Operations Project Lead

Operations Project Lead I Position Summary

• Work Schedule:
  
  Monday-Friday, core hours 8am-4:30pm
• 100% on-site (San Diego)

Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and Catalent’s San Diego facility focuses on early-stage development of small molecule and peptide drug candidates from the bench to the clinic. This facility offers an array of services that support oral and injectable dosage forms that include preformulation testing, formulation and analytical development, cGMP manufacturing and clinical packaging, labeling, and worldwide distribution.

Our San Diego location is the home of our Catalent Spray Drying technologies with downstream roller compaction capabilities to support the needs of our client’s most challenging compounds.

An Operations Project Lead (OPL) is responsible for leading Good Manufacturing Practice (GMP) manufacturing productions for Phase I and Phase II clinical trial productions and has a focus on understanding the processes used at Catalent San Diego for manufacturing, the quality systems and requirements for early phase manufacturing. You will be a key member of a multi-site mission to deliver unparalleled service to our clients and quality drug products to the patients.

• Co-manage cGMP runs with Development personnel, project manager and client. Serve as the first line of contact for internal team and client during manufacturing preparation, production and post-production stages. Host client on-site meetings and teleconferences independently.
• Provide troubleshooting support in MFG suites and propose solutions to supervisor or other coordinators for most production problems. Draft production deviations, corrective action/preventative action plans, and product-related complaints independently.
• Work with a cross-functional team to ensure successful process transfer from development into cGMP manufacturing.
• Draft and review Master Batch Records for resupplies or simple processes independently, including but not limited to weighing, blending, milling, sieving, profiling, Xcelodose encapsulation.
• Draft and review Master Batch Records for complex productions with minimal supervision, including but not limited to the following types of cGMP productions: automated encapsulation, tableting, coating, fluid bed granulation, roller compaction, liquid fill/banding and spray drying.
• Coordinate manufacturing preparation activities. Provide batch record training to production technicians on complex processes.
• Prepare clinical product label documentation and generate clinical product labels for productions. Review executed batch record and address client comments. Revise SOPs and streamline production batch records.
• Other duties as assigned.

• Bachelor’s degree in science, industrial engineering or logistics is highly desirable. High School Diploma is accepted as a minimum.
• No GMP industry experience required. Highly prefer candidates with two (2) years of GMP experience.
• Advanced skills with Microsoft Products preferred (Word, Excel, PowerPoint, etc.).
• Physical requirements: Individual may be required to sit, stand, walk regularly and occasionally lift up to 35 pounds; ability to communicate orally with customers, vendors, and co-workers. Regular use of telephone and email. Hearing, vision, and speaking within normal ranges is essential for normal conversations, to receive ordinary information and to prepare or inspect documents. Good manual dexterity for the use of common office equipment such as computer terminals, calculator, copiers, and fax machines.
  
  Good reasoning ability is important. Able to understand and utilize management reports, memos, and other documents to conduct business.

• The anticipated salary range for this role in San Diego, CA is $52,000 to $65,000 (hourly) annually. 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…