Manager, Quality Control - Clinical

Manager, Quality Control (Clinical and Tech Transfer Team)

Position Summary:

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

The Boston-area facility is Catalent’s global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging. On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America.

Catalent Pharma Solutions is hiring a Manager, Quality Control (QC) who is a key analytical leader in the Clinical and Tech Transfer group in our Good Manufacturing Practices (cGMP) facility. The Manager, QC – Clinical is an essential member of site management who oversees the activities and associates of the department in efforts that relate to analytical services for clinical and development purposes. This individual provides strategic and operational direction ensuring that GMP testing is conducted in line with the appropriate expectations, guidelines and/or regulatory test standards.

This is a full-time on-site salaried position: Monday – Friday on day shift.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. 

The Role:

• Manages the analytical services for technology transfer and onboarding of new business. Manages the analytical services for development and clinical projects. Represents the QC lab in new client meetings, including laboratory tours and presentations
• Ensures effective and efficient operations of the laboratory in terms of workflows, personnel flows, laboratory equipment, and staff training
• Responsible for GMP compliance as related to the laboratories, equipment, and staff. Supports compliance inspections conducted by external and internal sources (i.e. health authorities, clients, self-inspections)
• Understands regulatory requirements and their application as suitably scoped to support process feasibility activities, technical transfers, clinical development, and clinical/commercial product and device release and stability efforts
• Has oversight of investigations relating to the QC laboratory as well as the applications of any corrective and preventative actions 
• Manages personnel who maintain equipment related data for trending, continuous improvement, and application of effective preventative maintenance procedures. Manages personnel maintaining laboratory supplies and inventory and who serve as the point of contact for instrument acquisitions/repairs/qualifications
• Ensures effective performance management process is in place and specific development plans implemented for each team member and provides real time feedback and coaching in addition to scheduled performance reviews. Assists with talent recruitment and leads a highly motivated, efficient, and effective team
• Inputs laboratory/analytical budget and manages spend activities to approved budget. Collaborates with other senior level personnel to ensure consistent application of company policies and practices as well as promoting new policies and programs tactfully and authentically
• All other duties as assigned

The Candidate:

• Bachelor’s Degree in Chemistry, Biology or related scientific field required. Master’s Degree in Chemistry, Biology or related scientific field preferred
• Minimum of eight (8) years of experience working in a cGMP regulated environment executing or overseeing Analytical testing and related activities required
• Prior supervisory and/or managerial experience required
• Experience in Metered-Dose Inhaler (MDI) or Dry Powder Inhaler (DPI) (analytical test methods preferred (i.e. Andersen Cascade Impactor and Emitt