Scientist II PharmDev Analytical

Summary of Objective: The Scientist II position is a key collaborator of the Analytical 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 project management to support clients.

Responsibilities

Leads Analytical Development activities to support projects for various modalities, serving as the technical lead and SME for analytical methods development and testing; Supports more complex formulation and process development projects as an Analytical Development SME; 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 and other complex modalities; Drives analytical methods transfer activities to QC and provides support in scale-up or manufacturing process transitions; Performs analytical testing within Pharmaceutical Development laboratory, such as HPLC/UPLC, Capillary Electrophoresis, UV-Vis spectroscopy, FlowCam, Karl Fischer titration, DSC/FDM, and other related assays; 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; Reviews executed documentation for accuracy and completeness prior to submission to management; Drafts and maintains Standard Operating Procedures and related controlled documents; Provides technical guidance and mentorship to junior scientists and laboratory staff

Requirements

Advanced Degree (PhD) in Pharmaceutical Sciences, Chemistry, Analytical Chemistry, Biochemistry, or related fields with 0-3 years’ experience in pharmaceutical development or CDMO industry; MS/BS in Pharmaceutical Sciences, Chemistry, Analytical Chemistry, Biochemistry, or 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; 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