PharmSci Lead

Alvotech leitar eftir öflugum aðila í hlutverkið Pharmaceutical Sciences Lead, þar sem helsta verkefnið er að hafa yfirsýn yfir þróunarvinnunni innan PharmSci og vera hvatberi samskipta og samvinnu milli allra deilda sem koma að verkefninu frá upphafi þess, til umsóknar til yfirvalda og samþykkis á verkefninu frá yfirvöldum. Í þessu lykilhlutverki vinnur aðilinn með mörgum mismunandi deildum innan þróunarinnar (e. CMC development) (þ.m.t. Process Development, Analytical Development, MSAT, o.s.frv.), þar sem sameiginlegt markmið er að finna nýstárlega stefnu til þróunar og framkvæma þá stefnu til að tryggja framvindu verkefnisins. Hlutverkið gefur tækifæri til að vinna með öðrum deildum innan Alvotech, þar sem aðilinn mun leiða þverfaglegt teymi sem vinnur að þróuninni ásamt því að vera fulltrúi þróunarteymisins innan annarra teyma sem koma að verkefninu, til að tryggja árangur verkefnisins (t.d. Clinical, Regulatory, Commercial, o.s.frv.).

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 á heimasíðu okkar.

[English]

Overview of role:

Alvotech is looking to hire a dynamic Pharmaceutical Sciences Lead to oversee and coordinate all PharmSci development activities from program inception through submission and approval. In this pivotal role, you'll collaborate with various line functions responsible for the CMC development (e.g. Process Development, Analytical Development, MSAT etc.) to craft innovative PharmSci strategies and drive the execution of the strategies to ensure efficient progression of the CMC activities. Leading the technical development sub-team, you'll also represent the PharmSci function in program team meetings, working closely with different stakeholders across the organization (e.g. Clinical, Regulatory, Commercial etc.) and contribute to the overall advancement of the programs.

Key Responsibilities:

• Lead the Co-development sub-team and represent the function in cross-functional teams.
• Co-ordinate with the relevant stakeholders to design the strategy for CMC development
• Drive the CMC activities to ensure timely delivery with high quality.
• Communicate PharmSci activities and their impact on program timelines.
• Oversee PharmSci data to maintain scientific excellence.
• Support due diligence activities.
• Foster effective team dynamics and communication.
• Lead the authoring of CQA, QTPP, and related documents.
• Strategize, author and review regulatory submission documents (IMPD, Briefing book, MAA etc.).
• Manage PharmSci risks and challenges.
• Support daily operations as needed.

Qualifications:

• M.Sc. degree in a relevant scientific discipline with industry experience.
• Over 5 years of international experience in PharmSci R&D, preferably with biosimilars.
• Proven leadership in PharmSci functions for biological products.
• Strong analytical, problem-solving, and organizational skills.
• Excellent written and oral communication skills.
• Deep scientific knowledge in process and/or analytics for biological products.
• Passion for scientific problem solving.
• Exceptional communication skills and ability to motivate team members.

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.

We encourage you to visit our Career page (link: Join us - Alvotech - Better Access Better Lives) It offers valuable insights into our culture, values, and the innovative work we do.