Associate Lead I - Biomanufacturing, Compliance

Associate Lead I - Biomanufacturing, Compliance

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 Manufacturing Process Compliance team provides support for cGMP Manufacturing operations, ensuring compliance with all applicable internal SOPs as well as regulatory and client requirements.

This is a full-time on-site hourly position, Sunday - Wednesday 6:00am to 4:00pm

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. 

The Role:  

• Facilitate Rapid Response Team as deviations occur, documenting critical information to determine true root cause
• Provide timely review of logbooks as needed to ensure data complies with cGMP expectations
• Participate in initiatives to improve process compliance culture, including on-going cGMP understanding and application, including self-audit and CAPA programs
• Participate in internal audits and assist in closure of applicable findings
• Actively engage in Inspection Readiness activities and teams
• Informs personnel of communications, decisions, policies, and all matters that affect their performance, attitudes, and results as it relates to GMP compliance
• Assist to write and revise SOPs (Standard Operating Procedures) when gaps are identified
• Assists in identifying improvements for safety and provides on the floor manufacturing support
• Other duties as assigned

The Candidate:  

• Requires Bachelor's Degree in technical discipline (e.g., biology, biotechnology, engineering) or related life science field with no experience required OR
• Associates Degree in technical discipline (e.g., biology, biotechnology, engineering) or related life science field with minimum of 1 years’ related experience OR
• High School Diploma with minimum of 4 years’ related experience
• Frequent sitting, standing, walking, reading of written documents and use of computer monitor
  screen, reaching with hands and arms, talking, writing, listening is required
• Occasional stooping, kneeling, crouching, bending, carrying, grasping is required
• Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds is required

Why you should join Catalent:

• Defined career path and annual performance review and feedback process 
• Diverse, inclusive culture 
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 
• 152 hours of paid time off annually + 8 paid holidays 
• Competitive salary with yearly bonus potential 
• Community engagement and green initiatives 
• Generous 401K match and Paid Time Off accrual 
• Medical, dental and vision benefits effective day one of employment 
• Tuition Reimbursement

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.