Catalent is a leading provider of advanced technologies and outsourced services for the pharmaceutical, biotechnology and consumer health industry. Catalent develops, manufactures, packages and distributes pharmaceutical and other products for customers in nearly 100 countries.
Catalent Pharma Solutions is looking to hire an experienced
Quality Control Manager
for our San Diego, CA team. The QC Manager will report to the Director of Analytical Development & Quality Control and will be responsible for management of a technical sub-function (laboratory operations), as well as provide support to the Quality Control group. They will be responsible for creating a culture of learning, continuous improvement, and laboratory excellence through training, improvement initiatives, and collaboration. The QC Manager must demonstrate flexibility and adaptability to the ever-changing demands of the department and maintain excellent communication with the department head as well as the heads of other departments (Quality Assurance, Analytical Development, Pharmaceutics, Manufacturing, etc.).
The Role (daily responsibilities)
- Continuous evaluation of laboratory and QC department operations to provide options for improvement of efficiency, reduction of deviations, cost-saving initiatives, and lean operations
- Trend deviations to assist with determining department training needs, and work with the Training Coordinator to optimize training program
- Update the department head on the progress of all activities, and providing applicable metrics on capacity, productivity, process improvements, and deviations. Participate in group meetings, inter- and intra-department meetings, and conference calls with minimal assistance from the department head.
- Lead Continuous Improvement initiatives across Catalent to promote collaborative usage of the laboratories across cGMP/R&D
- Direct supervision of QC personnel (6-8 avg), including managerial responsibilities such as the allocation of resources, organization of projects and performance reviews
- Overseeing client contact (written and oral) for all applicable projects (maintained by direct reports or as part of functional role), including the handling of issues or sensitive subjects that arise
- Reviewing and interpreting data for all activities (maintained by direct reports or as part of functional role) and reporting any issues to the department head and other senior leadership in a timely manner
- Expertise in the use of analytical instrumentation and application of technical guidance to junior analysts on method and instrument trouble shooting and communicating issues to department head
- Responsible for understanding, maintaining, and optimizing expenses for the department. Approval of POs, work orders, and PTO for direct reports
The Candidate (requirements)
- Bachelor's degree, in a scientific discipline from an accredited university, with 8+ years of applicable laboratory experience. OR a Master's degree, in a scientific discipline from an accredited university, with 5+ years of relevant laboratory experience.
- Requires 3+ years of proven people management experience as this role will supervise ideally 6-8 direct reports (laboratory and metrology operations)
- Prior cGMP experience is required to be considered. Ability to understand and apply ICH and FDA guidance.
- Strong communication skills (written and oral/presentation) as this role collaborates with Analytical Development, Quality Assurance, Manufacturing, Engineering, Continuous Improvement, and Pharmaceutics departments as well as external clients
- Demonstrated hands on proficiency with many common standard lab practices and expertise in a variety of analytical techniques (U/HPLC required. Dissolution, GC, FTIR, XRD, TGA, DSC, compendial techniques preferred)
- Proficient experience with Microsoft Word, Excel, PowerPoint required. Experience with Visio, SharePoint, and OneNote preferred
- Relocation Assistance is NOT available for this position.
Catalent’s standard leadership competencies that are used to interview and for Performance & Development
- Leads with Integrity and Respect
- Delivers Results
- Demonstrates Business Acumen
- Fosters Collaboration and Teamwork
- Champions Change
- Engages and Inspires
- Coaches and Develops
- Potential for career growth within an expanding team
- Defined career path and annual performance review and feedback process
- Medical, Dental, Vision insurance and 401k are all offered from Day One of employment
- 19 days of paid time off (PTO) and generous paid holidays annually
About Catalent San Diego
Catalent San Diego, Inc. (Formerly Pharmatek Laboratories, Inc.) is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. Catalent San Diego focuses on bringing client drug compounds from discovery to the clinic with services that include analytical development, preformulation testing, formulation development, GMP manufacturing and stability storage and testing. At Catalent San Diego, we recruit and develop exceptional individuals with a passion for science and determination to excel. We offer a technically challenging and stimulating environment and the opportunity to learn from the best. We provide a generous benefits package, on-site gym and fitness programs, team sports, activities and competitive compensation.