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Product Manager - Annual Product Reviews

Position Summary

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. Catalent’s Winchester location is the flagship US manufacturing location for large scale oral dose forms, with integrated analytical and development services. With 28 years of expertise in product development, technology transfers and commercial manufacturing, and roots in industry-leading Glatt technology.

The Product Manager (APRs) is responsible for managing the Annual Product Review (APRs) program at Catalent-Winchester. The Product Manager (APRs) develops and supports departmental strategic goals for Catalent to assure the highest quality standards and regulatory compliance.

Monday-Friday 8 AM-5 PM

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

+ Authors Annual Product Reviews to verify the consistency of the process, to assess trends, to determine the need for changes in specifications, production, manufacturing, and/or control procedures and to evaluate the need for revalidation.

+ Primary SME for APRs for clients and internal customers; collecting processing data from Executed Batch Records and/or COAs.

+ Responsible for supporting internal, client, and regulatory audits; maintaining systems and procedures to monitor the health of the quality system, and audit readiness.

+ Responsible for performing statistical analyses and inferring process performance for each of APR as scheduled.

+ Responsible for the maintenance, development and nurturing of the client partnership in regard to APRs to ensure alignment and consensus; Effectively maintains client data sets.

+ Effectively coordinates functions of internal QA organization with customers and necessary Catalent departments.Specifically: Authoring the Annual Product Review/Annual Quality Review.

+ Interfaces with the Catalent internal teams (Validation, Technical Writers, QA, QC, Product Development and Customer Service departments as needed to communicate and maintain a partnership necessary for APRs management to ensure highest quality standards and regulatory compliance.

+ Coordinates key systems including Customer Complaints and functions impacting the Quality area related to assigned products and clients.

+ Other duties as assigned.

The Candidate

+ Bachelor of Science in a pharmaceutical applicable field (e.g., Science, Biology, Chemistry, or Engineering) or Five (5) years of experience in quality and/or regulatory in the pharmaceutical industry.

+ Must be able to demonstrate successful communication skills at all levels of internal and client organizations and regulatory agencies.Effectively maintaining these partnerships to alignment and action.

+ Must be knowledgeable in auditing principles and be able to audit/evaluate manufacturing and support functions at the site for customer and regulatory audit preparedness; Knowledge of quality, regulatory and legal standards including USP, EP, JP, GMP, ICH, DEA and FDA.

+ Fully functional computer skills in Microsoft Word, Excel, and Power Point. Preferred experience in Minitab, TrackWise and JDE.

+ Demonstrated ability to read, write, and speak clear English.

+ Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional bending, grasping, carrying, stooping, kneeling, crouching. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 35 pounds. Individual may be required to sit for extended periods. Specific vision requirements include reading of written documents and use of computer monitor screen frequently.

Why You Should Join Catalent

+ Several Employee Resource Groups focusing on D&I

+ Tuition Reimbursement – Let us help you finish your degree or earn a new one!

+ Generous 401K match

+ 152 hours accrued PTO + 8 paid holidays

**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 (https://careers.catalent.com/us/en) 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 [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.

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 [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .