Manufacturing Science and Technology Principal Scientist

Vertex Inc.•Boston, MA

2d•Hybrid

About The Position

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.

Requirements

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.
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.

Nice To Haves

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.

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.