Computer System Validation Manager Jobs in Missouri

Manager, Molecular & Cellular Biology

Position Summary

• Shift: Monday - Friday 8am - 4:30pm
• 100% on-site

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 Manager in Molecular and Cellular Biology is primarily responsible for managing various sub-teams comprised of a Group leaders, Scientists and Associate Scientists. Their responsibilities will include serving as technical experts on projects, act as liaison between client and Catalent technical team, coaching and mentoring group leaders, HR activities (e.g., performance reviews, time entry approval, PTO approval, salary adjustments, etc.), supporting client audits/visits, and communicating with cross-functional teams on analytical activities for Biopharma product development under cGMP regulatory guidance for Large Molecules/Biologics product development.

The role:

• Supervise and manage various method development, method evaluation/feasibility, method transfers, method verifications, qualifications and validations, stability study and adhoc sample testing in Molecular and Cellular Biology.
• Plan, prioritize, organize, and execute the conduct of analytical work within the Molecular and Cellular Biology Laboratory in accordance with the requirements of the client contract and/or technical agreement.
• Serve as back up Project Technical Lead and could also serve as Technical Lead on projects pertaining to Molecular and Cellular Biology.
• Manage and lead computer system validation activities, as required. Ensure various instruments/Equipment in the group are in compliant status.
• Ensure cGMP practices are implemented and followed by the group and self.
• Assure the integrity and quality of analytical data produced by ensuring staff are adhering to all relevant in-house and client SOPs and methodologies and following the requirements of GMP.
• Monitor and manage projects and maintain project timelines and budget.
• Communicate effectively with clients, auditors, peers, and Directors to facilitate the smooth conduct of project activities.

The candidate:

• A minimum of a Bachelor's degree with > 5 years of relevant experience in department specific techniques with > 2 years of management experience
• Applies knowledge of the principles, theories, and concepts applicable to a wide range of work in a discipline (e.g., Biology, Chemistry, Biochemistry) and broad knowledge of principles and concepts in other disciplines.
• In-depth knowledge in instrumentation, theory, data interpretation and applications in at least one technical area. Can assess new technologies and their impact on Catalent offerings
• Experienced in most aspects of drug development and lifecycle support, and able to develop useful strategies and tactics to meet regulatory milestones
• Excellent written and verbal communications skills with internal and external customers, colleagues, and supervisor.
• Ability to communicate complex technical information to non-technical audiences
• Able to lead difficult discussions with customers and drive the to an acceptable resolution

Why you should join Catalent:

• Competitive medical benefits and 401K
• 152 hours PTO + 8 Paid Holidays
• Dynamic, fast-paced work environment
• Opportunity to work on Continuous Improvement Processes

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.