumuræktunar ferla
til framleiðslu á líftæknilyfjahliðstæðum.



Helstu verkefni:


 - Vinna á rannsóknarstofu og meðhöndlun á ýmsum tækjum og búnaði sem tengjast ræktun á erfðabreyttum frumum og framleiðslu á einstofna mótefnum, þar á meðal ræktunartönkum í mismunandi stærðum.

 - Tilraunir, gagnasöfnun, mat, greining og skýrslugerðir með megin markmið að þróa skilvirkan frumuræktunar feril fyrir framleiðslu á líftæknilyfjum.


Við bjóðum upp á skemmtilegt og krefjandi starf í alþjóðlegu umhverfi ásamt fjölbreyttum tækifærum til starfsþróunar. Ef þú hefur áhuga á þessu spennandi tækifæri, hvetjum við þig til að kynna þér það betur hér á heimasíðu okkar.


[English]



Alvotech is seeking a dedicated cell culture scientist to join our
Upstream Process (USP) Research and Development (R&amp;D) team.
As a scientist, you will play a crucial role in our USP team developing a small-scale bioreactor process for subsequent scale-up and transfer to a manufacturing environment for production of biosimilars.

Scope &amp; Responsibilities:


 - Mammalian cell culture at different USP stages spanning from shake flasks, rocker bioreactor, Ambr250 and up to 15L production bioreactors, finalized by cell clarification.

 - General lab management on daily basis and operational work with bioreactor systems and associated analytical instruments.

 - Experimental execution and data collection, evaluation and analysis for effective upstream process development, optimization and characterization.

 - Technical report writing to feed into successful technology transfer to pilot/manufacturing scale and support of regulatory submission.




We offer a fun and challenging job in an international environment with diverse opportunities for professional development. If this exciting opportunity interests you, we invite you to explore further details on our website.



What we offer:


 - An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.

 - The chance to be a part of a global and fast-growing company.

 - An international work culture that encourages diversity, collaboration and inclusion.

 - Positive, flexible, and innovative work environment.

 - Support for personal growth and internal career development.

 - Company social events and milestone celebrations.

 - Excellent in-house canteen and coffee house.

 - Exercise and wellbeing support for full-time employees.

 - On-site shower facility.

 - Transportation grant towards eco-friendly modes of travel for full-time employees.

 - Internet at home for full-time employees.


Why Alvotech

At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.

True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.

Sérfræðingur / Scientist - Upstream Process Development (R&D)

Alvotech &iacute; Reykjav&iacute;k leitar eftir &aacute;hugas&ouml;mum einstaklingum til a&eth; ganga til li&eth;s vi&eth; framlei&eth;sluteymi&eth; &iacute; st&ouml;&eth;u hreinsit&aelig;knis.
Sem hreinsit&aelig;knir munt &thorn;&uacute; gegna mikilv&aelig;gu hlutverki vi&eth; a&eth; vi&eth;halda hreinl&aelig;ti &iacute; framlei&eth;slunni hj&aacute; okkur. Hj&aacute; Alvotech st&ouml;rfum vi&eth; &iacute; reglubundnu umhverfi sem krefst umfangsmikillar &thorn;j&aacute;lfunar. Vi&eth; leitum a&eth; einstaklingum sem hafa auga fyrir sm&aacute;atri&eth;um, g&oacute;&eth;a enskukunn&aacute;ttu og reynslu af &thorn;v&iacute; a&eth; starfa &iacute; teymi.
Ef &thorn;&uacute; b&yacute;r&eth; yfir &thorn;essum eiginleikum &thorn;&aacute; hvetjum vi&eth; &thorn;ig eindregi&eth; til &thorn;ess a&eth; s&aelig;kja um.
Vinsamlegast athugi&eth; a&eth; vinnut&iacute;mi fyrir &thorn;essa st&ouml;&eth;u er fr&aacute; 06:00-14:00, en mun f&aelig;rast yfir &iacute; dagvakt (06:00 - 14:00) / kv&ouml;ldvakt (14:00 - 22:00), me&eth; vaktaskiptum.

[English]

Alvotech in Reykjavik is seeking dedicated individuals to join the Manufacturing Team as a Facility Cleaning Specialist.

As a Facility Cleaning Specialist, you will play a crucial role in maintaining the cleanliness and integrity of our state-of-the-art facilities. At Alvotech, we operate in a highly regulated environment, which requires extensive training. We are dedicated to empowering our employees by providing comprehensive support, mentoring, and guidance throughout their journey with us. We are looking for individuals with a keen eye for detail, exceptional English language proficiency, and the ability to effectively communicate and collaborate within a team.

If you possess these skills and bring a positive attitude along with adaptability, we invite you to seize this opportunity and apply now.

Please note that the working hours for this position are currently from 06:00-14:00, but will be moving to day (06:00 - 14:00)/evening (14:00 - 22:00) rotating shift work (weekend work included).

Scope and Responsibility
<ul>
<li>Responsible for the cleaning of current Good Manufacturing Practices (cGMP) controlled/classified areas.</li>
<li>Responsible for stocking material for the Manufacturing areas.</li>
<li>Responsible for taking care of waste from Manufacturing areas.</li>
<li>Responsible for ensuring that manufacturing areas are orderly.</li>
</ul>

Job Requirements
<ul>
<li>Excellent command of the English language, both verbal and written, with the ability to communicate fluently and comprehend written instructions.</li>
<li>Demonstrate a positive attitude, strong teamwork skills, and the ability to collaborate effectively with colleagues.</li>
<li>Prior cleaning experience is a plus.</li>
</ul>

What we offer
<ul>
<li>An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.</li>
<li>The chance to be a part of a global and fast-growing company.</li>
<li>An international work culture that encourages diversity, collaboration, and inclusion.</li>
<li>Positive, flexible, and innovative work environment.</li>
<li>Support for personal growth and internal career development.</li>
<li>Company social events and milestone celebrations.</li>
<li>Excellent in-house canteen and coffee house.</li>
<li>Exercise and well-being support for full-time employees.</li>
<li>On-site shower facility.</li>
<li>Transportation grant towards eco-friendly modes of travel for full-time employees.</li>
<li>Internet at home for full-time employees.</li>
</ul>

Why Alvotech

At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We&rsquo;re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.

True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let&rsquo;s create a healthier world together, through affordable biologic medicines.


Alvotech í Reykjavík leitar eftir áhugasömum einstaklingum til að ganga til liðs við framleiðsluteymið í stöðu hreinsitæknis.

Sem hreinsitæknir munt þú gegna mikilvægu hlutverki við að viðhalda hreinlæti í framleiðslunni hjá okkur. Hjá Alvotech störfum við í reglubundnu umhverfi sem krefst umfangsmikillar þjálfunar. Við leitum að einstaklingum sem hafa auga fyrir smáatriðum, góða enskukunnáttu og reynslu af því að starfa í teymi.

Ef þú býrð yfir þessum eiginleikum þá hvetjum við þig eindregið til þess að sækja um.

Vinsamlegast athugið að vinnutími fyrir þessa stöðu er frá 06:00-14:00, en mun færast yfir í dagvakt (06:00 - 14:00) / kvöldvakt (14:00 - 22:00), með vaktaskiptum.



[English]



Alvotech in Reykjavik is seeking dedicated individuals to join the Manufacturing Team as a Facility Cleaning Specialist.



As a Facility Cleaning Specialist, you will play a crucial role in maintaining the cleanliness and integrity of our state-of-the-art facilities. At Alvotech, we operate in a highly regulated environment, which requires extensive training. We are dedicated to empowering our employees by providing comprehensive support, mentoring, and guidance throughout their journey with us. We are looking for individuals with a keen eye for detail, exceptional English language proficiency, and the ability to effectively communicate and collaborate within a team.



If you possess these skills and bring a positive attitude along with adaptability, we invite you to seize this opportunity and apply now.



Please note that the working hours for this position are currently from 06:00-14:00, but will be moving to day (06:00 - 14:00)/evening (14:00 - 22:00) rotating shift work (weekend work included).



Scope and Responsibility


 - Responsible for the cleaning of current Good Manufacturing Practices (cGMP) controlled/classified areas.

 - Responsible for stocking material for the Manufacturing areas.

 - Responsible for taking care of waste from Manufacturing areas.

 - Responsible for ensuring that manufacturing areas are orderly.




Job Requirements


 - Excellent command of the English language, both verbal and written, with the ability to communicate fluently and comprehend written instructions.

 - Demonstrate a positive attitude, strong teamwork skills, and the ability to collaborate effectively with colleagues.

 - Prior cleaning experience is a plus.




What we offer


 - An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.

 - The chance to be a part of a global and fast-growing company.

 - An international work culture that encourages diversity, collaboration, and inclusion.

 - Positive, flexible, and innovative work environment.

 - Support for personal growth and internal career development.

 - Company social events and milestone celebrations.

 - Excellent in-house canteen and coffee house.

 - Exercise and well-being support for full-time employees.

 - On-site shower facility.

 - Transportation grant towards eco-friendly modes of travel for full-time employees.

 - Internet at home for full-time employees.




Why Alvotech



At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.



True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.

Hreinsitæknir / Manufacturing Facility Cleaning Specialist

Gakktu til li&eth;s vi&eth; framlei&eth;sluteymi&eth; hj&aacute; Alvotech &iacute; Reykjav&iacute;k! Vi&eth; leitum a&eth; einstaklingum me&eth; j&aacute;kv&aelig;tt vi&eth;horf, g&oacute;&eth;a a&eth;l&ouml;gunarh&aelig;fni og getu til a&eth; takast &aacute; vi&eth; &aacute;skoranir.&nbsp;Vinna &aacute; dag- og kv&ouml;ldv&ouml;ktum er nau&eth;synleg. 
&THORN;essi sta&eth;a b&yacute;&eth;ur upp &aacute; hagn&yacute;ta reynslu &iacute; al&thorn;j&oacute;&eth;legu umhverfi &aacute;samt fj&ouml;lbreyttum t&aelig;kif&aelig;rum til starfs&thorn;r&oacute;unar! 
Helstu verkefni og &aacute;byrg&eth;: 
<ul>
<li>Flutningur framlei&eth;sluefna fr&aacute; v&ouml;ruh&uacute;si yfir &iacute; Class D sv&aelig;&eth;i.</li>
<li>Fylla &aacute; og vi&eth;halda Kanban efnaherbergjum &aacute; DSM1 og DSM2 sv&aelig;&eth;um.</li>
<li>Tryggja a&eth; framlei&eth;slu&aacute;&aelig;tlun s&eacute; uppf&aelig;r&eth;.</li>
<li>Sty&eth;ja vi&eth; heildarframlei&eth;slu og tryggja a&eth; &aacute;&aelig;tlanager&eth; s&eacute; r&eacute;tt framkv&aelig;md. </li>
</ul>
Menntunar- og h&aelig;fniskr&ouml;fur: 
<ul>
<li>Grunn&thorn;ekking &aacute; vi&eth;eigandi ferlum og t&aelig;kni.</li>
<li>Fram&uacute;rskarandi samskiptah&aelig;fileikar.</li>
<li>Geta til a&eth; vinna &iacute; teymi.</li>
<li>Stundv&iacute;si og &aacute;rei&eth;anleiki.</li>
<li>Sveigjanleiki og g&oacute;&eth; a&eth;l&ouml;gunarh&aelig;fni. </li>
</ul>
[English] 
Join the production team at Alvotech in Reykjav&iacute;k!
We are looking for individuals with a positive attitude, strong adaptability, and the ability to tackle challenges.&nbsp;Working day and evening shifts is required.

This position offers hands-on experience in an international environment along with diverse opportunities for professional development! 
Key Responsibilities: 
<ul>
<li>Material transfer of process materials from Warehouse to Class D area.</li>
<li>To stock up and maintain Kanban material rooms in DSM1 and DSM2 areas.</li>
<li>Ensure to update planning related activities.</li>
<li>To support overall manufacturing &amp; ensure planning is performed properly. </li>
</ul>
Qualifications: 
<ul>
<li>Basic technical or administrative knowledge or relevant process knowledge.</li>
<li>Adhere to the company etiquette in all matters of behavior and manners.</li>
<li>Excellent communication skills.</li>
<li>Strong work ethic and proven ability to collaborate effectively in team</li>
<li>Punctual and reliable.</li>
<li>Flexible/adaptable. </li>
</ul>
What we offer: 
<ul>
<li>An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.</li>
<li>The chance to be a part of a global and fast-growing company.</li>
<li>An international work culture that encourages diversity, collaboration and inclusion.</li>
<li>Positive, flexible, and innovative work environment.</li>
<li>Support for personal growth and internal career development.</li>
<li>Company social events and milestone celebrations.</li>
<li>Excellent in-house canteen and coffee house.</li>
<li>Exercise and wellbeing support for full-time employees.</li>
<li>On-site shower facility.</li>
<li>Transportation grant towards eco-friendly modes of travel for full-time employees.</li>
<li>Internet at home for full-time employees. </li>
</ul>
Why Alvotech 
At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We&rsquo;re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.

True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let&rsquo;s create a healthier world together, through affordable biologic medicines.


Gakktu til liðs við framleiðsluteymið hjá Alvotech í Reykjavík! Við leitum að einstaklingum með jákvætt viðhorf, góða aðlögunarhæfni og getu til að takast á við áskoranir.
Vinna á dag- og kvöldvöktum er nauðsynleg.



Þessi staða býður upp á hagnýta reynslu í alþjóðlegu umhverfi ásamt fjölbreyttum tækifærum til starfsþróunar!



Helstu verkefni og ábyrgð:




 - Flutningur framleiðsluefna frá vöruhúsi yfir í Class D svæði.

 - Fylla á og viðhalda Kanban efnaherbergjum á DSM1 og DSM2 svæðum.

 - Tryggja að framleiðsluáætlun sé uppfærð.

 - Styðja við heildarframleiðslu og tryggja að áætlanagerð sé rétt framkvæmd.




Menntunar- og hæfniskröfur:




 - Grunnþekking á viðeigandi ferlum og tækni.

 - Framúrskarandi samskiptahæfileikar.

 - Geta til að vinna í teymi.

 - Stundvísi og áreiðanleiki.

 - Sveigjanleiki og góð aðlögunarhæfni.




[English]



Join the production team at Alvotech in Reykjavík!

We are looking for individuals with a positive attitude, strong adaptability, and the ability to tackle challenges.
Working day and evening shifts is required.



This position offers hands-on experience in an international environment along with diverse opportunities for professional development!



Key Responsibilities:




 - Material transfer of process materials from Warehouse to Class D area.

 - To stock up and maintain Kanban material rooms in DSM1 and DSM2 areas.

 - Ensure to update planning related activities.

 - To support overall manufacturing &amp; ensure planning is performed properly.




Qualifications:




 - Basic technical or administrative knowledge or relevant process knowledge.

 - Adhere to the company etiquette in all matters of behavior and manners.

 - Excellent communication skills.

 - Strong work ethic and proven ability to collaborate effectively in team

 - Punctual and reliable.

 - Flexible/adaptable.




What we offer:




 - An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.

 - The chance to be a part of a global and fast-growing company.

 - An international work culture that encourages diversity, collaboration and inclusion.

 - Positive, flexible, and innovative work environment.

 - Support for personal growth and internal career development.

 - Company social events and milestone celebrations.

 - Excellent in-house canteen and coffee house.

 - Exercise and wellbeing support for full-time employees.

 - On-site shower facility.

 - Transportation grant towards eco-friendly modes of travel for full-time employees.

 - Internet at home for full-time employees.




Why Alvotech



At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.



True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.

Framleiðslutæknir / Manufacturing Technologist

Vi&eth; leitum a&eth; metna&eth;arfullum og reyndum v&iacute;sindamanni til a&eth; ganga til li&eth;s vi&eth; n&yacute;stofna&eth; gildingarteymi innan &thorn;r&oacute;unardeildar Alvotech (ARD). &THORN;etta er einstakt t&aelig;kif&aelig;ri til a&eth; leggja sitt af m&ouml;rkum vi&eth; &thorn;r&oacute;un l&iacute;fsb&aelig;tandi me&eth;fer&eth;a &iacute; kraftmiklu og samstilltu starfsumhverfi.

Sem v&iacute;sindama&eth;ur &iacute; gildingarteyminu munt &thorn;&uacute; gegna lykilhlutverki &iacute; a&eth; tryggja &aacute;rei&eth;anleika og reglufylgni a&eth;fer&eth;a sem nota&eth;ar eru &iacute; &thorn;r&oacute;unarverkefnum Alvotech &aacute; svi&eth;i l&iacute;fvirkra samheitalyfja. &THORN;&uacute; munt taka virkan &thorn;&aacute;tt &iacute; &ouml;llum stigum a&eth;fer&eth;agildinga, &thorn;ar &aacute; me&eth;al vi&eth; ger&eth;, yfirfer&eth; og sam&thorn;ykkt verkferla og sk&yacute;rslna, og vinna n&aacute;i&eth; me&eth; &thorn;verfaglegum teymum &aacute; bor&eth; vi&eth; g&aelig;&eth;aeftirlit (QC) og g&aelig;&eth;atryggingu (QA) til a&eth; sty&eth;ja vi&eth; flutning a&eth;fer&eth;a milli deilda og tryggja a&eth; al&thorn;j&oacute;&eth;legum g&aelig;&eth;ast&ouml;&eth;lum s&eacute; fylgt.

Starf &thorn;itt mun sty&eth;ja vi&eth; markmi&eth; Alvotech um a&eth; auka a&eth;gengi sj&uacute;klinga um allan heim a&eth; h&aacute;g&aelig;&eth;a l&iacute;ft&aelig;knilyfjahli&eth;st&aelig;&eth;um, l&aelig;kka lyfjaver&eth; og b&aelig;ta l&iacute;fsg&aelig;&eth;i &thorn;eirra.

Vi&eth; bj&oacute;&eth;um upp &aacute; skemmtilegt og krefjandi starf &iacute; al&thorn;j&oacute;&eth;legu umhverfi &aacute;samt fj&ouml;lbreyttum t&aelig;kif&aelig;rum til starfs&thorn;r&oacute;unar. Ef &thorn;&uacute; hefur &aacute;huga &aacute; &thorn;essu spennandi t&aelig;kif&aelig;ri, hvetjum vi&eth; &thorn;ig til a&eth; kynna &thorn;&eacute;r &thorn;a&eth; betur h&eacute;r &aacute; heimas&iacute;&eth;u okkar.&nbsp;


[English]
We are seeking a dedicated and experienced Senior Scientist to join our newly formed Validation Team within the Analytical Research and Development (ARD) division. This is a unique opportunity to contribute to the development of life-changing therapies in a dynamic and collaborative environment.

As a Senior Scientist in the Validation Team, you will play a key role in ensuring the robustness, reliability, and regulatory compliance of analytical methods used across Alvotech&rsquo;s biosimilar development programs. You will be actively involved in multiple stages of validation activities, including protocol and report write, review and approval, and will collaborate closely with cross-functional teams such as Quality Control (QC) and Quality Assurance (QA) to support method handovers and ensure high standards of documentation and compliance.

Your work will directly support Alvotech&rsquo;s mission to deliver safe, effective, and affordable biologic medicines to patients worldwide.

We offer a fun and challenging job in an international environment with diverse opportunities for professional development. If this exciting opportunity interests you, we invite you to explore further details on our website.

What we offer:
<ul>
<li>An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.</li>
<li>The chance to be a part of a global and fast-growing company.</li>
<li>An international work culture that encourages diversity, collaboration and inclusion.</li>
<li>Positive, flexible, and innovative work environment.</li>
<li>Support for personal growth and internal career development.</li>
<li>Company social events and milestone celebrations.</li>
<li>Excellent in-house canteen and coffee house.</li>
<li>Exercise and wellbeing support for full-time employees.</li>
<li>On-site shower facility.</li>
<li>Transportation grant towards eco-friendly modes of travel for full-time employees.</li>
<li>Internet at home for full-time employees.</li>
</ul>

Why Alvotech

At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We&rsquo;re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.

True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let&rsquo;s create a healthier world together, through affordable biologic medicines.


Við leitum að metnaðarfullum og reyndum vísindamanni til að ganga til liðs við nýstofnað gildingarteymi innan þróunardeildar Alvotech (ARD). Þetta er einstakt tækifæri til að leggja sitt af mörkum við þróun lífsbætandi meðferða í kraftmiklu og samstilltu starfsumhverfi.



Sem vísindamaður í gildingarteyminu munt þú gegna lykilhlutverki í að tryggja áreiðanleika og reglufylgni aðferða sem notaðar eru í þróunarverkefnum Alvotech á sviði lífvirkra samheitalyfja. Þú munt taka virkan þátt í öllum stigum aðferðagildinga, þar á meðal við gerð, yfirferð og samþykkt verkferla og skýrslna, og vinna náið með þverfaglegum teymum á borð við gæðaeftirlit (QC) og gæðatryggingu (QA) til að styðja við flutning aðferða milli deilda og tryggja að alþjóðlegum gæðastöðlum sé fylgt.



Starf þitt mun styðja við markmið Alvotech um að auka aðgengi sjúklinga um allan heim að hágæða líftæknilyfjahliðstæðum, lækka lyfjaverð og bæta lífsgæði þeirra.



Við bjóðum upp á skemmtilegt og krefjandi starf í alþjóðlegu umhverfi ásamt fjölbreyttum tækifærum til starfsþróunar. Ef þú hefur áhuga á þessu spennandi tækifæri, hvetjum við þig til að kynna þér það betur hér á heimasíðu okkar.






[English]

We are seeking a dedicated and experienced Senior Scientist to join our newly formed Validation Team within the Analytical Research and Development (ARD) division. This is a unique opportunity to contribute to the development of life-changing therapies in a dynamic and collaborative environment.



As a Senior Scientist in the Validation Team, you will play a key role in ensuring the robustness, reliability, and regulatory compliance of analytical methods used across Alvotech’s biosimilar development programs. You will be actively involved in multiple stages of validation activities, including protocol and report write, review and approval, and will collaborate closely with cross-functional teams such as Quality Control (QC) and Quality Assurance (QA) to support method handovers and ensure high standards of documentation and compliance.



Your work will directly support Alvotech’s mission to deliver safe, effective, and affordable biologic medicines to patients worldwide.



We offer a fun and challenging job in an international environment with diverse opportunities for professional development. If this exciting opportunity interests you, we invite you to explore further details on our website.



What we offer:


 - An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.

 - The chance to be a part of a global and fast-growing company.

 - An international work culture that encourages diversity, collaboration and inclusion.

 - Positive, flexible, and innovative work environment.

 - Support for personal growth and internal career development.

 - Company social events and milestone celebrations.

 - Excellent in-house canteen and coffee house.

 - Exercise and wellbeing support for full-time employees.

 - On-site shower facility.

 - Transportation grant towards eco-friendly modes of travel for full-time employees.

 - Internet at home for full-time employees.




Why Alvotech



At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.



True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.

Reynslumikill sérfræðingur / Senior Scientist - Validation Team (ARD)

Alvotech leitar a&eth; frams&yacute;num og reynslumiklum lei&eth;toga til a&eth; st&yacute;ra fj&ouml;lbreyttum t&aelig;kni- og verkfr&aelig;&eth;iteymum og m&oacute;ta stefnu sem sty&eth;ur vi&eth; langt&iacute;mamarkmi&eth; fyrirt&aelig;kisins &iacute; vexti og n&yacute;sk&ouml;pun. Starfi&eth; felur &iacute; s&eacute;r yfirumsj&oacute;n yfir deildir &thorn;vert &aacute; t&aelig;kni- og verkfr&aelig;&eth;isvi&eth;i. Ef &thorn;&uacute; hefur mikla t&aelig;knilega &thorn;ekkingu, sterka lei&eth;togah&aelig;fileika og reynslu af GMP-umhverfi, &thorn;&aacute; er &thorn;etta t&aelig;kif&aelig;ri&eth; fyrir &thorn;ig til a&eth; hafa raunveruleg &aacute;hrif &aacute; framt&iacute;&eth; l&iacute;ft&aelig;knilyfja.

Helstu verkefni
<ul data-offset-key="7ib0-0-0">
<li data-block="true" data-editor="1i7dq" data-offset-key="7ib0-0-0">Lei&eth;a deildir &thorn;vert &aacute; t&aelig;kni- og verkfr&aelig;&eth;isvi&eth;.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="4l2ek-0-0">Tryggja reglufylgni og &ouml;ryggi &iacute; samr&aelig;mi vi&eth; GMP og ISO.</li>
<li data-block="true" data-editor="boils" data-offset-key="20hch-0-0">Lei&eth;a n&yacute;sk&ouml;pun, stefnum&oacute;tun og umb&aelig;tur &iacute; t&aelig;kni og ferlum.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="enisf-0-0">Hafa umsj&oacute;n me&eth; ger&eth; og eftirfylgni fj&aacute;rhags&aacute;&aelig;tlana</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="1u8p9-0-0">Samskipti vi&eth; innri og ytri hagsmunaa&eth;ila.</li>
</ul>
 H&aelig;fniskr&ouml;fur
<ul data-offset-key="4e6nm-0-0">
<li data-block="true" data-editor="1i7dq" data-offset-key="4e6nm-0-0">Meistaragr&aacute;&eth;a &iacute; verkfr&aelig;&eth;i e&eth;a skyldum greinum.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="963fq-0-0">10+ &aacute;ra reynsla &iacute; lyfjai&eth;na&eth;i e&eth;a l&iacute;ft&aelig;kni.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="fmdj0-0-0">Lei&eth;togah&aelig;fni og reynsla af &thorn;v&iacute; a&eth; lei&eth;a umfangsmikil verkefni.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="7n5kc-0-0">Yfirgripsmikil &thorn;ekking &aacute; GMP og verkferlum &iacute; lyfjaframlei&eth;slu.</li>
</ul>
 [English] Alvotech is a global biopharmaceutical company dedicated to the development and manufacture of high-quality biosimilar medicines. We are seeking a visionary and experienced Head of Engineering to lead our multidisciplinary engineering teams and drive strategic initiatives that support our long-term growth and innovation goals. 
Key Responsibilities:
<ul data-offset-key="7qvls-0-0">
<li data-block="true" data-editor="fi8lk" data-offset-key="7qvls-0-0">Develop and implement engineering strategies aligned with Alvotech&rsquo;s long-term objectives.</li>
<li data-block="true" data-editor="fi8lk" data-offset-key="6v8lg-0-0">Make critical decisions in engineering to ensure sustainability and regulatory compliance.</li>
<li data-block="true" data-editor="fi8lk" data-offset-key="fssrd-0-0">Oversee departments including Maintenance, Calibration, Facility Management, Commissioning &amp; Qualification, and Process Automation.</li>
<li data-block="true" data-editor="fi8lk" data-offset-key="2jngv-0-0">Promote collaboration and operational excellence across all engineering functions.</li>
</ul>
 Role-Specific Responsibilities
<ul data-offset-key="6a0po-0-0">
<li data-block="true" data-editor="fi8lk" data-offset-key="6a0po-0-0">Oversee and coordinate technology installations to support operational and business needs.</li>
<li data-block="true" data-editor="fi8lk" data-offset-key="9tiof-0-0">Ensure compliance with GMP, ISO, and other regulatory standards.</li>
<li data-block="true" data-editor="fi8lk" data-offset-key="3qqed-0-0">Drive process optimization and technological advancement.</li>
<li data-block="true" data-editor="fi8lk" data-offset-key="eac5o-0-0">Manage stakeholder communications and regulatory interactions.</li>
<li data-block="true" data-editor="fi8lk" data-offset-key="d537-0-0">Oversee budget preparation, tracking, and cost optimization.</li>
<li data-block="true" data-editor="fi8lk" data-offset-key="9rsf-0-0">Foster a culture of growth, learning, and high performance within the engineering team.</li>
<li data-block="true" data-editor="fi8lk" data-offset-key="67vuk-0-0">10+ years of relevant experience in pharmaceutical or biotechnology industries.</li>
<li data-block="true" data-editor="fi8lk" data-offset-key="9vcn9-0-0">Proven track record in managing large-scale engineering projects and cross-functional teams.</li>
<li data-block="true" data-editor="fi8lk" data-offset-key="elfve-0-0">Strong background in GMP-compliant environments.</li>
</ul>
 Skills &amp; Competencies:
<ul data-offset-key="483d9-0-0">
<li data-block="true" data-editor="1i7dq" data-offset-key="483d9-0-0">Deep technical expertise in engineering and regulatory standards.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="cid5u-0-0">Exceptional leadership, strategic thinking, and problem-solving abilities.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="crt66-0-0">Strong financial acumen and project management skills.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="7j9p2-0-0">Excellent communication and stakeholder management capabilities.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="ai246-0-0">Adaptability to VUCA (Volatility, Uncertainty, Complexity, Ambiguity) environments.</li>
</ul>
 Certifications (Preferred):
<ul data-offset-key="3f1su-0-0">
<li data-block="true" data-editor="1i7dq" data-offset-key="3f1su-0-0">PMP or equivalent project management certification.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="19asu-0-0">Six Sigma, Lean, or other quality management certifications.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="6m34q-0-0">Leadership development and coaching training.</li>
</ul>
 Qualifications:
<ul data-offset-key="uut2-0-0">
<li data-block="true" data-editor="1i7dq" data-offset-key="uut2-0-0">Master&rsquo;s degree in Engineering (Chemical, Mechanical, Biotechnology, Pharmacy, or related field).</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="1pcbk-0-0">10+ years of relevant experience in pharmaceutical or biotechnology industries.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="46lvq-0-0">Proven track record in managing large-scale engineering projects and cross-functional teams.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="8p3g1-0-0">Strong background in GMP-compliant environments.</li>
</ul>
 What we offer:
<ul data-offset-key="8t5i-0-0">
<li data-block="true" data-editor="1i7dq" data-offset-key="8t5i-0-0">An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="5n1cs-0-0">The chance to be a part of a global and fast-growing company.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="e9fgh-0-0">An international work culture that encourages diversity, collaboration and inclusion.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="ck8v8-0-0">Positive, flexible, and innovative work environment.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="bu7u7-0-0">Support for personal growth and internal career development.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="bgg6o-0-0">Company social events and milestone celebrations.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="7t1n2-0-0">Excellent in-house canteen and coffee house.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="c675s-0-0">Exercise and wellbeing support for full-time employees.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="3kbcd-0-0">On-site shower facility.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="8mgng-0-0">Transportation grant towards eco-friendly modes of travel for full-time employees.</li>
<li data-block="true" data-editor="1i7dq" data-offset-key="eelok-0-0">Internet at home for full-time employees.</li>
</ul>
 Why Alvotech At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We&rsquo;re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment. True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let&rsquo;s create a healthier world together, through affordable biologic medicines.


Alvotech leitar að framsýnum og reynslumiklum leiðtoga til að stýra fjölbreyttum tækni- og verkfræðiteymum og móta stefnu sem styður við langtímamarkmið fyrirtækisins í vexti og nýsköpun. Starfið felur í sér yfirumsjón yfir deildir þvert á tækni- og verkfræðisviði. Ef þú hefur mikla tæknilega þekkingu, sterka leiðtogahæfileika og reynslu af GMP-umhverfi, þá er þetta tækifærið fyrir þig til að hafa raunveruleg áhrif á framtíð líftæknilyfja.



Helstu verkefni


 - Leiða deildir þvert á tækni- og verkfræðisvið.

 - Tryggja reglufylgni og öryggi í samræmi við GMP og ISO.

 - Leiða nýsköpun, stefnumótun og umbætur í tækni og ferlum.

 - Hafa umsjón með gerð og eftirfylgni fjárhagsáætlana

 - Samskipti við innri og ytri hagsmunaaðila.



Hæfniskröfur


 - Meistaragráða í verkfræði eða skyldum greinum.

 - 10+ ára reynsla í lyfjaiðnaði eða líftækni.

 - Leiðtogahæfni og reynsla af því að leiða umfangsmikil verkefni.

 - Yfirgripsmikil þekking á GMP og verkferlum í lyfjaframleiðslu.




[English]

Alvotech is a global biopharmaceutical company dedicated to the development and manufacture of high-quality biosimilar medicines. We are seeking a visionary and experienced Head of Engineering to lead our multidisciplinary engineering teams and drive strategic initiatives that support our long-term growth and innovation goals.



Key Responsibilities:


 - Develop and implement engineering strategies aligned with Alvotech’s long-term objectives.

 - Make critical decisions in engineering to ensure sustainability and regulatory compliance.

 - Oversee departments including Maintenance, Calibration, Facility Management, Commissioning &amp; Qualification, and Process Automation.

 - Promote collaboration and operational excellence across all engineering functions.



Role-Specific Responsibilities


 - Oversee and coordinate technology installations to support operational and business needs.

 - Ensure compliance with GMP, ISO, and other regulatory standards.

 - Drive process optimization and technological advancement.

 - Manage stakeholder communications and regulatory interactions.

 - Oversee budget preparation, tracking, and cost optimization.

 - Foster a culture of growth, learning, and high performance within the engineering team.

 - 10+ years of relevant experience in pharmaceutical or biotechnology industries.

 - Proven track record in managing large-scale engineering projects and cross-functional teams.

 - Strong background in GMP-compliant environments.



Skills &amp; Competencies:


 - Deep technical expertise in engineering and regulatory standards.

 - Exceptional leadership, strategic thinking, and problem-solving abilities.

 - Strong financial acumen and project management skills.

 - Excellent communication and stakeholder management capabilities.

 - Adaptability to VUCA (Volatility, Uncertainty, Complexity, Ambiguity) environments.



Certifications (Preferred):


 - PMP or equivalent project management certification.

 - Six Sigma, Lean, or other quality management certifications.

 - Leadership development and coaching training.



Qualifications:


 - Master’s degree in Engineering (Chemical, Mechanical, Biotechnology, Pharmacy, or related field).

 - 10+ years of relevant experience in pharmaceutical or biotechnology industries.

 - Proven track record in managing large-scale engineering projects and cross-functional teams.

 - Strong background in GMP-compliant environments.



What we offer:


 - An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.

 - The chance to be a part of a global and fast-growing company.

 - An international work culture that encourages diversity, collaboration and inclusion.

 - Positive, flexible, and innovative work environment.

 - Support for personal growth and internal career development.

 - Company social events and milestone celebrations.

 - Excellent in-house canteen and coffee house.

 - Exercise and wellbeing support for full-time employees.

 - On-site shower facility.

 - Transportation grant towards eco-friendly modes of travel for full-time employees.

 - Internet at home for full-time employees.



Why Alvotech
At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.
True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.

Head of Engineering / Sviðsstjóri tækni- og verkfræðisviðs

Overview of role
Are you passionate about quality and ready to take on a key role in ensuring excellence across the lifecycle of biologic products? Alvotech is looking for a Quality Lead to join our team and serve as the single point of contact for product quality oversight from development through commercialization.
Key Responsibilities:
<ul>
<li>Act as the primary Quality representative throughout the product lifecycle&mdash;from development to discontinuation.</li>
<li>Provide expert Quality support for GMP manufacturing, product release, regulatory requirements, and clinical/commercial supply.</li>
<li>Represent Quality in internal and external program meetings, including with strategic partners and CMOs.</li>
<li>Lead or participate in Quality-to-Quality meetings with partners and CMOs.</li>
<li>Ensure timely and accurate communication of Quality deliverables to strategic partners and CMOs.</li>
<li>Review and approve Quality documentation and QMS records, including those related to tech transfers, validation, and batch documentation.</li>
<li>Support QP in compiling release documentation and APQRs.</li>
<li>Assess change controls and notify partners of changes as per Technical Quality Agreements (TQAs).</li>
<li>Contribute to the alignment of TQAs with partners and CMOs.</li>
</ul>
Qualifications:
<ul>
<li>Minimum 5 years of relevant experience in a GMP environment within the biopharmaceutical industry.</li>
<li>Deep understanding of Quality functions including QA, QC, Compliance, and Documentation.</li>
<li>Hands-on experience with QMS processes such as Deviations, Change Controls, and CAPAs.</li>
<li>Strong knowledge of global regulatory standards and expectations.</li>
<li>Familiarity with GMP-impacting systems such as Veeva, SAP, and LIMS.</li>
<li>Proven experience working with CMOs and strategic partners.</li>
<li>Skilled in remote leadership and communication.</li>
<li>Knowledge of Operational Excellence, Project Management, or Lean tools is a plus.</li>
</ul>
(Icelandic)
Ertu me&eth; brennandi &aacute;huga &aacute; g&aelig;&eth;um og tilb&uacute;in(n) a&eth; taka a&eth; &thorn;&eacute;r lykilhlutverk &iacute; a&eth; tryggja g&aelig;&eth;avottun l&iacute;ft&aelig;knilyfja fr&aacute; &thorn;r&oacute;un til marka&eth;ssetningar? Vi&eth; hj&aacute; Alvotech leitum a&eth;&nbsp;g&aelig;&eth;alei&eth;toga sem mun bera &aacute;byrg&eth; &aacute; samr&aelig;mdri g&aelig;&eth;astj&oacute;rn &iacute; gegnum allt l&iacute;ft&iacute;mabil v&ouml;runnar.
Helstu verkefni
<ul>
<li>Vera tengili&eth;ur fyrir g&aelig;&eth;am&aacute;l &iacute; &thorn;r&oacute;unar-, framlei&eth;slu- og marka&eth;sferlum l&iacute;ft&aelig;kniv&ouml;ru.</li>
<li>Veita s&eacute;rfr&aelig;&eth;ia&eth;sto&eth; vi&eth; GMP framlei&eth;slu, v&ouml;ru&uacute;tg&aacute;fu, kr&ouml;fur heilbrig&eth;isyfirvalda og kl&iacute;n&iacute;skar/marka&eth;sbirg&eth;ir.</li>
<li>Taka &thorn;&aacute;tt &iacute; innri og ytri fundum sem fulltr&uacute;i g&aelig;&eth;adeildar, m.a. me&eth; samstarfsa&eth;ilum og samningsframlei&eth;endum (CMOs).</li>
<li>St&yacute;ra e&eth;a taka &thorn;&aacute;tt &iacute; fundum um g&aelig;&eth;am&aacute;l me&eth; samstarfsa&eth;ilum og CMOs.</li>
<li>Tryggja skilvirk og r&eacute;tt samskipti um g&aelig;&eth;askj&ouml;l og afhendingar til samstarfsa&eth;ila og CMOs.</li>
<li>Sko&eth;a og sam&thorn;ykkja g&aelig;&eth;askj&ouml;l og QMS f&aelig;rslur, m.a. tengdar t&aelig;kniflutningi, sta&eth;festingarferlum og lotuskj&ouml;lum.</li>
<li>A&eth;sto&eth;a vi&eth; samantekt &uacute;tg&aacute;fuskjala og &aacute;rssk&yacute;rslna (APQR) fr&aacute; CMOs.</li>
<li>Meta breytingast&yacute;ringar og tilkynna samstarfsa&eth;ilum um breytingar &iacute; samr&aelig;mi vi&eth; TQA samninga.</li>
<li>Tryggja samr&aelig;mi &iacute; t&aelig;knilegum g&aelig;&eth;asamningum (TQA) milli Alvotech og samstarfsa&eth;ila.</li>
</ul>
H&aelig;fniskr&ouml;fur
<ul>
<li>A&eth; minnsta kosti 5 &aacute;ra reynsla &iacute; GMP umhverfi innan l&iacute;ft&aelig;knilyfjai&eth;na&eth;arins.</li>
<li>G&oacute;&eth; &thorn;ekking &aacute; g&aelig;&eth;astj&oacute;rnun, m.a. QA, QC, samr&aelig;mi og skj&ouml;lun.</li>
<li>Reynsla af QMS kerfum, m.a. fr&aacute;vikum, breytingast&yacute;ringum og CAPA ferlum.</li>
<li>&THORN;ekking &aacute; al&thorn;j&oacute;&eth;legum regluverkum og kr&ouml;fum heilbrig&eth;isyfirvalda.</li>
<li>Kunn&aacute;tta &aacute; kerfum sem hafa &aacute;hrif &aacute; GMP, t.d. Veeva, SAP og LIMS.</li>
<li>Reynsla af samskiptum vi&eth; samningsframlei&eth;endur og samstarfsa&eth;ila.</li>
<li>Lei&eth;togah&aelig;fni &iacute; fjarvinnuumhverfi.</li>
<li>&THORN;ekking &aacute; Operational Excellence, verkefnastj&oacute;rnun og/e&eth;a Lean a&eth;fer&eth;um er kostur.</li>
</ul>


Overview of role

Are you passionate about quality and ready to take on a key role in ensuring excellence across the lifecycle of biologic products? Alvotech is looking for a Quality Lead to join our team and serve as the single point of contact for product quality oversight from development through commercialization.

Key Responsibilities:


 - Act as the primary Quality representative throughout the product lifecycle—from development to discontinuation.

 - Provide expert Quality support for GMP manufacturing, product release, regulatory requirements, and clinical/commercial supply.

 - Represent Quality in internal and external program meetings, including with strategic partners and CMOs.

 - Lead or participate in Quality-to-Quality meetings with partners and CMOs.

 - Ensure timely and accurate communication of Quality deliverables to strategic partners and CMOs.

 - Review and approve Quality documentation and QMS records, including those related to tech transfers, validation, and batch documentation.

 - Support QP in compiling release documentation and APQRs.

 - Assess change controls and notify partners of changes as per Technical Quality Agreements (TQAs).

 - Contribute to the alignment of TQAs with partners and CMOs.


Qualifications:


 - Minimum 5 years of relevant experience in a GMP environment within the biopharmaceutical industry.

 - Deep understanding of Quality functions including QA, QC, Compliance, and Documentation.

 - Hands-on experience with QMS processes such as Deviations, Change Controls, and CAPAs.

 - Strong knowledge of global regulatory standards and expectations.

 - Familiarity with GMP-impacting systems such as Veeva, SAP, and LIMS.

 - Proven experience working with CMOs and strategic partners.

 - Skilled in remote leadership and communication.

 - Knowledge of Operational Excellence, Project Management, or Lean tools is a plus.


(Icelandic)

Ertu með brennandi áhuga á gæðum og tilbúin(n) að taka að þér lykilhlutverk í að tryggja gæðavottun líftæknilyfja frá þróun til markaðssetningar? Við hjá Alvotech leitum að
gæðaleiðtoga sem mun bera ábyrgð á samræmdri gæðastjórn í gegnum allt líftímabil vörunnar.

Helstu verkefni


 - Vera tengiliður fyrir gæðamál í þróunar-, framleiðslu- og markaðsferlum líftæknivöru.

 - Veita sérfræðiaðstoð við GMP framleiðslu, vöruútgáfu, kröfur heilbrigðisyfirvalda og klínískar/markaðsbirgðir.

 - Taka þátt í innri og ytri fundum sem fulltrúi gæðadeildar, m.a. með samstarfsaðilum og samningsframleiðendum (CMOs).

 - Stýra eða taka þátt í fundum um gæðamál með samstarfsaðilum og CMOs.

 - Tryggja skilvirk og rétt samskipti um gæðaskjöl og afhendingar til samstarfsaðila og CMOs.

 - Skoða og samþykkja gæðaskjöl og QMS færslur, m.a. tengdar tækniflutningi, staðfestingarferlum og lotuskjölum.

 - Aðstoða við samantekt útgáfuskjala og ársskýrslna (APQR) frá CMOs.

 - Meta breytingastýringar og tilkynna samstarfsaðilum um breytingar í samræmi við TQA samninga.

 - Tryggja samræmi í tæknilegum gæðasamningum (TQA) milli Alvotech og samstarfsaðila.


Hæfniskröfur


 - Að minnsta kosti 5 ára reynsla í GMP umhverfi innan líftæknilyfjaiðnaðarins.

 - Góð þekking á gæðastjórnun, m.a. QA, QC, samræmi og skjölun.

 - Reynsla af QMS kerfum, m.a. frávikum, breytingastýringum og CAPA ferlum.

 - Þekking á alþjóðlegum regluverkum og kröfum heilbrigðisyfirvalda.

 - Kunnátta á kerfum sem hafa áhrif á GMP, t.d. Veeva, SAP og LIMS.

 - Reynsla af samskiptum við samningsframleiðendur og samstarfsaðila.

 - Leiðtogahæfni í fjarvinnuumhverfi.

 - Þekking á Operational Excellence, verkefnastjórnun og/eða Lean aðferðum er kostur.

Why Alvotech

At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.

True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.