Job Description

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 incumbent will work cross-functionally with colleagues in the BSMO/CMSC, Regulatory, Quality and R&D of Vertex on the design of processes and technologies required to produce aseptic and/or low bioburden drug products to successfully commercialize an exciting and diverse portfolio of innovative pipeline programs. In addition, the successful candidate will support the implementation of risk-based design and controls for low bioburden process operations for production of drug substance/intermediates for manufacturing. 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.

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.

Key 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.

Required Qualifications:

• 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, and 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 proven ability to work seamlessly across teams and develop excellent relationship and partnerships with peers is critical to success in this role.
• Demonstrated understanding of the principles and applications associated with commercial manufacturing operations.
• Strong understanding of the technical aspects of manufacturing, testing, and controls and regulations governing pharmaceutical operations
• Strong knowledge of cGMP requirements
• 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
• Excellent team player and be able to build and sustain organization respect and trust at all levels
• Problem solver with a hands-on approach and ability to anticipate adverse scenarios and provide contingency plans to address them
• Resilient and able to work well in a demanding, fast paced entrepreneurial environment
• Sound judgment and business acumen with personal versatility and flexibility as business and team evolve 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.

Company Information