Senior Director, Analytical Development, Testing and Lab Automation

Vertex Pharmaceuticals Inc (US); United States; On-site; USD 226,000 - 339,000; Full time

Job summary

Vertex Pharmaceuticals is seeking a Senior Director of Analytical Development to lead testing strategy, automation, and data-driven decision making for cell, gene, and biologic programs.

The role oversees automation platforms, laboratory informatics, and reagent controls, partnering with Manufacturing, Regulatory, Quality, and external partners to advance analytics while shaping strategy across programs.

Qualifications

• PhD or Masters with 11+ or 15+ years of relevant experience in pharma.
• Experience leading analytical development in cell/gene therapy preferred.
• Strong laboratory informatics and automation tool knowledge.

Responsibilities

• Provide strategic leadership for Testing, Operations, and Automation Analytical Development across programs.
• Establish and drive testing strategies using manual and automated methods for process development and stability studies.
• Lead teams for automated methods and end-to-end automation platforms for process development and analytics.
• Lead the establishment of laboratory informatics for highly automated equipment and digitization projects including AI/ML tools.
• Establish and manage critical assay reagents, controls, and control charts.
• Set and reinforce operational best practices across analytical development, data management, and training.
• Build cross-functional and external partnerships to advance goals.
• Author and review technical documents, study protocols, reports, and test methods.
• Recruit, mentor, and develop talent while managing budget and headcount.

Skills

Analytical development leadership

Automation in analytics

Laboratory informatics

AI/ML in lab automation

Regulatory knowledge (ICH FDA USP)

People leadership

Education

PhD in analytical chemistry / related field

Masters in analytical chemistry / related field

Job description

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

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Pay Range

$226,100 - $339,100 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

On-Site Designated 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.

#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 [e-mail] Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia, acute pain and acromegaly, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, congenital adrenal hyperplasia, ACTH-dependent Cushing's syndrome, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 16 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube, and X We believe our culture is one of Vertex's greatest strengths and a key enabler of our ability to deliver transformative medicines for patients who need them. Rooted in innovation, purpose and collaboration, our culture empowers people to take smart risks, challenge conventional thinking and do their best work. The diversity of our people is central to that culture. By bringing together individuals with different backgrounds, experiences and perspectives, we foster an environment where new ideas thrive, better decisions are made and breakthrough innovation is possible. We are committed to creating a workplace where everyone feels valued, included and connected to our shared mission, because we know that our unique culture and the collective strength of our people are what set Vertex apart.