Drug Product Manager
Location – Germantown, Maryland
Salary: Attractive salary + benefits including fully funded health care for yourself and your immediate family including dental and vision care, bonus and stock options
A rare position has arose, to work with a clinical stage immunotherapy and vaccine company, developing products to treat and prevent infectious disease. This is a fantastic opportunity to be part of a well-funded business on a rapid growth trajectory. With a powerful suite of innovative technologies, this a truly exciting time to join the company.
With their growth plans, they are looking to add a Drug Product Manager, who will act as a key member in the manufacturing team. Reporting directly to the Head of Manufacturing and Peptides, you will have the opportunity to work independently with CDMOs for the preparation and timely delivery of peptide drug products.
Responsibilities, though not limited to:
- Responsible for managing formulation development, tech transfer and manufacturing activities at the CDMOs of peptide drug products.
- Work with CDMOs to Design and perform quality scientific experimentation to develop robust processes in support of Formulation and Process Development activities.
- Analyse and defend scientific results from experiments, design, and conduct stability studies, generate accurate, reliable data by following established protocols and practices to support product development, and summarise, interpret, report, and results.
- Author, review and strategically impact regulatory filings (including INDs, IMPD, briefing packages and other regulatory dossiers) and updates.
- Communicate effectively to the management team, project manager, and the wider development team and presents data at team meetings and departmental technical meetings.
Qualifications:
- Familiar with the state-of-the-art equipment used in Drug Product manufacturing and analysis.
- Ph.D. with at least 8 years of related technical experience, or a masters with 12 years of experience, required within the biopharmaceutical industry.
- Comprehensive Knowledge of the principles and practices of pharmaceutical sciences combined with professional experience in developing and testing peptide parenteral formulation processes.
- Excellent Writing skills as they relate to preparation of RFPs, RFQs, protocols, and reports.
- Understanding of cGMP requirements, ICH, and regulatory guidance.
- Familiarity with Quality and Regulatory Affairs as applicable to CDMOs compliance and regulatory filings
If you are interested in wanting to part of a growth journey and cutting edge science please send your CV to [email protected], and let’s arrange a conversation!
Cpl Life Sciences
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