 |
Manager, QC Program Management - Severn Maryland
Company: Disability Solutions
Location: Severn, Maryland
Posted On: 02/07/2025
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 client's 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 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 role: - Be the face of Catalent Quality Control during Client onboarding
- Manage the day-to-day 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, SDS-PAGE, Western blot OR as an Analytical Chemist with documentation review.----
- Bachelor's 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, SDS-PAGE, 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 Catalent-sponsored 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 $118,720 $163,240 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 multi-state employer, and this salary range may not reflect positions that work in other states.Why you should join Catalent:
|
 |
RSS Job Feeds