Overview Of Role
The Stability Strategy Lead is responsible for the overall stability strategy of the company. He/she leads the cross-functional Stability Working Group, to develop program specific stability strategies for all company programs. The role requires strong familiarity with the relevant stability guidelines and involves interpretation of those, ensuring they are being met. The stability strategy lead is responsible for the design of stability studies executed within Research and Development (R&D), as well as QC, and the evaluation and trending of data. He/she is responsible for the shelf life setting strategy of the programs and is the accountable author of stability sections of briefing books, IMPD/INDs and CTD.
The candidate should ideally have a strong analytical background including protein degradation, ideally experience with biosimilars, and with a good understanding of regulatory guidelines and expectations with regards to stability. He/she should have good communication skills and be able to work in a matrix environment, as close collaborations with other functions is required.
Scope and responsibility:
- Responsible for the overall general stability strategy of the company, in collaboration with the Stability Working Group and the Specification and Stability review board. Including interpretation of the stability guidelines and ensuring that these are being met.
- Lead the Stability Working Group to develop program specific stability strategies for all company programs, for endorsement by the Specification and Stability review board.
- Communicate program specific stability strategies to the Co-Development Sub Team (CDST) and the Program Team.
- Responsible for the design of stability studies executed within Research and Development (R&D) and the evaluation and trending of data.
- Responsible for stability sections of briefing books, IMPDs/INDs and CTD.
- Responsible for the shelf life setting strategy of the programs.
- Work with the relevant functions to trigger stability discussions at required timepoints for both R&D and GMP batches in the development programs.
- Be the key point of contact for stability related questions. Bring stability questions in for discussion in the working group.
Job requirements:
- BSc in a scientific subject, preferably biotechnology or similar
- Experience in technical report writing
- Desired experience in regulatory documents writing
- Sound scientific background with experience in data gathering, summarizing and evaluation
- Good working knowledge and experience with Word and Excel essential, including figure generation
- Any additional programs are a benefit, e.g. Prism (GraphPad), JMP
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 agileenvironment.
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.
