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Scientist / Senior Scientist, Formulation Development

Position Summary:

We seek a highly motivated individual to lead and execute formulation development activities for solid and parenteral dosage forms while maintaining the highest ethical and technical standards. The successful candidate will act as the resident subject matter expert to educate, influence, and implement clinical phase appropriate formulation development strategies. The candidate will be expected to independently execute and document laboratory experimentation, prepare summaries / technical reports, and communicate findings to peers and senior management. The candidate is expected to be familiar with the technical transfer process and regularly interface with contract organizations to support development and manufacturing of drug products. The ideal candidate keeps abreast of key product development technologies, regulatory initiatives, and contract manufacturing landscape.

Primary Responsibilities:

  • Lead the drug product development efforts for the oral / parenteral dosage forms along with associated analytical and clinical manufacturing activities.
  • Lead the screening of a broad range of drug delivery systems thus allowing strategic selection of fit-for-purpose dosage forms for drug candidates from early toxicology studies through clinical development.
  • Ensure development and execution of integrated project plans including milestones, timelines, resources and budgets. Oversee, audit, and recommend external partners. Ensure timely availability of clinical supplies.
  • Manage multiple CMO’s and CRO’s. Review CMO batch records and prepare reports and other development-related documents in support of drug product CMC sections for regulatory submissions.
  • Create and maintain seamless interaction with other departments including chemical process development, non-clinical, quality, regulatory, clinical, as wells as external partners. As appropriate, lead multidisciplinary CMC team for designated projects.
  • Evolve and maintain department knowledge to future industry standards, for example responsible for the design and execution of high quality experimentation leading to the generation of QbD data or enhancing process understanding via the use of statistical process modeling.

Education and Experience:

  • Ph.D. or M.S. in Pharmaceutics, Chemical Engineering or a related discipline with a minimum of 2 to 5 (for scientist) or 6 - 10 (for Senior Scientist) years respectively of relevant industry experience is required.
  • Fundamental understanding of principles of physical pharmacy and solid state chemistry as they relate to preformulation and dosage form selection is essential.
  • Hands on experience with solid and/or parenteral dosage form manufacturing equipment and processes is highly desired. Understanding of statistical and QbD principles for drug product manufacturing is a plus.
  • Familiarity with regulatory requirements and quality standards in the US and EU including cGMP and GLP guidelines is required.
  • Proven ability to execute projects under aggressive timelines and provide creative solutions to complex pharmaceutics issues in a dynamic, fast paced environment.
  • Strong organization, interpersonal, and verbal communications skills are highly desired. The candidate must provide a track record of peer reviewed scientific abstracts or publications as demonstration of her/his technical writing skills.
  • Ability and willingness to travel (up to 20% - domestic and international).
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