Analytical Development Scientist

Job Description

Employer: Vertex Pharmaceuticals Incorporated

JOB TITLE: Analytical Development Scientist

LOCATION: 316 - 318 Northern Avenue Boston Massachusetts 02210

OPENINGS: 1

DUTIES:

• 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 Masterss 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 -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).

Rate of Pay: $113464.00 - $132400.00

CONTACT: Send Resume to . Reference 12140.434. EOE.

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Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this On-Site designated role you will work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertexs Policy on Flex @ Vertex Program and may be changed at any time.

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Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry ethnicity disability veteran status genetic information sexual orientation marital status or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager or contact Talent Acquisition at