Chemist

Immediate long term contract position in the Boston, MA area for a Process Chemist for a great company!! The contractor will provide technical support in manufacturing process design, optimization, scale-up, technology transfer, and validation activities of small molecule API manufacturing process. The incumbent will also act as a technical liaison and responsible for overseeing third-party manufacturing in support of clinical trials and commercial products. All applicants should have a minimum of 5 years of Process Chemistry experience, and exposure to late stage or commercial environments. Must be familiar with working cross functionally with Quality, Regulatory, and Clinical. This is a 12+ month contract with long term potential at one of Boston's best companies to work for.

RESPONSIBILITIES

- Provide day-to-day technical support for commercial drug substance manufacturing
- Manage CMO manufacturing activities - act as a technical liaison between Technical Operations and third-party drug substance manufacturers to effectively manage drug substance manufacturing
- Coordinate among various Pharmaceutical Operations groups (Supply Ops, QA, QC) in compiling and analyzing production data, such as IPC, release, and manufacturing process information
- Collaborate with Process Chemistry group in process development, process validation and all CMC activities of new product development
- Work with QA and compliance groups to validate drug substance manufacturing processes for regulatory submissions, preparation for PAI and commercial production
- Manage change controls, investigations, deviations, and lead CAPA and MRB
- Author/co-author pertinent CMC sections for regulatory submissions, NDA and post-approval changes

REQUIREMENTS

- Ph.D. 5+ years experience in drug development and commercial manufacturing, or MS with 10+ years experience, with a strong process chemistry background
- Knowledgeable in drug substance manufacturing facilities, unit operations, process control, modern analytical methodologies and instrumentation
- Have extensive experiences in process development, scale up, process validation, regulatory CMC submissions
- Familiar with current regulatory requirements for drug substance manufacturing, i.e., cGMP, ICH, USP/EP, SUPAC, etc.
- Must have demonstrated skills in communication, organization, teamwork and management

BENEFITS