Vertex Pharmaceuticals
External Manufacturing Operations Gene Editing Associate Director
Vertex Pharmaceuticals, Boston, Massachusetts, us, 02298
Overview
The primary focus of the Associate Director External Manufacturing role is to oversee Vertex’s critical cell and gene therapy CDMOs and implement our vision for this business-critical function. We are looking for a candidate with the breadth of professional experience and the drive to work with both internal and external partners to define and manage the ongoing cGMP supply of cell and gene therapy products from clinical through post-approval lifecycle management. The successful candidate should have a strong operational, quality, compliance and technical background, with proven project management and supplier management abilities, and will be a key member of the Vertex/CDMO Virtual Plant Team (VPT) contributing to broader External Manufacturing group activities. Key Duties And Responsibilities
Developing strong relationships with internal functional leaders, leveraging these relationships for development and alignment of the program objectives Building and maintaining strategic and operational relationships with Vertex CMOs Identifying and escalating business-critical issues affecting supply and timelines as necessary, providing recommendations, mitigations and potential solutions Managing cross-functional teams, building into a high-functioning team where team members are accountable as both functional as well as program representatives Driving delivery of the program objectives against aggressive timelines, including managing risks and issues that arise Managing and coordinating post-approval lifecycle strategy implementation for programs, including establishing a robust business continuity program with strategic CMOs Function as the first/primary point of contact for all Vertex interests/activities at certain ATMP cell and gene therapy CDMOs Provide operational oversight of, and troubleshooting support to, CDMOs to ensure all deliverables meet or exceed Vertex requirements Maintain on-site presence at certain CDMO facilities for extended periods (including some off-hours/days to resolve urgent issues) during clinical batch manufacturing, Health Authority inspections and other critical activities Liaison with internal and CDMO stakeholders and leadership on business operations including contract management, forecast communication, compliance and finance Leverage Technical, Quality and Regulatory SMEs to provide guidance to CDMOs and ensure cross-functional alignment on program priorities and deliverables from clinical through commercial manufacturing and supply Manage and track CDMO performance prior to, during and after manufacturing Manage and track batch data in compliant systems to support filing submissions, patient planning and process optimization Work with CDMO and internal Quality and Technical teams to prioritize and track documentation (change controls, investigations, deviations) to meet Vertex program requirements Collaborate with CDMO and internal stakeholders to implement planned changes including change controls and impact assessments Facilitate data collation to track CDMO performance and compliance on metrics/KPIs including contractual agreements, batch release, spend/budget, product quality and supply integrity Identify and escalate business-critical issues to Commercial Manufacturing and Supply Chain and Quality leadership Lead continuous improvement initiatives to resolve supply issues in a timely manner Build and maintain strategic relationships within the CDMO organization and with internal stakeholders Live the Vertex values Flexibility to work shift hours to cover critical process steps; ability to travel national and international up to 30% Represent Vertex as a leader when issues arise Knowledge And Skills
Strong quality and compliance background in a commercial GMP biopharmaceutical operations environment; sound working knowledge of health authority regulations Strong technical background in aseptic manufacturing operations Solid project management skills and experience managing complex projects Strong verbal and written communication skills Strong leadership and ability to collaborate and build relationships Ability to work calmly and make sound decisions in a fast-moving environment Education And Experience
Bachelor's degree required, ideally in cell biology or related Life Sciences disciplines with 8+ years of relevant experience in biotech or pharmaceutical industries; ideally in a senior manufacturing leadership role in cGMP facilities MS/MA degree in Biological Sciences, Chemical Engineering or related discipline with at least 6 years of related experience Strong technical background in cell and genetic therapy manufacturing operations, ideally autologous cell therapy experience Experience in equipment and facility qualification and validation for ATMP CDMOs Pay Range
$154,400 - $231,600 Disclosure Statement
The range provided is based on 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 be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on factors including skills, competencies, experience, and other job-related factors permitted by law. Vertex also offers Total Rewards with benefits, including medical, dental, vision, PTO, educational assistance, commuting subsidy, 401(k) and more. Flex Designation
Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status
In this Hybrid-Eligible role, you can choose to be designated as Hybrid or On-Site. Note: Flex status subject to Vertex policy and may change. Company Information
Vertex is a global biotechnology company that invests in scientific innovation and is committed to equal employment opportunity and non-discrimination. Vertex is an E-Verify Employer in the United States. Reasonable accommodations are provided for qualified individuals with known disabilities in accordance with applicable law. If you require an accommodation in connection with the hiring process, please contact the recruiter or hiring manager, or Talent Acquisition at ApplicationAssistance@vrtx.com
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The primary focus of the Associate Director External Manufacturing role is to oversee Vertex’s critical cell and gene therapy CDMOs and implement our vision for this business-critical function. We are looking for a candidate with the breadth of professional experience and the drive to work with both internal and external partners to define and manage the ongoing cGMP supply of cell and gene therapy products from clinical through post-approval lifecycle management. The successful candidate should have a strong operational, quality, compliance and technical background, with proven project management and supplier management abilities, and will be a key member of the Vertex/CDMO Virtual Plant Team (VPT) contributing to broader External Manufacturing group activities. Key Duties And Responsibilities
Developing strong relationships with internal functional leaders, leveraging these relationships for development and alignment of the program objectives Building and maintaining strategic and operational relationships with Vertex CMOs Identifying and escalating business-critical issues affecting supply and timelines as necessary, providing recommendations, mitigations and potential solutions Managing cross-functional teams, building into a high-functioning team where team members are accountable as both functional as well as program representatives Driving delivery of the program objectives against aggressive timelines, including managing risks and issues that arise Managing and coordinating post-approval lifecycle strategy implementation for programs, including establishing a robust business continuity program with strategic CMOs Function as the first/primary point of contact for all Vertex interests/activities at certain ATMP cell and gene therapy CDMOs Provide operational oversight of, and troubleshooting support to, CDMOs to ensure all deliverables meet or exceed Vertex requirements Maintain on-site presence at certain CDMO facilities for extended periods (including some off-hours/days to resolve urgent issues) during clinical batch manufacturing, Health Authority inspections and other critical activities Liaison with internal and CDMO stakeholders and leadership on business operations including contract management, forecast communication, compliance and finance Leverage Technical, Quality and Regulatory SMEs to provide guidance to CDMOs and ensure cross-functional alignment on program priorities and deliverables from clinical through commercial manufacturing and supply Manage and track CDMO performance prior to, during and after manufacturing Manage and track batch data in compliant systems to support filing submissions, patient planning and process optimization Work with CDMO and internal Quality and Technical teams to prioritize and track documentation (change controls, investigations, deviations) to meet Vertex program requirements Collaborate with CDMO and internal stakeholders to implement planned changes including change controls and impact assessments Facilitate data collation to track CDMO performance and compliance on metrics/KPIs including contractual agreements, batch release, spend/budget, product quality and supply integrity Identify and escalate business-critical issues to Commercial Manufacturing and Supply Chain and Quality leadership Lead continuous improvement initiatives to resolve supply issues in a timely manner Build and maintain strategic relationships within the CDMO organization and with internal stakeholders Live the Vertex values Flexibility to work shift hours to cover critical process steps; ability to travel national and international up to 30% Represent Vertex as a leader when issues arise Knowledge And Skills
Strong quality and compliance background in a commercial GMP biopharmaceutical operations environment; sound working knowledge of health authority regulations Strong technical background in aseptic manufacturing operations Solid project management skills and experience managing complex projects Strong verbal and written communication skills Strong leadership and ability to collaborate and build relationships Ability to work calmly and make sound decisions in a fast-moving environment Education And Experience
Bachelor's degree required, ideally in cell biology or related Life Sciences disciplines with 8+ years of relevant experience in biotech or pharmaceutical industries; ideally in a senior manufacturing leadership role in cGMP facilities MS/MA degree in Biological Sciences, Chemical Engineering or related discipline with at least 6 years of related experience Strong technical background in cell and genetic therapy manufacturing operations, ideally autologous cell therapy experience Experience in equipment and facility qualification and validation for ATMP CDMOs Pay Range
$154,400 - $231,600 Disclosure Statement
The range provided is based on 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 be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on factors including skills, competencies, experience, and other job-related factors permitted by law. Vertex also offers Total Rewards with benefits, including medical, dental, vision, PTO, educational assistance, commuting subsidy, 401(k) and more. Flex Designation
Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status
In this Hybrid-Eligible role, you can choose to be designated as Hybrid or On-Site. Note: Flex status subject to Vertex policy and may change. Company Information
Vertex is a global biotechnology company that invests in scientific innovation and is committed to equal employment opportunity and non-discrimination. Vertex is an E-Verify Employer in the United States. Reasonable accommodations are provided for qualified individuals with known disabilities in accordance with applicable law. If you require an accommodation in connection with the hiring process, please contact the recruiter or hiring manager, or Talent Acquisition at ApplicationAssistance@vrtx.com
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