Scientist II - Process Development

PCI Pharma Services seeks a Scientist II in Process Development for their Bedford, NH facility. The role involves leading formulation and process design projects for small molecules and biologics, including complex modalities like ADCs, with responsibility for experimental execution, analytical testing, documentation, and mentoring junior staff.

Responsibilities

• Lead process development projects as technical lead and subject matter expert for formulation and process design
• Execute and analyze experiments, develop phase-appropriate strategies, and troubleshoot analytical or process challenges
• Perform in-process and finished product testing using analytical techniques to confirm acceptance criteria
• Author, review, and maintain batch records, protocols, SOPs, and technical documentation for compliance
• Provide training and mentorship to junior scientists and collaborate cross-functionally with QC, Manufacturing, Operations, and external clients

Requirements

• PhD in Chemical Engineering, Pharmaceutical Sciences, Chemistry, or Biochemistry with 0-3 years pharma/CDMO experience, OR BS/MS with 5+ years experience
• Strong foundation in clinical-phase development and analytical characterization of biologics and complex modalities
• In-depth knowledge of biopharmaceutical regulation, formulation, filtration, filling, and lyophilization operations
• Proficiency in formulation design, sterile filtration, lyophilization, and process development for small molecules and biologics
• Experience with analytical instrumentation: HPLC/UPLC, UV-Vis spectroscopy, Flowcam, Karl Fischer titration, DSC/FDM
• Proficiency in MS Office, SmartSheets, LabX, and Empower software
• Ability to work independently, lead projects, manage multiple priorities, and mentor junior scientists