Vertex Pharmaceuticals

Vertex Pharmaceuticals

Director, Manufacturing Operations, Cell and Gene Therapy Operations

Boston, MA · Director

Sponsorship not specified$184k-$276kDetected 2 hours ago
Project ManagementNegotiationSupply ChainLogisticsRecruitingContract ManagementCustomer SupportGMPCRISPRMedical DevicesLeadershipCommunicationProcurement

About the role

  • The ideal candidate will understand the challenges and make proactive operational decisions, taking into consideration cross-functional and patient impact.
  • This role requires a strong operational, quality, compliance and technical background, with proven project management and supplier management abilities.
  • The successful candidate will be a key member of the Vertex/CMO Virtual Plant Team (VPT) contributing to the broader External Manufacturing group activities.

Responsibilities

  • Partner closely with internal stakeholders, providing leadership and guidance during development of the CMC, manufacturing and supply, logistics and commercialization strategies.
  • Manage Persons-in-Plant (PIPs) as needed to drive and oversee operational execution of the CMC, clinical and commercial plans at C(D)MOs.
  • Manage expectations by disciplined tracking of activities for delivery against objectives; managing changes (documentation, alignment); driving performance (metric setting, monitoring).
  • Coordinate, manage and co-lead C(D)MO governance meetings, in partnership with C(D)MO program manager and/or business lead.
  • Provide significant C(D)MO-focused regulatory filing input (IND, BLA, etc) and drive operations-focused pre-approval inspection and commercial readiness activities at the C(D)MO.
  • Create a strong winning culture, fostering teamwork and commitment to excellence through transparent communication and people engagement.
  • The Director-level role reflects the need for a strategic thinker who is able to negotiate difficult conversations with, and drive performance at, the CDMOs.

Requirements

  • Drive operational issue resolution, escalating appropriately to internal and/or joint governance if required.
  • As needed, partner with Strategic Sourcing for C(D)MO due diligence during new supplier selection to vet capabilities, risks and investments required.

Skills

  • Experience working in a biologics or CGT manufacturing plant highly preferred
  • Demonstrated experience as a primary leader in CDMO relationships
  • Demonstrated understanding of the development and management of contractual relationships for outsourced manufacturing operations
  • Problem solver with a hands-on approach and ability to anticipate adverse scenarios and provide contingency plans to address
  • Resilient and able to work well in a demanding, fast-paced and ambiguous 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
  • Able to travel, national and international, up to 50% of time during key periods of program activity
  • Education and Experience:
  • 10+ years progressive experience in key leadership/management roles in biologics or CGT therapy development, and clinical manufacturing.

Compensation

  • $184,000 - $276,000
  • 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.

Benefits

  • This role is eligible for an annual bonus and annual equity awards.

Company info

  • 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
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