CMC/Supply Chain Director

PharmAthene, Inc., a growing Biotech/biodefense firm based in Annapolis, Maryland is currently searching qualified professionals to fill two CMC/Supply Chain Directors created due to corporate growth.

The Directors will provide hands-on direction for outsourcing all aspects of pharmaceutical formulation development, including: formulation design, preparation of clinical supplies, packaging, scale-up, and process validation. Working as a member of a multi-disciplinary team, these positions ensure the development of novel, safe, and effective medicines in a timely and cost effective manner by handling several aspects of project management, technology assessment, and preparation of appropriate CMC sections for IND, NDA and BLA submissions, while ensuring that the contracted staff meet compliance requirements.

 

To be considered for these positions, the qualified candidate will have an advanced degree (MS/MA or PhD) in pharmacy, pharmaceutical sciences, chemical engineering, chemistry, or a related discipline, with at least 8 or more years of experience in oral formulation development (OR an equivalent combination of education and experience).  Additionally, the qualified candidate will have experience in authoring of CMC sections of regulatory submissions; a thorough understanding of GMP, cGMP, and other regulatory guidelines (dissolution, stability, packaging, bioequivalence, etc) related to pharmaceutical product development; a solid knowledge of basic chemistries (organic chemistry, physical chemistry, analytical chemistry, and medicinal chemistry, etc), pharmaceutics, pharmaceutical technology, engineering, and analytical chemistry; demonstrated knowledge in API, excipients, technology, and equipment, and;  experience in all phases and all aspects of new product development, including preparation of clinical supplies. Previous experience with biologics formulation and delivery is highly desired.

 

As these positions will directly support PharmAthene?s efforts relating to national defense, US citizenship or US Permanent Residency status will be required.

 

PharmAthene offers a fast paced/dynamic environment, growth opportunity, competitive compensation and a full benefits program.