Process Development Scientist I at a contract development and manufacturing organization supporting pharmaceutical formulation and process design projects. The role involves laboratory testing, client collaboration, and technology transfer activities for small molecules and biologics including complex modalities.
Responsibilities
- Support formulation design, sterile filtration, and lyophilization for small molecules and biologics including ADCs
- Execute in-process and finished product testing using HPLC, UPLC, spectroscopy, and related assays
- Represent Process Development on internal and client-facing project calls with technical updates
- Draft and review batch records, protocols, SOPs, and controlled documents for compliance
- Lead and train junior-level Process Development Scientists
Requirements
- BS or MS in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or related field
- 0-5 years pharmaceutical development or CDMO industry experience
- Proficient laboratory and wet chemistry skills with cGMP and regulatory knowledge
- Experience with HPLC/UPLC, UV-Vis spectroscopy, and analytical characterization methods
- Proficiency in MS Office, SmartSheets, LabX, and Empower software
- Strong written and oral communication with ability to present technical updates to clients
Scientist I - Process Development in bedford at Unknown Company
This position is listed as contract and onsite.