Chemist

Looking for a Process Chemist with drug substance manufacturing facilities, process development, scale up, process validation and regulatory CMC submissions in a Bio/Pharma environment. The qualified candidate must have experience with CMO/vendor/interdepartmental or other external party coordination. This individual will be communicating with CMOs to alleviate issues and must have experience entering FDA investigations into a database. Contract assignment in the Boston, MA area.

RESPONSIBILITIES

- Provide technical support in manufacturing process design, optimization, scale-up, technology transfer, and validation activities of small molecule API manufacturing process.
- Provide day-to-day technical support for commercial drug substance manufacturing - i.e., trouble shooting, process changes and improvements, new manufacturing technology implementation etc.
- Collaborate with Process Chemistry (Pharmaceutical Sciences) group in process development, process validation and all CMC activities of new product development

REQUIREMENTS

- BS & 8 years of experience, MS & 5 years, or PhD & no more than 2 years of experience in similar roles.
- Previous pharma/biotech experience is a must
- Knowledgeable in drug substance manufacturing facilities, unit operations, process control, modern analytical methodologies and instrumentation.
- Extensive experiences in process development, scale up, process validation, regulatory CMC submissions.
- Must be familiar with current regulatory requirements for drug substance manufacturing, i.e., cGMP, ICH, USP/EP, SUPAC, etc.

BENEFITS