Analytical Scientist II

About the Role

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

Responsibilities

• Leads Analytical Development activities to support projects for various modalities, serving as the technical lead and subject matter expert (SME) for analytical methods development and testing.
• Supports complex formulation and process development projects as an Analytical Development SME, working with a senior scientist to achieve project milestones.
• Executes method development and transfer to achieve project milestones without supervision.
• Develops and implements phase-appropriate analytical method development strategies aligned with program objectives and regulatory expectations.
• Acts as an Analytical Development representative on internal and client-facing project calls, providing technical updates and strategic input.
• Demonstrates proficiency in method development for both small molecules and biologics, analytical data interpretation, and trending.
• Develops and optimizes analytical methods to support formulations development for high-potency compounds, including antibody-drug conjugates (ADCs) and other complex modalities.
• Drives analytical methods transfer activities to Quality Control (QC) and provides support in scale-up or manufacturing process transitions as an analytical development SME.
• Performs analytical testing within the Pharmaceutical Development laboratory to support formulation and process development, such as HPLC/UPLC, Capillary Electrophoresis, UV-Vis spectroscopy, FlowCam, Karl Fischer titration, DSC/FDM, and other related assays to confirm acceptance criteria.
• Provides training on analytical methods execution for formulation and process development scientists.
• Troubleshoots analytical methods 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 Analytical 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 technical guidance and mentorship to junior scientists and laboratory staff.

Qualifications

Education & Experience

• Must have experience with 2 of the 3: size exclusion (HPLC), capillary electrophoresis (CE), cIEF (capillary isoelectric focusing) assay.
• Advanced Degree (PhD) in Pharmaceutical Sciences, Chemistry, Analytical Chemistry, Biochemistry, or other related fields with 0-3 years’ experience in pharmaceutical development or CDMO industry.
• MS/BS in Pharmaceutical Sciences, Chemistry, Analytical Chemistry, Biochemistry, or other related fields with 3/5+ 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, analytical methods development for small and large molecules.
• 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 independent thinking.
• Resilient through operational and organizational change.