Operations Project Lead I

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.

The Role:

• 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

The Candidate:

• 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.

Pay:

• 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 may not reflect positions that work in other states.

Why you should join Catalent:

• Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment.
• Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement.
• Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.  
• Several Employee Resource Groups focusing on Diversity and Inclusion.
• Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment. 
• 152 hours of PTO + 10 paid holidays.
• Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic.
• Tuition Reimbursement – Let us help you finish your degree or earn a new one!
• 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 7,000 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 DisabilityAccommodations@catalent.com. 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 spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.