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.
Essential Duties and 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, 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 QC and provides supports in scale-up or manufacturing process transitions as an analytical development SME.
- Performs analytical testing within 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 as part of formulation development activities.
- 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.
- Drives analytical methods transfer activities to QC and provides supports in scale-up or manufacturing process transitions as an analytical development SME.
Qualifications: EDUCATION/EXPERIENCE:- Advanced Degree in (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 with independent thinking
- Resilient through operational and organizational change
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