Vertex Pharmaceuticals
CMC Product Leader, Senior Director - Biologics
Vertex Pharmaceuticals, Boston, Massachusetts, us, 02298
Overview
The Senior Director, CMC Product Leader, Biologics, will lead CMC functional teams of one or multiple biologics products. This role involves managing all CMC-related activities, ensuring the development, scale-up, and commercialization of high-quality biologics products. The successful candidate will be an integral part of the Product Team (PT), which operates as a sub-team of the Disease Strategy Team (DST). This position requires strong expertise in biologics process development, manufacturing, regulatory compliance, and cross-functional collaboration to drive product success. The individual will report into the Executive Director, Project Management and Strategic Operations for Biopharmaceutical Sciences-CGT. This role is based at Vertex’s Leiden Center location in Boston, MA and will be a hybrid eligible role with a minimum of three days onsite.
Key Responsibilities
CMC Leadership:
Develop and implement CMC strategies specific to biological products. Lead the CMC functional team (FT), overseeing process, method, and device development, scale-up, technology transfer, and validation. Ensure alignment of CMC activities with overall product development and commercialization goals.
Product Team (PT) Participation:
Serve as a key member of the Product Team (PT), contributing to cross-functional planning and decision-making. Collaborate with clinical, regulatory, commercial, and quality teams to achieve product milestones. Provide CMC expertise and insights to support strategic product decisions within the PT.
Process Development and Manufacturing:
Oversee the development and optimization of manufacturing processes to ensure product quality, consistency, and scalability, by partnering with internal CMC FT members from BiopharmSci and CDMO partners. Manage technology transfer to or between CDMO manufacturing sites, ensuring seamless scale-up and production readiness. Ensure GMP and other regulatory standards compliance.
Regulatory Compliance and Quality Assurance:
Develop CMC regulatory strategies and lead the preparation of CMC sections for regulatory submissions. Collaborate with regulatory affairs to address CMC-related queries and inspections. Implement robust quality control and assurance systems to maintain product integrity and compliance.
Cross-Functional Collaboration:
Ensure project and decision approval processes through BSMO and Vertex governance committees. Work with R&D, clinical, regulatory, and commercial teams to ensure cohesive product development. Facilitate communication and alignment between CMC activities and broader product development objectives. Lead internal cross-functional CMC teams and joint project teams with CDMOs, ensuring clear communication of progress, challenges, and needs.
Financial and Project Management:
Develop budgets for project CMC activities with BiopharmSci and Finance, track KPIs and milestones, and identify/mitigate risks to ensure timely and successful development and commercialization.
Qualifications
Advanced degree in Chemical Engineering, Biotechnology, Biochemistry, or related field; PhD or MBA preferred.
Minimum of 10 years of experience in CMC development and manufacturing within the biotechnology or pharmaceutical industry, focusing on biologics.
Experience leading a function or department in Process Development, Analytical Development, or Manufacturing at Director or Senior Director level preferred.
Proven track record of successful CMC development and commercialization of biologics products.
In-depth knowledge of GMP regulations, quality assurance, and regulatory requirements for biologics.
Experience managing external biologics process development/manufacturing with CDMOs preferred.
Strong strategic thinking, problem-solving, leadership, and cross-functional collaboration skills.
Experience with regulatory submissions and interactions with regulatory agencies.
Pay Range $237,700 - $356,600
Disclosure Statement The range provided is based on a reasonable estimate for the base salary at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may be eligible for overtime pay, per federal and state requirements. Actual base salary will be based on skills, experience, and other factors permitted by law. Vertex offers comprehensive benefits and Total Rewards programs, including medical, dental, vision, paid time off, educational assistance, commuter benefits, 401(k), and more.
Flex Designation and Eligibility Hybrid-Eligible or On-Site Eligible. In this Hybrid-Eligible role, you can choose to be designated as Hybrid (remote up to two days per week) or On-Site (five days per week with ad hoc flexibility). Flex status is subject to Vertex policy and may change.
Company Information Vertex is a global biotechnology company focused on scientific innovation. Vertex is an equal employment opportunity employer and adheres to applicable laws. Vertex is an E-Verify Employer in the United States and will provide reasonable accommodations for qualified individuals with known disabilities as required by law.
Additional Information Job-related notes: Seniority level - Director; Employment type - Full-time; Job functions include Product Management, Manufacturing, and Project Management; Industries include Biotechnology Research and Pharmaceutical Manufacturing.
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The Senior Director, CMC Product Leader, Biologics, will lead CMC functional teams of one or multiple biologics products. This role involves managing all CMC-related activities, ensuring the development, scale-up, and commercialization of high-quality biologics products. The successful candidate will be an integral part of the Product Team (PT), which operates as a sub-team of the Disease Strategy Team (DST). This position requires strong expertise in biologics process development, manufacturing, regulatory compliance, and cross-functional collaboration to drive product success. The individual will report into the Executive Director, Project Management and Strategic Operations for Biopharmaceutical Sciences-CGT. This role is based at Vertex’s Leiden Center location in Boston, MA and will be a hybrid eligible role with a minimum of three days onsite.
Key Responsibilities
CMC Leadership:
Develop and implement CMC strategies specific to biological products. Lead the CMC functional team (FT), overseeing process, method, and device development, scale-up, technology transfer, and validation. Ensure alignment of CMC activities with overall product development and commercialization goals.
Product Team (PT) Participation:
Serve as a key member of the Product Team (PT), contributing to cross-functional planning and decision-making. Collaborate with clinical, regulatory, commercial, and quality teams to achieve product milestones. Provide CMC expertise and insights to support strategic product decisions within the PT.
Process Development and Manufacturing:
Oversee the development and optimization of manufacturing processes to ensure product quality, consistency, and scalability, by partnering with internal CMC FT members from BiopharmSci and CDMO partners. Manage technology transfer to or between CDMO manufacturing sites, ensuring seamless scale-up and production readiness. Ensure GMP and other regulatory standards compliance.
Regulatory Compliance and Quality Assurance:
Develop CMC regulatory strategies and lead the preparation of CMC sections for regulatory submissions. Collaborate with regulatory affairs to address CMC-related queries and inspections. Implement robust quality control and assurance systems to maintain product integrity and compliance.
Cross-Functional Collaboration:
Ensure project and decision approval processes through BSMO and Vertex governance committees. Work with R&D, clinical, regulatory, and commercial teams to ensure cohesive product development. Facilitate communication and alignment between CMC activities and broader product development objectives. Lead internal cross-functional CMC teams and joint project teams with CDMOs, ensuring clear communication of progress, challenges, and needs.
Financial and Project Management:
Develop budgets for project CMC activities with BiopharmSci and Finance, track KPIs and milestones, and identify/mitigate risks to ensure timely and successful development and commercialization.
Qualifications
Advanced degree in Chemical Engineering, Biotechnology, Biochemistry, or related field; PhD or MBA preferred.
Minimum of 10 years of experience in CMC development and manufacturing within the biotechnology or pharmaceutical industry, focusing on biologics.
Experience leading a function or department in Process Development, Analytical Development, or Manufacturing at Director or Senior Director level preferred.
Proven track record of successful CMC development and commercialization of biologics products.
In-depth knowledge of GMP regulations, quality assurance, and regulatory requirements for biologics.
Experience managing external biologics process development/manufacturing with CDMOs preferred.
Strong strategic thinking, problem-solving, leadership, and cross-functional collaboration skills.
Experience with regulatory submissions and interactions with regulatory agencies.
Pay Range $237,700 - $356,600
Disclosure Statement The range provided is based on a reasonable estimate for the base salary at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may be eligible for overtime pay, per federal and state requirements. Actual base salary will be based on skills, experience, and other factors permitted by law. Vertex offers comprehensive benefits and Total Rewards programs, including medical, dental, vision, paid time off, educational assistance, commuter benefits, 401(k), and more.
Flex Designation and Eligibility Hybrid-Eligible or On-Site Eligible. In this Hybrid-Eligible role, you can choose to be designated as Hybrid (remote up to two days per week) or On-Site (five days per week with ad hoc flexibility). Flex status is subject to Vertex policy and may change.
Company Information Vertex is a global biotechnology company focused on scientific innovation. Vertex is an equal employment opportunity employer and adheres to applicable laws. Vertex is an E-Verify Employer in the United States and will provide reasonable accommodations for qualified individuals with known disabilities as required by law.
Additional Information Job-related notes: Seniority level - Director; Employment type - Full-time; Job functions include Product Management, Manufacturing, and Project Management; Industries include Biotechnology Research and Pharmaceutical Manufacturing.
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