Senior Specialist, Quality Assurance Operations

Landmark Bio translates groundbreaking research into life-changing medicines. We provide development, manufacturing, and regulatory capabilities to help early-stage life science innovators rapidly progress advanced therapies from bench to clinic. Launched in 2021, and based in Watertown, Mass. Landmark Bio is an unprecedented venture bringing together the best of industry, academia and research hospitals to accelerate life sciences innovation. 

We are seeking a highly motivated and team-oriented professional with entrepreneurial spirit to join our company! This is an exciting opportunity for a well-qualified candidate to join a rapidly growing company focused on turning today’s cutting-edge research into tomorrow’s breakthrough therapies.

We are seeking a Senior Specialist, Quality Assurance Operations, reporting to the Associate Director, Quality Assurance Operations. This position is responsible for reviewing and approving GMP documentation for cell therapy, vector manufacturing, fill / finish, and for providing production support.  This position is on a Tuesday through Saturday schedule, normal daytime business hours.

Responsibilities:

·       Support real-time manufacturing batch record review, CoA approval and authorization for product release for patient.

·       Review GMP documentation to support the disposition of Raw Materials, Critical Reagents, Drug Substances and Drug Products (including Lot Packets and Batch Records). 

·       Demonstrate purposeful presence on the floor, providing on the floor support during manufacturing operations. 

·       Provide QA oversight for quality records, including deviation, CAPA, change controls and investigations.

·       Develop, review and approve GMP manufacturing documentation including Standard Operating Procedures, Batch Records, Quality Events, and equipment records.

·       Support production schedules to ensure timely lot disposition.

·       Ensure compliance with cGMP regulations, guidance, and industry standards.

·       Meet performance objectives and contribute to a culture of continuous improvement. 

·       Partner closely with colleagues in Process Development, Supply Chain, Manufacturing and Quality Control to ensure effective technology transfers and right-first-time performance.  

·       Develop metrics to gauge efficiency, performance, and other relevant measurements, report to management.

·       Collaborate to close out deviations and change controls and ensure timely implementation of preventative and corrective actions.

·       Assist with documentation control tasks, such as verification, logbook and batch record management and archival.

·       Additional responsibilities as required.

Qualifications:

·       Bachelor's degree in engineering, biology, chemistry or a related field (graduate degree or certifications and continuing education a plus).

·       6-8 years of experience working in a biotechnology manufacturing environment, ideally with hands-on experience in cell and/or gene therapy. Previous experience in a GMP environment preferred.

·       Knowledge of cGMP requirements.

Landmark Bio is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.