Scientist II PharmDev Formulations

PCI Pharma Services•Bedford, NH

16h

About The Position

The Scientist II position is a key collaborator of the Formulation Development team in Pharmaceutical Development department within a fast-paced, expanding CDMO. This job will require both support and leadership in hands-on experimentation, testing, and strategic technical project management to support clients.

Requirements

Advanced Degree in (PhD) in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or other related fields with 0-3 years’ experience in pharmaceutical development or CDMO industry.
BS/MS in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or other related fields with 5+ years’ experience in pharmaceutical development or CDMO industry.
A strong foundation in clinical-phase development and analytical characterization of drug products, including biologics and other complex modalities.
In-depth knowledge of biopharmaceutical and/or medical product regulation, formulation, filtration, filling, and lyophilization operations.
Experience with MS Office (Word/Excel/Teams/PowerPoint/SharePoint), SmartSheets, LabX, and Empower.
Detail oriented and a results-driven team player.
Ability to work in a dynamic, fast-paced work environment.
Honesty, integrity, respect and courtesy with all colleagues.
Creative with the ability to work with minimal supervision and balance with independent thinking.
Resilient through operational and organizational change.

Responsibilities

Leads Formulation Development projects for various modalities, serving as the technical lead and SME for formulation and process design activities.
Supports more complex Formulation Development projects as a collaborator, working with a senior scientist to achieve project milestones.
Executes and analyze experiments to achieve project milestones without supervision.
Develops and implements phase-appropriate formulation development strategies aligned with program objectives and regulatory expectations.
Acts as a Formulation Development representative on internal and client-facing project calls, providing technical updates and strategic input.
Demonstrates proficiency in formulation design for both small molecules and biologics, analytical data interpretation and trending.
Develops and optimizes formulations for high-potency compounds, including antibody-drug conjugates (ADCs) and other complex modalities.
Supports technology transfer activities and assists in scale-up or manufacturing transitions as a formulation SME.
Performs analytical testing within Pharmaceutical Development laboratory to support formulation development, such as HPLC/UPLC, Capillary Electrophoresis, UV-Vis spectroscopy, FlowCam, Karl Fischer titration, DSC/FDM, and other related assays to confirm acceptance criteria as part of formulation development activities.
Troubleshoots formulation, analytical and process challenges and proposes scientifically sound corrective actions.
Responsible for proper maintenance, calibration, and cleanliness of laboratory instruments and equipment.
Performs or assists in routine facilities cleaning and equipment upkeep as required.
Authors and reviews Formulation Development records, protocols, and reports to ensure technical accuracy and compliance with quality standards and client demand.
Reviews executed documentation for accuracy and completeness prior to submission to management.
Drafts and maintains Standard Operating Procedures (SOPs) and related controlled documents for Pharmaceutical Development operations.
Provides training, technical guidance, and mentorship to junior scientists and laboratory staff.
Collaborates cross-functionally with internal stakeholders including Manufacturing Technical Services (MTS), and Operations, as well as external client teams, to ensure alignment and successful project execution.