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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Pay Range:

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

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 Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

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