About the Opportunity
We are partnered with a rapidly growing biopharma that has an immediate need for a Principal Scientist (AD/Director level), Drug Substance Development focused within CMC. This remote position (Eastern/Central) is responsible for development and drug substance manufacturing activities of new and existing products at external Contract Manufacturing Organizations (CMOs).
The annual base salary range is $175,000 to $200,000. Actual compensation offered to the successful candidate may vary from posted hiring range based upon geographic location, work experience, education, and/or skill level, among other things. Details about eligibility for bonus compensation (if applicable) will be finalized at the time of offer.
Job Responsibilities
- Act as the drug substance subject matter expert and manage external DS development activities to support advancing product candidates in clinical studies. Support clinical phase and potential commercial launch activities
- Support technology transfer for manufacturing of clinical supplies from CMO to CMO to support scale up and late-stage development activities
- Develop, review, and approve technical reports and controlled GMP documentation such as manufacturing batch records, protocols, specifications, campaign reports, regulatory submission documents
- Oversee efforts and works closely with CMOs, Quality, Supply Chain, Regulatory CMC, Formulation and Analytical teams to ensure operational excellence and GMP compliance during manufacturing and timely release of drug substance for clinical use
Job Requirements
- MS/Ph.D. degree in Organic chemistry.
- At least 5 – 10 years of hands-on experience in small-molecule drug substance development and commercialization
- Strong technical background in developing and scaling up small molecule drug substance is required
- Thorough knowledge of cGMP, regulatory requirements, and approaches for implementation of Quality by design (QbD) principles, Design of Experiments (DoE) in DS development, process validation
