Job Description
General Summary:
The Senior Director, Analytical Development is a senior leadership role within the Cell and Gene Therapy Analytical Development function and will be responsible for setting and driving the company’s analytical testing strategy, including manual and automated testing approaches, analytical operations, and implementation of automation capabilities. This leader will oversee teams focused on automation of assays, testing in support of process workstreams, and analytical operations such as reagent and assay control management.
The role will work closely with Manufacturing, Process Development, Regulatory, Quality, CMC, and external partners to generate high-quality data that informs strategy and decisions, while advancing next-generation analytical automation tools for characterization of cell, gene and biologic therapy processes and products. This position will also shape broader analytical strategy across multiple programs and build organizational capability through strong scientific and people leadership.
Key Duties and Responsibilities:
- Provide strategic leadership for the Testing, Operations, and Automation Analytical Development function across multiple programs
- Establish and drive testing strategies using manual and automated methods to support process development, process characterization, and stability studies to build process/product understanding and inform control strategies (~70% of team resources)
- Lead and oversee teams responsible for the development, optimization, and qualification of automated and PAT analytical methods and end-to-end automation platforms for process development and analytics (~20% of team resources)
- Lead the establishment of laboratory informatics for highly automated equipment and digitization projects supporting data trending and visualization platforms that support interpretation of analytical datasets, including AI and machine learning tools. (~5% of team resources)
- Establish and manage critical assay reagents, assay controls, and control charts to ensure optimal assay performance (~5% of team resources)
- Set and reinforce operational best practices across analytical development, including sample management, data management, data integrity, documentation in notebooks and reports, and training
- Build strong cross-functional and external partnerships to advance analytical and program goals
- Author and review technical and scientific documents, including presentations, study protocols, reports, and test methods
- Recruit, mentor, and develop organizational talent while managing department resources, budget, and headcount
Knowledge and Skills:
- Extensive experience establishing and leading analytical testing teams, including establishment of testing strategies that include manual and automated methods
- In-depth experience and aptitude in laboratory informatics and implementation of AI/machine learning tools for laboratory automation, partnering with Digital/IT functions
- In-depth experience with automation of analytical method development, optimization, and qualification and end-to-end automation platforms supporting process development and analytics
- In-depth experience with digitization projects including data trending and visualization platforms to support interpretation of datasets
- Knowledge of product characterization testing and analytical procedure implementation. Experience supporting PAT method development, process development, process characterization, and stability studies
- Expertise in sample management, data management, and data integrity practices
- Experience managing critical assay reagents, assay controls, and control charts
- Strong understanding of ICH, FDA, and USP guidelines, and ability to apply them in the context of pharmaceutical development stage
- Experience authoring and reviewing study protocols, reports, test methods, and regulatory-supporting documentation
The following capabilities are especially important for success in this role:
- Self-driven and recognized as a laboratory digitization champion
- Proven track record of people leadership and managing high throughput testing
- Ability to lead in a fast-paced environment, manage competing priorities, and maintain timelines across multiple activities
- Strong scientific depth within one’s discipline, with a broad understanding of adjacent scientific disciplines and the drug development process
- Excellent written, verbal, interpersonal, and matrix leadership skills
- Ability to influence internal and external stakeholders and work effectively both independently and in team environments
- Scientific leadership marked by high ethical standards and broad peer respect
- Extensive experience establishing and leading analytical testing teams, including establishment of testing strategies that include manual and automated methods
Education and Experience:
- Masters degree or PhD in relevant discipline (analytical chemistry, immunology, biochemistry, cell biology, biotechnology or related field) with progressive experience in technical leadership roles in the pharmaceutical industry. Experience with Cell Therapy, Biologics, and Genetic therapies is critical
- Ph.D. (or equivalent degree) and 11+ years of relevant post-doctoral employment experience, or
- Masters Degree (or equivalent degree) and 15+ years of relevant employment experience
Pay Range:
$226,100 - $339,100Disclosure 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:
On-Site DesignatedFlex 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.
#LI-Onsite
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 [email protected]
Skills Required
- Master’s degree or PhD in analytical chemistry, immunology, biochemistry, cell biology, biotechnology, or a related discipline
- PhD or equivalent degree with 11+ years of relevant post-doctoral employment experience
- Master’s degree or equivalent with 15+ years of relevant employment experience
- Progressive technical leadership experience in the pharmaceutical industry
- Critical experience with cell therapy, biologics, and genetic therapies
- Extensive experience establishing and leading analytical testing teams
- Experience developing testing strategies using manual and automated methods
- In-depth laboratory informatics experience and implementation of AI and machine learning tools for laboratory automation
- Experience automating analytical method development, optimization, qualification, and end-to-end analytical platforms
- Experience with digitization, data trending, and data visualization projects
- Knowledge of product characterization testing, analytical procedure implementation, PAT method development, process development, process characterization, and stability studies
- Expertise in sample management, data management, and data integrity practices
- Experience managing critical assay reagents, assay controls, and control charts
- Strong understanding of ICH, FDA, and USP guidelines
- Experience authoring and reviewing study protocols, reports, test methods, and regulatory-supporting documentation
- Proven people leadership experience and experience managing high-throughput testing
- Excellent written, verbal, interpersonal, and matrix leadership skills
Vertex Pharmaceuticals Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Vertex Pharmaceuticals and has not been reviewed or approved by Vertex Pharmaceuticals.
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Parental & Family Support — Policies provide 12 weeks of 100% paid bonding leave for all U.S. parents with additional fully paid time for birth parents. Family-forming supports include adoption and surrogacy assistance, fertility options like IVF and egg cryopreservation, breast‑milk shipping, subsidized childcare, backup care, and a DCFSA match.
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Leave & Time Off Breadth — Time off includes roughly four weeks of vacation, 13 holidays, sick time, and two companywide shutdowns (summer and year‑end). Some roles also include flexible or unlimited time off and paid volunteer time.
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Retirement Support — Programs include a 401(k) plan with employer contributions and an employee stock purchase plan. Filings describe employer contributions occurring in company stock, supporting long‑term ownership.
Vertex Pharmaceuticals Insights
What We Do
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases. Founded in 1989 in Cambridge, Massachusetts, our corporate headquarters is now located in Boston’s Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 3,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development. Vertex is consistently recognized as one of the industry’s top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. Our research and medicines have also received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the French Prix Galien and the British Pharmacological Society awards.
