Scientist, Analytical Development (Biologics)
Greater Boston Area
Competitive Compensation + excellent bonus/benefits
Duties and Responsibilities:
- Able to facilitate, analyze and interpret the data from experiment results
- Ensure protocols follow company policies, ICH, GMP, USP and FDA regulations
Experience:
- Strong communication, organization, and multitasking skills are needed to lead
- Install new equipment, processes, and methods for the solution of technical problems
- Will work and manage in-house and outsourced lab activities.
- Will focus on the Biologics Portfolio
- Focus on multiple compounds within their pipeline (approaching phase III and Commercialization)
- Operate wet chemistry instruments such as HPLC, ELISA, qPCR, CE-SDS, etc.
Qualifications:
- Have experience in method development (ideally from scratch)
- Experience overseeing outsourced vendors (CROs/CMOs/CTLs/CDMOs)
- Experience overlooking multiple drug candidates within the company's pipelines
- M.S or Ph.D. in Chemistry or a related scientific field with ideally 5-7 years of industry
- experience
- Experience authoring CMC sections for IND, BLA and NDA is highly sought after
