Analytical Science and Technology Scientist (Contract)

Job Summary:

This Scientist position will be part of Analytical Sciences and Technology (ASAT) team. S/He/They will provide expertise in analytical assay life cycle management including method validations and transfers, quality event investigations, regulatory filings, and other activities to support the commercial manufacturing and critical component release for late stage and commercial programs in the Cell and Gene Therapy (CGT) portfolio.

Hybrid 3 days on site and 2 remote

12 month contract with chance to extend

Key Responsibilities:

• Work independently or in collaboration with internal and/or external partners in analytical lifecycle management activities including method validation and method transfer
• Author and/or review technical documents, including method SOP, study protocol, technical report, and other regulatory agency facing documents
• Be a key Subject Matter Expertise (SME) and represent ASAT to participate in troubleshooting and/or quality event remediation during release and/or stability testing
• Provide SME assessment for deviation, CAPA and change control
• Perform data trending analysis
• Perform in-lab experiments as applicable

Knowledge and Skills:

Must Have

• Knowledge of relevant ICH and regulatory guidelines and good understanding of GMP concepts
• Protein and/or Oligo Mass Spectrometry experience
• Experience with Reference Standard life cycle management strongly preferred
• Excellent technical writing skills
• In-depth knowledge of analytical chemistry/biochemistry/molecular biology techniques including HPLC, UPLC, and/or flow cytometry
• Partners effectively with internal and external functions, including contract testing organizations

It is desirable to have

• Experience in gene and/or cell therapy and/or CRISPR gene editing
• Experience with analytical support for late-stage or commercial biological products and cGMP manufacturing
• Experience with critical reagent management
• Experience of using JMP or similar statistical tools is a plus
• Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and efficiency

Education and Experience:

BS or above in Biology, Biochemistry, Analytical Chemistry and related fields.

Minimum 8 years of experience in the pharmaceutical/biopharmaceutical industry or the equivalent combination of education and experience.

$50-$53

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

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No C2C or Third-Party Vendors