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.
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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.
- 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.