Manager QC Program Management
Manager QC Program Management
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Job Description
The Manager QC Client Services is responsible for providing support and oversight to the QC Client Services Team as they support the Quality Control and Batch Disposition departments ensuring samples are tested on time and QC deliverables as part of clients analytical implementation. Manage the OTL for analytical method implementation and support SMPs and Batch records implementation review.
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 lifecycle supply. With timetested experience in development sciences delivery technologies and multimodality 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 lifeenhancing and lifesaving treatments for patients annually.
The role:
- Be the face of Catalent Quality Control during Client onboarding
- Manage the daytoday method establishment.
- Attend client meetings to establish testing and stability protocols
- Ensure completion of project team assigned QC related activities.
- Coordinate internal testing with Quality Control group
- Coordinate product and raw material testing with external testing laboratories
- Coordinate with the stability group and clients to establish stability studies.
- Review and approve client sampling plans.
- Review and approve batch records. Ensure sample testing schedule is accurate.
- Develop and maintain QC client activities tracker.
- Communicate manufacturing and testing schedules to the Quality Control group.
- Effectively communicates with clients on QC related items/results.
The candidate:
- Masters degree in a Scientific Engineering or Biotech field with 6 8 years experience Quality Assurance/Quality Control function reviewing Analytical testing data for analytical assays such as ELISA DDPCR HPLC SDSPAGE Western blot OR as an Analytical Chemist with documentation review.
- Bachelors degree in a Scientific Engineering or Biotech field with 8 10 years experience Quality Assurance/Quality Control function reviewing Analytical testing data for analytical assays such as ELISA DDPCR HPLC SDSPAGE Western blot OR as an Analytical Chemist with documentation review.
- Proficient in Good Manufacturing Practices (GMPs) 21 CFR 210/211/600s USP and ICH Guidelines.
- At least 4 years of Progressive Leadership experience experience with Performance Management Goal Setting and Managing through Conflict.
- Demonstrable leadership experience at Catalent (including but not limited to participation in Catalentsponsored leadership programs such as NGGL GOLD GM Excellence and GROW) may be considered in place of external experience.
- Have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational as well as routine quality tasks.
- Exposure to Lean Operational Excellence highly desirable.
The anticipated salary range for this position in Maryland is $118720 $163240 plus an annual bonus. The final salary offered to a successful candidate may vary and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job type and length of experience within the industry skillset education business needs etc. Catalent is a multistate employer and this salary range may not reflect positions that work in other states.
Why you should join Catalent:
- Competitive medical benefits and 401K
- 152 hours PTO 8 Paid Holidays
- Dynamic fastpaced work environment
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7000 lifesaving and lifeenhancing 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
