Aseptic Control Principal Scientist, MSAT

Job Description A senior technical leader who brings deep expertise in the principles and application of aseptic and low bioburden processing technologies to support manufacturing of cell and gene therapy (C>), small molecule, and combination medical device programs. The role provides technical support across the entire cCMP manufacturing portfolio, partnering with stakeholders to define strategies for microbial control of gowning, facility monitoring programs (EM, Water, Gases, etc.), disinfectant efficacy, aseptic processing simulations, filtration, particulate control, risk assessments, and ensuring compliance with industry guidance. The incumbent interfaces with internal and external manufacturing sites to maintain critical cGMP aseptic activities, conducts investigations of aseptic and low bioburden incidents, and reports to the Director of Aseptic Control within MSAT Process team. General Summary The Principal Scientist engages cross‑functionally with colleagues in BSMO/CMSC, Regulatory, Quality and R&D to design and implement technologies that enable aseptic and low bioburden drug product and drug substance manufacturing, risk‑based design, and regulatory submissions. The position supports the implementation of risk‑based design and controls for low bioburden process operations and maintains stewardship of control strategies post‑approval. Key Duties and Responsibilities Provide technical input into environmental/facility/process monitoring program deviations and contamination events to determine impact to batch disposition and design/implement effective corrective and preventative actions to prevent future disruptions. Collaborate in the resolution of manufacturing investigations related to aseptic control events. Support the design and implementation of risk‑based approaches to control bioburden and prevent contaminations for drug substance and drug product manufacturing sites. Assist in regulatory submissions and pre‑approval inspection activities related to contamination control and prevention and control strategies for aseptic operations. Work closely with Process Development to design and implement new technologies for aseptic filling of cell therapy drug products, collaborating with CDMOs and engineering firms to execute in a GMP environment. Establish processes and capabilities to provide technical stewardship of control strategies post‑approval, including performance monitoring and troubleshooting/out‑of‑conformance event resolution in partnership with external contract manufacturing and testing organizations. Ensure activities and documentation comply with regulatory requirements and align with global Health Authority expectations. Drive operational excellence, flawless execution, and continuous improvement. Knowledge and Skills 10+ years of aseptic drug product technical experience in process development and/or manufacturing for biologics and/or cell therapy products, with a proven record of implementing industry best practices and risk‑based sterility assurance. Deep understanding of late‑phase to commercial GMP aseptic manufacturing regulations and excellent written and verbal communication skills; experience across multiple modalities and design of sterility assurance and facility monitoring programs is desired. Experience with root cause analysis and deviation management. Strong cross‑team collaboration skills and ability to build relationships and partnerships. Comprehensive knowledge of commercial manufacturing operations, testing, controls, and regulatory governance. Strong understanding of cGMP requirements. Strategic thinker with result orientation and sense of urgency to deliver quality results on time. Excellent communication and interpersonal skills for enterprise‑wide complex issue communication. Team player who sustains organization respect and trust at all levels. Problem solver with a hands‑on approach, anticipating adverse scenarios and providing contingency plans. Resilient and adaptable to a fast‑paced entrepreneurial environment. Sound judgment and business acumen with flexibility as the business and team evolve. Takes initiative to stay current on professional knowledge, best practices, and industry participation. Education and Experience Advanced degree (PhD or equivalent) in biology (microbiology preferred) and/or engineering disciplines with at least 8 years of relevant experience in biotech or pharmaceutical industries, ideally in a technical leadership role in a cGMP facility. Pay Range $145,500 - $218,300 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 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 At Vertex, our Total Rewards offerings include inclusive market‑leading benefits to meet employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. Benefits include medical, dental and vision, 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: Hybrid : work remotely up to two days per week; or select On-Site : work five days per week on‑site with ad hoc flexibility. #LI-Hybrid EEO Statement 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 View email address on click.appcast.io #J-18808-Ljbffr Dormont Manufacturing Co