Analytical Development Scientist

Vertex Pharmaceuticals • Boston, MA

9d • $113,464 - $132,400 • Onsite

About The Position

Perform a variety of well-defined, supportive functions including leading design and execution of analytical procedures that support development of cell therapy products. Develop, qualify and validate new test methods for characterization, purity and potency of hESCs and iPSC derived cell intermediates and drug products. Rapidly incorporate and adapt longstanding methods to the most recent FDA guidelines. Generate hypotheses and creative solutions to pursue Project goals, set new experimental directions, and overcome obstacles. Establish assay design criteria using Design of Experiments (DOE) and other contemporary development tools. Successfully transfer complex cell-based assays to QC and provide SME support for qualification and validation, including authoring and reviewing of protocols and reports. Develop and manage analytical commercial capabilities and strategies to ensure robust and compliant analytical methods and testing for commercial requirements. Provide technical recommendations broadly within the company regarding own field and play a key Project Role.

Requirements

• Employer will accept a Masters's degree, or foreign equivalent, in Pharmacology or a related field and 4 years of experience in the job offered or in an Analytical Development Scientist-related occupation.
• Alternatively, employer will accept a Ph.D. degree, or foreign equivalent, in Pharmacology or a related field and 2 years of experience in the job offered or in an Analytical Development Scientist-related occupation.
• Position requires demonstrable experience in the following: Reliable and consistent technical skills on relevant Cell therapy analytical assay platforms including: Capsid Enzyme-linked immunosorbent assay (ELISA), AlphaLISA and Western blotting techniques FlowCAM analysis Optical Coherence Tomography Islet Perifusion system Droplet digital polymerase chain reaction (ddPCR) and qPCR for copy number variation Flow Cytometry hESC expansion and Cell culture, and o Cell-based potency assays.
• Theoretical and practical knowledge of developing characterization assay including cell counting assays for cells encapsulated in immunoprotected device.
• Experience with developing and qualifying functional potency assays including glucose stimulated insulin secretion assay for beta cells encapsulated in immunoprotected device.
• Experience with expansion and differentiation of hESCs to beta cell islets and experience with culturing multiple mammalian cell lines.
• Technical knowledge of IND enabling GLP animal toxicology study.
• In-depth knowledge of commercial biological assay development, validation, transfer, and troubleshooting compliant with GMP operations, supporting product development and Commercialization.
• Knowledge of spent media analysis using platforms including Flex2, Rebel, and Cedex.
• Technical knowledge of IND and BLA filing documents for cell therapy-based drug products.
• Contributing to CMC strategy for regulatory filing for late phase drug development.
• Effectively collaborate with an integrated cross-functional team to perform tech transfers, root cause analysis studies and training runs.
• Provide analytical oversight for CDMO, CRO, CTO, and third-party testing to support commercial manufacturing (In-Process Controls and release).

Responsibilities

• Lead design and execution of analytical procedures that support development of cell therapy products.
• Develop, qualify and validate new test methods for characterization, purity and potency of hESCs and iPSC derived cell intermediates and drug products.
• Rapidly incorporate and adapt longstanding methods to the most recent FDA guidelines.
• Generate hypotheses and creative solutions to pursue Project goals, set new experimental directions, and overcome obstacles.
• Establish assay design criteria using Design of Experiments (DOE) and other contemporary development tools.
• Successfully transfer complex cell-based assays to QC and provide SME support for qualification and validation, including authoring and reviewing of protocols and reports.
• Develop and manage analytical commercial capabilities and strategies to ensure robust and compliant analytical methods and testing for commercial requirements.
• Provide technical recommendations broadly within the company regarding own field and play a key Project Role.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees