Job Description General Summary The Senior Manager, Manufacturing Science & Technology (MS&T) – Drug Product Sterile Manufacturing provides technical leadership and lifecycle support for sterile drug product manufacturing processes across clinical and commercial programs. This role is accountable for process transfer, validation, continued process verification, deviation support, and continuous improvement for aseptic manufacturing, sterile filtration, filling, and associated unit operations. This individual partners cross‑functionally with Manufacturing, Quality, Regulatory, Supply Chain, Engineering, and external CMOs/CDMOs to ensure compliant, robust, and efficient sterile drug product operations throughout the product lifecycle. Key

Duties

and

Responsibilities

Technical Leadership Serve as the MS&T technical lead for sterile drug product manufacturing processes, including formulation and compounding, sterile filtration, aseptic filling, visual inspection, and packaging support as applicable. Provide scientific and engineering oversight to ensure process performance, robustness, and an appropriate control strategy. Lead troubleshooting of manufacturing issues and implement sustainable technical solutions. Process Transfer & Scale‑Up Lead technology transfer activities to internal manufacturing sites and external CMOs/CDMOs. Author and review technology transfer documentation, batch records, technical reports, and comparability assessments. Support scale‑up activities and ensure readiness for engineering, PPQ, and commercial manufacturing campaigns. Validation & Lifecycle Management Lead or oversee process validation strategies, PPQ execution support, and continued process verification activities. Support and/or lead hold‑time studies, mixing and filtration studies, and container closure integrity or compatibility assessments as required. Ensure sterile drug product processes remain in a validated state throughout the product lifecycle. Manufacturing Support Provide on‑the‑floor and remote MS&T support during manufacturing campaigns. Partner with Operations to improve yield, cycle time, batch success rate, and overall operational efficiency. Support deviation investigations, OOS/OOT events, CAPAs, and change controls using data‑driven and risk‑based approaches. Quality & Compliance Ensure all activities comply with cGMPs, regulatory expectations, and internal quality systems. Support regulatory filings and health authority inspections by authoring or reviewing technical sections and responding to questions. Collaborate closely with Quality Assurance to assess process impacts related to changes, deviations, and validation outcomes. Leadership & Cross‑Functional Collaboration Manage and develop MS&T scientists and engineers, as applicable. Provide mentoring, coaching, and technical guidance across the organization. Lead cross‑functional teams and influence stakeholders across Manufacturing, Quality, Process Development, Regulatory, and Supply Chain. Drive a culture of technical rigor, collaboration, and continuous improvement. Knowledge and Skills Deep technical expertise in sterile drug product manufacturing and aseptic processing. Strong problem‑solving, root cause analysis, and risk‑based decision‑making skills. Demonstrated experience supporting technology transfer, validation, and commercial manufacturing in a GMP environment.

Experience

with deviation investigations, CAPAs, change controls, and risk assessments. Strong leadership, project management, and stakeholder management capabilities. Excellent written and verbal communication skills.

Education

and

Experience

Bachelor’s degree in Chemical Engineering, Bioengineering, Pharmaceutical Sciences, Chemistry, Microbiology, or a related scientific or engineering discipline. 8+ years of experience in pharmaceutical or biopharmaceutical manufacturing, with significant experience in sterile drug product manufacturing. 3+ years of people management experience or equivalent experience leading complex cross‑functional initiatives. Advanced degree (MS, PhD, or PharmD) preferred.

Pay Range

$138,700 - $208,100 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: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: 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-Hybrid 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.