Job Description General Summary: We are seeking an experienced Associate Director, Aseptic Operations and Training – CGT to lead the Aseptic Operations and Training team within the Biopharmaceutical Sciences – Cell & Gene Therapy (CGT) Manufacturing and Process Engineering organization. This role is critical in building a high-performing team to support scalable clinical and commercial manufacturing across multiple Boston-area sites. The Associate Director will ensure compliance with global regulatory requirements, maintain audit-ready GMP facilities, and drive operational excellence in aseptic practices and training. This position reports to the Director, CGT Engineering Operations and is designated as on-site, based at LC1, Boston. Key
Duties
and
Responsibilities
Build, lead, and mentor the Aseptic Operations and Training team, fostering a culture of compliance and continuous improvement. Assess Manufacturing Operations and Support teams’ capabilities, address skill gaps, and align team goals with organizational and regulatory requirements. Develop and Deploy a GMP Manufacturing Training Strategy that builds upon competency-based training principles and eliminates read and understand training approaches, Responsible for the Training Lab Facility and training staff through which all GMP production personnel onboard and learn basic and advanced cell and gene therapy process and aseptic skills. Oversee Aseptic Process Simulation (APS) and Aseptic Personnel Qualification (APQ) programs to ensure compliance with CGT standards and applicable US and International Regulatory expectations. Act as SME for Contamination Control Strategies, GMP facility cleaning operations, material disinfection, sterilization, and cleaning validation processes. Develop, implement and manage the GMP training program to ensure personnel competency in manufacturing and aseptic operations. Lead initiatives to improve particulate control and prevention in single-use manufacturing systems. Accountable for effective, on-site, support of aseptic behaviors and training in GMP operations. Oversee regulatory compliance, inspection readiness, and serve as the primary contact for the GMP training strategy, program and performance during inspections. Collaborate with cross-functional teams to drive process improvements and implement best practices. Monitor industry trends in aseptic processing and cleaning technologies to ensure innovation. Track and manage key metrics and KPIs to drive operational efficiency and continuous improvement. Knowledge and Skills: Proven leadership in regulated environments with a focus on team development and operational excellence. Strong communication and interpersonal skills, including direct interaction with regulatory authorities related to aseptic controls and strategies Analytical problem-solving and strategic planning abilities. Adaptability and sound decision-making in dynamic environments. Strong knowledge of cGMP requirements for manufacturing Excellent planning and organizational skills, with the ability to balance production, development and continuous improvement needs.
Education
and
Experience
Bachelor’s degree in Engineering, Microbiology, Biotechnology, or related field; advanced degree preferred. 8 years of progressive experience in GMP manufacturing or process engineering leadership, with at least 5 years of aseptic operations and training in CGT, Biologics, or Sterile filling operations. Expertise in drug product manufacturing, APS, APQ, GMP cleaning operations, and sterilization/cleaning validation and complying with Annex 1 requirements in GMP manufacturing.
Experience
managing GMP training programs, driving continuous improvement, and implementing digital transformations. Proficiency in manufacturing systems (e.g., eBR, DCS/SCADA, Pi, ERP, QMS) and paperless execution strategies. Strong knowledge of regulatory requirements, including investigations, CAPA, change control, and risk mitigation.
Pay Range
$163,200 - $244,800 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: On-Site Designated 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. #LI-Onsite 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 Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.