Principal Scientist, Aseptic Control MSAT Process

Job Description

General Summary:

The Principal Scientist Aseptic Control is recognized as having expertise in the principals and application of sterile and low bioburden processing technologies and providing technical support for manufacturing of cell and gene therapy (C&GT) small molecule and combination medical device programs within cCMP manufacturing. This aseptic processing SME will partner with stakeholders to define strategies for microbial control of activities such as gowning facility monitoring programs (EM Water Gases etc.) disinfectant efficacy aseptic processing simulations filtration particulate control risk assessments and will ensure the control strategies comply with industry guidance. The individual will interface with internal and external manufacturing sites to support the maintenance of critical cGMP aseptic activities and will also assist in significant manufacturing investigations involving aseptic and/or low bioburden processing and facility monitoring programs. This role will report to the Director of Aseptic Control within Manufacturing Science and Technology (MSAT) Process team for Biopharmaceutical Sciences and Manufacturing Operations (BSMO). This position will be based in Vertexs corporate headquarters in Boston MA (Hybrid eligible working arrangement where flexibility in on-site working is available).

The successful candidate will be experienced in the field of aseptic process technologies (drug product and drug substance) including simulations filter integrity microbial testing strategies microorganism characterization aseptic technique and clean room facility monitoring programs.

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.
• Strong collaboration in the resolution of manufacturing investigations related to aseptic control events
• Support the design and implementation of risk-based approaches and strategies designed to control bioburden and prevent contaminations for drug substance and drug product manufacturing sites.
• Support of regulatory submissions and pre-approval inspection activities related to contamination control and prevention and control strategies for aseptic operations.
• Work closely with colleagues in Process development to design and implement new technologies for aseptic filling of cell therapy drug products in novel device platforms; this includes working closely with Contract Development and Manufacturing Organizations (CDMOs) and engineering firms to design processes and equipment needed to perform aseptic filling operations in a GMP environment.
• Establish processes and capabilities to provide technical stewardship of control strategies post-approval including establishing performance monitoring capability and troubleshooting/ out of conformance event resolution. This will involve partnering closely with external contract manufacturing and testing organizations to establish processes to monitor test process performance and continuous improvement initiatives.
• Adherence to the culture of quality and ensure that all activities and documentation comply with regulatory requirements. Understand and implement processes controls and methods that align with global Health Authority regulatory expectations.
• Drive operational excellence flawless execution and continuous improvement.

Knowledge and Skills:

• At least 10 years of experience in an aseptic drug product technical role in process development and/or manufacturing for biologics and/or cell therapy products
• Demonstrated ability to implement industry-recognized best practices and risk-based approaches for sterility assurance and contamination control and prevention.
• Deep understanding of technical and operational aspects of late phase to commercial GMP aseptically processed drug substance and drug product manufacturing regulations and excellent written and verbal communication skills.
• Prior experience supporting drug product manufacturing activities across multiple modalities (e.g. sterile dosage form devices etc.) and design of sterility assurance and facility monitoring programs is desired.
• Experience with root cause analysis and deviation management
• A strategic thinker with strong result-orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner
• Excellent communication and interpersonal skills with the ability to build strong cross-functional relationships and communicate complex issues and concepts enterprise-wide
• Problem solver with a hands-on approach and ability to anticipate adverse scenarios and provide contingency plans to address them
• Keeps current on professional knowledge expertise and best practice; influential in the external environment in the area of aseptic processing and participates in industry consortia/ conferences relevant to the field.

Education and Experience:

• Degree in biological (microbiology preference) and/or engineering disciplines
• At least 8 years of relevant experience in biotech or pharmaceutical industries ideally in a technical leadership role in a cGMP facility

At Vertex we embrace continuous learning and encourage employees to stay informed on advances in AI technology automation and industry trends. We seek talent who bring an external perspective demonstrate curiosity and sound judgment and thoughtfully adopt new capabilities that improve decision-making drive innovation increase efficiency and help deliver better outcomes for patients.

Pay Range:

$145500 - $218300

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 Vertexs 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 persons 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

Required Experience:

Staff IC