Manager, Quality Control - Clinical
Manager, Quality Control - Clinical
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Job Description
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 Catalents 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 andcompliance 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:
- Bachelors Degree in Chemistry Biology or related scientific field required. Masters 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 Emitted Dose Techniques) preferred
- Previous participation in regulatory audits preferred but ability to apply applicable regulations (FDA EU Japan USP ICH etc.) in a phase appropriate manner is required
- Thorough knowledge of chromatography (HPLC GC) FTIR and various other analytical techniques required
- Experience with statistical data analysis DOE HPLC software systems trending analysis preferred (Empower JMP etc.)
- Experience with the full life-cycle of developing and validating analytical methodologies and a strong foundation in the principles of cGMP
- Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL GOLD LEAD Now GM Excellence and GROW) may be considered in place of external experience
- Physical requirements: Individual may be required to sit stand walk regularly and occasionally lift 0-20 pounds
Why you should join Catalent:
- Defined career path and annual performance review and feedback process
- Diverse inclusive culture
- Positive working environment focusing on continually improving processes to remain innovative
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
- 152 Hours 8 paid holidays
- Several Employee Resource Groups focusing on D&I
- Dynamic fast-paced work environment
- Community engagement and green initiatives
- Generous 401K match
- Company match on donations to organizations
- Medical dental and vision benefits effective day one of employment
- Tuition Reimbursement Let us help you finish your degree or start a new degree!
- WellHub program to promote overall physical wellness
- Perkspot - offers exclusive or private discounts from approximately 900 merchants in a wide array of categories
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability you may submit your request by sending an email and confirming your request for an accommodation and include the job number title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment bank details photocopies of identification social security number or other highly sensitive personal information during the offer process and we NEVER do so via email or social media. If you receive any such request DO NOT respond it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
Required Experience:
Manager
Employment Type
Full-Time
