Senior CMC Lead Vaccine Development
Employment type: Full-time
About Batavia Biosciences
Batavia helps to optimize the route from drug discovery to clinic by being a thought partner for our customers. By leveraging the combination of our expert workforce, our broad, international academic and public network and our extensive range of high-end services, we design the optimal route for our customers to reach the one person that we all are 100% committed to: the patient.
To help us take biopharmaceutical development to the next level, our team would love to welcome you as our new Senior CMC Lead Vaccine Development.
About the job
We are looking for a Senior CMC Lead within our Operations department. In this role you take leadership in driving cross-functional CMC development strategies for key vaccine development programs and you provide scientific oversight into the process design for preclinical, clinical and commercial phase vaccine candidates. You bring scientific, regulatory and GMP expertise in the development of manufacturing processes (viral vector development, USP, DSP and Assays for Vaccines and/or viral vectors) and you will be the CMC spokesperson in regulatory interactions. The Senior CMC Lead reports to the Director Operations.
Your letter of motivation and CV should show that you have:
- PhD or equivalent in a relevant field, such as Biotechnology, Life Sciences.
- Over 7 years of relevant work experience in Biopharmaceutical industry including preclinical / clinical process development.
- Proven expertise in developing and executing CMC strategies for biotechnology/pharmaceutical products, preferably for viral vaccines.
- Proven experience with regulatory filings (IMPD/IND/MAA/BLA).
- Good communication skills (written/spoken) and fluent in English.
- Strong interpersonal skills – able to work effectively with different kinds of communities.
- Ability to be independent, multitask and results oriented with hands-on attitude in a dynamic environment.
- Experience with C(D)MO activities would be a plus.
In the interviews you should show that:
- You are able to develop and maintain CMC strategies for the company’s key vaccine development programs.
- You are able to design CMC development strategy in line with pre-defined project and business objectives, state-of-the-art scientific knowledge and regulatory guidelines.
- Using your knowledge and empathy, you can build a good team spirit in which highly educated professionals will work together effectively.
- You are able to communicate accurately and effectively with all project stakeholders.
- You have a good sense of the business environment and you are flexible in supporting the objectives of the company.
Please send your application to Mrs. I. van Aarle, HR Manager, email@example.com
No unsolicited assistance from search firms is accepted for this employment opportunity.