Position Overview:
Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents , ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here
Position Summary
Catalent is looking to recruit a Production Manager to join our growing team in San Diego, CA.
This position requires a working knowledge of clinical applications regarding study phases I through IV, randomization schedules, open label, blind labelling, dose titration, double blind, double dummy, study collation and treatment groups. Department assignments cover multiple look-alike blister card packaging, over-encapsulation, bottle filling, pouching operations, clinical labelling, kit assembly, collating and distribution.
The Production Manager role is critical to our patients. This is a key role to ensure that quality drug products reach patients safely and efficiently. Quality, safety and on-time delivery is a must to be successful in this role!
The Role
- Direct and supervise the work activities of the Production Supervisors
- Monitor, organize and perform all functions associated with packaging of clinical trial supplies and assure compliance to GMPs, SOPs, FDA, DEA and OSHA rules and regulations
- Work closely with Clinical Coordinators to establish production needs and requirements for ongoing and future studies; Implement procedures to increase productivity and decrease downtime
- Oversee both primary and secondary areas equipped with various pharmaceutical packaging equipment including automated bottle line, form, fill and seal, card sealing, labeling and patient kit assembly; Responsible for maintaining and ordering personnel, safety, disposable and support packaging supplies
- Responsible for completing batch records in a timely manner; Investigate and prepare out of specification reports related to production
- Security, accountability, and reconciliation of controlled substance in clinical production
- Develop, review and edit related production SOP’s (operational, maintenance, cleaning)
- Stage, reconcile and perform inventory label generation in JD Edwards
The Candidate
- Bachelor of Science in Health/Chemistry/Pharmacy or related field and 10+ years Clinical, Contract or Production experience
- Detailed knowledge of the Clinical Supply Process, Pharmaceutical Packaging, and Manufacturing
- Demonstrated ability to supervise professional, technical and union staff
- Demonstrated ability to mentor, train, motivate, direct, and empower direct reports
- Excellent interpersonal and communication skills; Computer literate (Microsoft Word) and on-the-job experience with JD Edwards or similar ERP systems
- In-depth knowledge of cGMPs, DEA, OSHA rules and regulations ; Knowledge of packaging equipment in a Just-in-Time environment; Proven ability to develop Standard Operating Procedures
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
Position Benefits
- Potential for career growth within an expanding team
- Defined career path and annual performance review and feedback process
- Cross functional exposure to other areas of Catalent
- Medical, Dental, Vision and 401K are all offered from day one of employment
- 19 days of paid time off and generous paid holidays annually
About Catalent San Diego
Catalent San Diego, 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, pre-formulation 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.
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.
Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
personal initiative. dynamic pace. meaningful work.
Visit www.catalent.com/careers to explore career opportunities.
C atalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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 [email protected] . 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.
Source: Indeed.com
Click Here To Apply
