Job Description

General Summary:

This critical senior position is responsible for leading the Commercial Quality Control team within the Commercial Manufacturing and Supply Chain Division. The incumbent will be responsible for leading a diverse team that is responsible for executing release and stability testing of all commercial programs across multiple modalities including small molecules, Cell and Genetic Therapies and Biologics. As well as leading established teams and platforms, the leader will be responsible for building new capabilities required for emerging pipeline assets and supporting routine manufacturing operations to ensure timely and quality products are delivered to patients.

The team will be responsible for building a scalable QC network, heavily leveraging external testing capabilities and Contract manufacturing and testing organizations to test products and raw materials. The team will lead the development and implementation of robust, complaint and efficient business processes to enable manufacturing and product disposition. The head of this group will also cultivate and leverage multiple cross-functional business relationships to identify and execute creative solutions to organizational opportunities and challenges.

Key Duties and Responsibilities:

• Responsible for building a comprehensive external network of commercial QC testing capabilities that are in line with the business needs to support reliable supply of high-quality medicines to patients. The team will support diligence exercises to identify new testing sites and be responsible for bringing new testing sites into the QC network for all commercial programs. The team will be responsible for building logistics and scheduling capabilities to ensure that all samples are shipped and tested to support business needs in a timely and reliable manner. This may also include establishing internal laboratory capabilities to support routine testing and investigations.

• Build a high performing team by recruiting and developing strong talent, ensuring the development and implementation of training required to fully qualify staff for establishing and maintaining capable and controlled processes. Lead and develop a strong winning culture, fostering teamwork and commitment to excellence through transparent communication and staff engagement. Ensure the correct capabilities, resources and teams are built and in place to meet the needs of the business.

• This individual will be responsible for building and maintaining relationships with external contract testing labs used for commercial QC testing of drug substance/drug product batches, critical components and raw materials. This includes negotiating business terms with suppliers to ensure that Vertex’s goals are met, and interests are maintained to the highest standards. The individual will design and lead a fit-for-purpose governance structure with the suppliers to appropriately monitor performance and build long-term strategic capabilities and capacity to meet the needs of the business.

• This individual will work closely with the supply chain team to continually assess manufacturing capacity to ensure sufficient analytical capacity is established at the contract testing labs to support the testing needs of each commercial program.

• The team will be responsible for ensuring that final product testing is conducted in a robust and complaint manner at CTOs and that Certificates of analysis are issued in a timely manner to support timely disposition. The team will work closely with the External Manufacturing teams on logistics as well is issue resolution to support batch disposition decisions. Work closely with the Quality Assurance (QA) organization to ensure all processes are compliant.

• The team is responsible for managing OOS investigations at the contract testing labs and supporting the MSAT function during manufacturing investigations, to ensure investigations are closed out in a timely and compliant manner.

• This individual will be responsible for establishing both the long-range plan and annual budget to help ensure adequate analytical testing capacity is funded to support all commercial programs.

• The team will be responsible for raw material testing programs to support manufacturing operations, including test site identification and technical support and raw material and vendor qualification programs. This includes testing and qualification of complex critical components/ starting materials (eg vectors, cell banks, enzymes, nucleic acids) used for manufacture of complex call

• Work closely with the Analytical Sciences and Technology organization to implement comprehensive analytical method performance monitoring capabilities for all commercial programs. The team will be responsible for ensuring all data at the testing labs is made available to ensure monitoring is efficient and compliant.

• Champion the culture of quality and ensure that all activities and documentation comply with regulatory requirements. Team will be responsible for supporting audits and inspections at testing sites. Understand and implement processes, controls, and methods that align with global Health Authority regulatory expectations. Drive operational excellence, flawless execution and continuous improvement.

Knowledge and Skills:

• 12+ years progressive experience in a key leadership role in pharmaceutical development and commercial manufacturing and/or quality control. Experience with Biological products, Genetic and Cell Therapy technologies is critical

• Deep understanding of analytical method development and quality control that support commercial manufacturing activities; prior experience in method development used for cellular/ genetic therapies advantageous. The candidate must have a strong understanding of GMPs, and quality systems associated with analytical testing and quality control.

• A proven ability to work seamlessly across teams and develop excellent relationship and partnerships with peers is critical to success in this role.

• Demonstrated understanding of the principles and applications associated with commercial manufacturing operations for biological, cellular, and genetic therapies.

• A strategic thinker with strong result-orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner

• Strong understanding of the technical aspects of manufacturing, testing, and controls and regulations governing pharmaceutical operations

• Motivational leadership of a cohesive high-performing team within a global, highly matrixed environment; the ability to articulate vision and successfully drive execution

• Excellent communication and interpersonal skills with the ability to build strong cross-functional relationships and communicate complex issues and concepts enterprise-wide

• Excellent team player and be able to build and sustain organization respect and trust at all levels

• Problem solver with a hands-on approach and ability to anticipate adverse scenarios and provide contingency plans to address them

• Resilient and able to work well in a demanding, fast paced entrepreneurial environment

• Sound judgment and business acumen with personal versatility and flexibility as business and team evolve

• Keeps current on professional knowledge, expertise and best practice

Education and Experience:

• Advanced degree in biological or engineering disciplines with minimally 12 years of relevant experience in biotech or pharmaceutical industries, ideally in a leadership role in a cGMP facility within the biotechnology or pharmaceutical industry:

• MS/MA degree in Biological Sciences, Chemistry, microbiology or related discipline and at least 14 years of related experience; or PhD degree in Biological Sciences, Chemistry, microbiology or related discipline and at least 12 years of related experience

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