Vertex Pharmaceuticals

Vertex Pharmaceuticals

Mfg Operations Associate Director - Biologics, Drug Substance

Seattle, WA · Director

Sponsorship not specified$160k-$240kDetected 10 days ago
Project ManagementRecruitingGMPLeadershipCommunication

About the role

  • This role is responsible for ensuring processes are executed as intended and delivering reliable supply.
  • The Associate Director serves as the technical leader for manufacturing execution, driving performance, standardization, and rapid issue resolution across programs and CDMOs.

Responsibilities

  • Provide technical leadership for drug substance manufacturing campaigns at external partners, serving as the senior technical decision-maker during active operations to ensure consistent, compliant, on-time execution and strong campaign readiness
  • Lead cross-functional coordination across MSAT, Quality, and manufacturing teams, escalating and framing complex issues as needed
  • Own process operability and execution robustness at the manufacturing site, including batch record clarity and usability
  • Drive improvements in yield, cycle time, right-first-time performance, and overall manufacturing reliability
  • Lead campaign readiness, including implementation of CAPAs and process updates
  • Oversee real-time monitoring of batch and campaign performance, identifying risks, process drift, or execution gaps and drive timely technical interventions as needed to maintain schedule adherence, quality, and supply reliability
  • Build and strengthen Technical Services capability within biologics, including defining ways of working and developing technical staff
  • Drive a culture of accountability, urgency, and operational rigor
  • The Associate Director, Technical Services is accountable for the technical execution of biologics drug substance manufacturing at external manufacturing partners.
  • The Associate Director, Technical Services role is a key member of Vertex's External Manufacturing Organization (ExM), providing support, strategic insights and enterprise thinking to the Biopharmaceutical Sciences and Manufacturing Operations organization (BSMO).

Nice to have

  • BS/BA degree in Biological Sciences, Chemical Engineering, Chemistry or related discipline
  • advanced degree preferred
  • Requires 10+ years of experience in biologics manufacturing, MSAT, or external manufacturing
  • Experience with deviation management, investigations, and real-time technical troubleshooting in a cGMP environment
  • Previous leadership experience, including leading technical teams or cross-functional initiatives, preferred
  • Requires progressive experience in a management/leadership role in the biotechnology/ pharmaceutical industry with a focus on external manufacturing and commercial operations
  • Excellent communication and interpersonal skills, with the ability to influence cross-functional stakeholders and present insights to all levels of senior stakeholders
  • Demonstrated continuous improvement mindset, driving efficiencies, process improvements across diverse initiative

Skills

  • Deep understanding of biologics drug substance manufacturing processes and cGMP operations
  • Ability to identify and resolve technical issues quickly in a live manufacturing environment
  • Working knowledge of batch records, investigations, change control, and quality systems
  • Proven ability to operate effectively in a matrixed environment, coordinating across MSAT, Quality, and manufacturing teams
  • Demonstrated focus on execution, accountability, and operational rigor
  • Strong technical background in aseptic manufacturing operations.
  • Solid project management skills and experience managing complex projects.
  • Ability to work calmly and make sound decisions in a fast-moving environment of uncertainty and change
  • Flexibility to work shift hours required to cover critical process steps
  • Ability to travel, national and international, up to 30%
  • Strong verbal and written communication
  • ability to expresses oneself clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience.

Compensation

  • $160,000 - $240,000
  • 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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