(Senior) CMC Expert*
Here, you’ll achieve greatness.At BioNTech, you will be responsible for supporting our project teams from start of the development of biologics up to launch in major markets. Your primary duties include:
- In partnership with program teams, act as a CMC expert for BioNTech’s development projects from start of development through product launch
- In close collaboration with BioNTech’s project management and CMC functions, drive and guide the cross-functional CMC content using sound knowledge of global regulatory guidelines
- Together with your colleagues in CMC Regulatory Affairs, ensure that the content of CMC data-packages and documentation meet state of the art regulatory expectations; Support the teams in regulatory submissions by writing and reviewing relevant CMC documents/dossiers
- Identify critical CMC development issues and proactively implement activities for their resolution
- In partnership with senior leadership, drive the development of the CMC strategy and innovation for the Company’s technologies
- Participate in the development, implementation and improvement of CMC regulatory processes, procedures and SOPs
What you have to offer.
- Degree in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry or Biology with 5+ years professional experience in an international, pharmaceutical environment; Oligonucleotides, gene and/or cell therapies experience is highly preferred
- Sound knowledge of working in different scientific/technical CMC development functions (process development, pharmaceutical and/or analytical development, manufacturing); Documented experience in CMC regulatory affairs would be a plus
- In depth CMC development knowledge in either early or late stage projects with sound understanding of all stages of drug development; Experience with regulatory filings for biologicals (IND/IMPD, BLA/MAA) is considered preferred
- Significant management and leadership background is required
- Experience creating regulatory documents/dossiers for clinical trials and market approval is highly preferred
- Adaptability, strategic mindset, innovative yet pragmatic/solution-oriented thinking, and attention to detail with a strong orientation to quality required, Effective negotiation skills
- Fluent English language skills and professional-level communication skills (i.e., oral, written) required; Ability to communicate complex information to senior leadership
- Willingness to travel locally, regionally and internationally
Benefits for you.
Have we kindled your pioneering spirit?Then apply now for our location Mainz and simply send us your application documents using our online form.
If you have any further questions, Andy Wingstrom will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon).
*BioNTech does not differentiate on the basis of gender, race, religion, color, origin, sexual orientation, disability, age and other protected status as required by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer.
BioNTech - As unique as you