Aseptic Control Principal Scientist, MSAT

About the role

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.

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.
• Adhere 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.

Requirements

• 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.
• 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.

Qualifications

• Advanced degree (PhD or equivalent) in biological (microbiology preference) and/or engineering disciplines with minimally 8 years of relevant experience in biotech or pharmaceutical industries, ideally in a technical leadership role in a cGMP facility.

Skills

• Knowledge of cGMP requirements.
• 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.

Benefits

Some roles may also be eligible for overtime pay, in accordance with federal and state requirements.

Pay

Pay Range $145,500 - $218,300

Schedule

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. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.