Scientist II, PharmDev Formulation

Essential Duties And Responsibilities

• Leads Formulation Development projects for various modalities, serving as the technical lead and SME for formulation and process design activities.
• Serves 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 analyzes 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.
• Troubleshoot 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.

Qualifications

• BS/MS in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or other related fields required with 3-5+ years’ experience in pharmaceutical development or CDMO industry.
• PhD in Pharmaceutical Sciences, Chemistry, Biochemistry, or other related fields preferred with 0-3 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.