Aseptic Control Principal Scientist, MSAT

Vertex Pharmaceuticals Inc (US); Boston (MA); Hybrid; USD 146,000 - 218,000; Full time

Benefits offered by this job

Medical/Dental/Vision

Paid time off

Educational assistance

Commuting subsidy

Charitable donations matching

401(k)

Job summary

Vertex Pharmaceuticals Inc. seeks a Principal Scientist in Aseptic Control based in Boston, MA. Hybrid eligible, you will lead aseptic processing strategies, monitor bioburden and contamination controls, and guide cross-functional teams across MSAT and BS...

to ensure compliant, high-quality manufacturing of cell and gene therapies and other modalities. You will bring 10+ years in aseptic drug product roles, strong regulatory and process development experience, and a strategic, results-driven

Qualifications

• Advanced degree (PhD or equivalent) in biological and/or engineering disciplines.
• At least 8 years of relevant biotech/pharma experience, ideally in a technical leadership role in a cGMP facility.
• Experience in aseptic drug product manufacturing and process development.

Responsibilities

• Provide technical input into environmental/facility/process monitoring deviations and containment actions.
• Collaborate to resolve aseptic control investigations.
• Design and implement risk-based contamination control strategies.
• Support regulatory submissions and pre-approval inspections for contamination control.
• Work with CDMOs and engineering firms on aseptic filling in GMP environments.
• Establish post-approval control strategy stewardship and monitoring.
• Coordinate with external manufacturing/testing partners for continuous improvement.
• Ensure regulatory compliance and quality culture across activities.

Skills

Aseptic processing

Sterility assurance

GMP compliance

Risk-based approach

Root cause analysis

Cross-functional collaboration

Regulatory submissions

Communication skills

Process development

Technical leadership

Education

PhD or equivalent in biological/engineering

8+ years biotech/pharma experience

Job description

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>), 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 Vertex's 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

• Advanced degree (PhD or equivalent) 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

Pay Range

$145,500 - $218,300

Benefits

• 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

• 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.

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 [e-mail].

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