Summary of Objective:

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.

Essential Duties and 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.

Qualifications:

EDUCATION/EXPERIENCE:

• 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      

QUALITIES:

• 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

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