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AR&D Data Auditor

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 is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. 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 AR&D Data Auditor supports laboratory data auditing that includes reviewing the technical documents like protocols/reports/test methods, specifications, and the SOPs etc. related to AR&D. The AR&D Data Auditor supports lab investigations, customer/agency audits and performing analytical testing as per business needs.

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

• Read and understand test methods from multiple compendia (i.e., USP/NF, EP, JP), internal Catalent methods, customer/supplier methods and other technical documents.

• Perform technical review and approval of all data including notebooks/certificate of analysis, stability summaries etc. for compliance with approved test methods, specification, and applicable internal SOPs for routine release testing of raw materials, in-process samples, finished products and stability samples for development batches, GMP/clinical batches and registration activities required for the regulatory submissions.

• Perform technical review and approval of data, protocols and reports related to method qualifications (transfers/verifications/validations) including other protocol-based studies (photostability, comparative dissolution studies, dose dump studies etc.) performed in AR&D required for regulatory submissions.

• Author / review SOP’s that fall within defined area of subject matter expertise. Review other technical documents not limited to specification, test methods, Certificate of analysis/Report of analysis, protocols/reports, and other technical documents as needed.

• Participate in customer/internal/regulatory agency audits as necessary.

• Assist in training analytical scientists.

• Perform analytical testing as per business needs and assist in laboratory investigations.

• Draft or review CAPAs and audit responses as needed.

• Other duties as assigned.

The Candidate

• Ph.D., M.S, or B.S in Chemistry, Pharmaceutical Sciences or Life Sciences (Preferred in Analytical Chemistry) Required

• Work Experience – 3+ years of pharmaceutical industry experience with a Ph.D. degree, and with at least 2 years of analytical testing/research experience using HPLC/GC/UV, etc.; OR 4+ years of pharmaceutical industry experience with a M.S degree, and with at least 3 years of analytical testing/research experience using HPLC/GC/UV, etc.; OR 5+ years of pharmaceutical industry experience with a B.S degree, and with at least 3 years of analytical testing/research experience using HPLC/GC/UV, etc.

• Understand analytical chemistry calculations such as concentrations (Area%, %w/w, ppm, µg/mL, etc.), molarity, Beer’s Law, reference standard purity on as is, anhydrous, or dry basis etc.

• Advanced knowledge and demonstrated performance in regard to all lab safety process and procedures and the ability to work safely with chemicals of varying potency.

• Previous analytical testing experience is required.

• Assisting with other personnel with lifting of liquid containers and all objects of greater than 50 lbs.

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 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 (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .