Scientist II PharmDev Formulations

PCI Pharma Services
Bedford, NH, United States
2 days ago

Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Experience level
Expert
Experience required
5 years minimum
Working hours
Regular working hours

Tech stack

Data Analysis Microsoft Office

Job description

Experteer Overview In this role, you lead and contribute to Formulation Development projects within a fast-paced CDMO, guiding strategy, execution, and transfer activities. You collaborate with cross-functional teams to align formulation strategies with regulatory expectations and client needs. You will work on small molecules, biologics, and high-potency modalities including ADCs, shaping projects from concept to scale-up. This position blends hands-on experimentation with technical leadership to deliver robust, compliant formulations that support client programs and manufacturing transitions. Compensation / Benefits * Lead formulation development projects as technical lead and SME for design activities across modalities * Support complex projects alongside a senior scientist to reach milestones * Execute experiments and analyze data to meet project objectives with minimal supervision * Develop phase-appropriate formulation strategies aligned with program goals and regulatory expectations * Represent Formulation Development in internal and client-facing calls with technical updates * Demonstrate proficiency in formulation design for small molecules and biologics, including data interpretation * Develop and optimize formulations for high-potency compounds and ADCs * Support technology transfer and scale-up as a formulation SME * Perform analytical testing (HPLC/UPLC, Capillary Electrophoresis, UV-Vis, FlowCam, Karl Fischer, DSC/FDM, etc.) to confirm acceptance criteria * Troubleshoot formulation and analytical/process issues with scientifically sound actions * Maintain and calibrate laboratory instruments; assist with facilities cleaning and upkeep * Author/review development records, protocols, and reports for accuracy and compliance * Draft and maintain SOPs and controlled documents for Pharmaceutical Development operations * Provide training, guidance, and mentorship to junior staff * Collaborate cross-functionally with Manufacturing Technical Services, Operations, and external client teams Tasks * PhD in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or related field with 0-3 years’ pharmaceutical development/CDMO experience * BS/MS in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or related field with 5+ years’ pharmaceutical development/CDMO experience * Strong foundation in clinical-phase development and analytical characterization of drug products, including biologics and complex modalities * Knowledge of biopharmaceutical/product regulation and formulation, filtration, filling, and lyophilization operations * Experience with MS Office, SmartSheets, LabX, and Empower Key requirements *

Requirements

_ and external client teams Tasks * PhD in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or related field with 0-3 years’ pharmaceutical development/CDMO experience * BS/MS in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or related field with 5+ years’ pharmaceutical development/CDMO experience * Strong foundation in clinical-phase development and analytical characterization of drug products, including biologics and complex modalities * Knowledge of biopharmaceutical/product regulation and formulation, filtration, filling, and lyophilization operations * Experience with MS Office, SmartSheets, LabX, and Empower Key requirements *

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