Associate Director, Bioanalytical

Job Description

General Summary:

Associate Director with extensive experience in bioanalysis for cell and gene therapies and proficient knowledge with BA-related regulatory guidance. As a member of the DMPK-Bioanalysis organization, this person will be responsible for method development/qualification of molecular and protein bioanalysis, devising scientific and regulatory strategies, managing a group of junior scientists, and preparation of high-quality reports and presentations.

Key Duties and Responsibilities:

• Design and perform bioanalytical assay development, including quantitation of DNA/RNA and immunogenicity evaluations for cell and gene therapies

• Supervise junior scientists by providing scientific and technical leadership to bioanalytical assay development/qualification and analysis of study samples

• Evaluate novel platforms or technologies to enhance DMPK-Bioanalysis capabilities

• Collaborate with cross functional teams to design and execute bioanalytical studies

• Responsible for conducting or supervising internal and external bioanalytical assays in support of preclinical and clinical studies, and ensure alignment with industry standard practice and regulatory expectations

Knowledge and Skills:

• Hand-on technical experience in bioanalytical assay development, validation and sample analysis, including (but not limited to) PCR, RT-PCR, bDNA, LBA, ELISPOT etc spanning from Research to Development phases

• Proficient knowledge and experience of bioanalytical assay requirements and submission standards per regulatory guidelines

• Excellent organizational skills and documentation practices

• Excellent communication skills with ability to build open and collaborative relationships and work effectively as a member of multidisciplinary teams

• Experience with working in a collaborative team environment and with CROs to oversee assay transfer, troubleshooting, assay development/validation and sample testing

• Previous work experience in GLP environment is a plus

Education and Experience:

• Master's (M.S) degree in biochemistry, cell biology, or related discipline with 8+ years working experience in biotech or pharmaceutical industry or,
• PhD degree with 6+ years working experience in a related discipline

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Flex Designation:

Flex Eligibility Status:

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 person's 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 ApplicationAssistance@vrtx.com