Job Description

ASSOCIATE DIRECTOR, MSAT - TECHNICAL STANDARDS LEAD

DESCRIPTION

Join a global biopharmaceutical leader at the forefront of innovation and expansion. This company is investing heavily in its Rockville, Maryland site-an advanced hub for biologics and cell therapy manufacturing. With a growing portfolio of legacy and next-generation commercial products, the site is undergoing a major transformation to support cutting-edge therapies and global supply. As part of this exciting growth, we are seeking a Technical Standards Lead to play a pivotal role in shaping the future of manufacturing science and technology at this flagship location.

The Technical Standards Lead will be responsible for developing and implementing site-wide strategies in lifecycle management, cleaning validation, contamination control, and single-use technologies. This role will lead a specialized team and collaborate closely with global MSAT functions to ensure alignment with industry best practices and regulatory expectations. This is a high-impact leadership opportunity for someone passionate about technical excellence, innovation, and cross-functional collaboration.

RESPONSIBILITIES

• Provide leadership and guidance to a team of 2-3 specialists focused on lifecycle strategy, cleaning validation, and single-use systems.
• Establish and maintain site-level technical standards and procedures that align with global MSAT frameworks.
• Act as the primary subject matter expert during audits and inspections concerning contamination control and cleaning validation practices.
• Design and implement long-term strategic plans for technical standards, integrating evolving regulatory requirements, GMP expectations, and industry innovations.
• Lead initiatives to enhance commercial manufacturing processes, supporting both existing and newly launched products.
• Partner with cross-functional teams-including Quality, Engineering, Supply Chain, Procurement, and Regulatory Affairs-to ensure seamless and compliant operations.
• Conduct risk assessments for new materials and technologies, ensuring they align with validation and lifecycle management principles.
• Drive the implementation and continuous improvement of single-use technologies and extractables & leachables (E&L) programs.
• Represent the site in global forums and working groups to contribute to and adopt best practices across the organization.
• Ensure robust execution and compliance of process validation activities, including PPQ and CPV, throughout the product lifecycle.

Knowledge, Skills, and Abilities:

• A bachelor's degree in a scientific or engineering field is required; an advanced degree is a plus.
• 10+ years of hands-on experience in biopharmaceutical process development, MSAT, or CMC roles, with a strong emphasis on lifecycle management strategies.
• Comprehensive knowledge of ICH regulations, GMP standards, and global regulatory expectations for commercial-scale operations.
• Demonstrated proficiency in process validation methodologies, including PPQ execution, CPV implementation, and cleaning validation protocols.
• In-depth experience with single-use systems and extractables and leachables (E&L) assessments is essential.
• Proven leadership capabilities with the ability to guide teams and influence stakeholders across departments and global functions.
• Strong communication skills, both written and verbal, with the ability to clearly convey complex technical concepts to diverse audiences.
• Strategic mindset with excellent prioritization skills and a proactive approach to resolving technical and operational challenges in a dynamic environment.

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