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Investigation Manager, Technical Services

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.

St. Petersburg is our primary softgel development and manufacturing facility in North America with a capacity of 18 billion capsules per year. The featured RP Scherer softgel technology is a proven oral drug delivery solution to enhance bioavailability of poorly soluble Rx and OTC drug candidates. Non-gelatin based OptiShell® and Vegicaps® capsules expand the range of molecules into softgel, ideal for challenging fill formulation. Within the Catalent network, we offer a broad range of integrated formulation.

Technical Services is responsible for providing technical commercial support over the lifecycle of all products, driving continuous improvement throughout the manufacturing environment, facilitating commercial technology transfers and ensuring Launch Excellence during the new product introduction process. The **Investigation Manager, Technical Services** primary tasks performed will include leading a team of investigators working on proper investigation and documentation of the deviations, root cause analysis, impact, and corrective actions for the deviation management process for the site. The **Investigation Manager, Technical Services** will collaborate with members of multiple departments and QA to ensure all deviations are investigated and documented properly in a timely manner. Ensure that effective corrective and preventive actions are instituted in a timely manner. Coach investigators and other department investigation authors on best practices and technical writing skills to maintain a site deviation mentorship program. Success of the **Investigation Manager, Technical Services** is measured by improvement in site deviation metrics, such as reduction in number of overdue deviations, increase in number of deviations written “right first-time,” and decrease in the average cycle time for record closure. Provide effective tracking and trending of site deviations and CAPA through various metrics including issue types, root cause, and product types. Support deviation and CAPA related metrics and present site leadership at weekly DRB and CRB meetings.

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. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

The Role

+ Manage complex and high-level deviations, support OOS investigations, and collaborate with internal Catalent stakeholders to support the effective execution of the investigation and CAPA systems.

+ Provide and maintain lead investigator, reviewer/approver, mentorship/coaching, rapid response, root cause analysis, technical writing, CAPA, and/or TrackWise® training at the site to support consistent and effective execution of the deviation management system. Recommend process changes as a result of trends from CAPA/Complaints/Investigations.

+ Provide oversight to ensure the site deviation training program is maintained in compliance with regulatory and customer requirements. May author other types of quality system documents as directed or assigned by QA management.

+ Ensures the adherence by team members to the standards of quality ruled by the current Good Manufacturing Practices and the Company’s Quality Policies. Effectively manages and schedules investigation assignments and ensures compliant documentation by team members. May include directly completing complex / critical deviation investigations at a high-level of expertise with technical writing and GMP understanding.

+ Effectively compile and interpret data and advanced level ability with identifying the impact of deviations to product quality in collaboration with subject matter experts. This includes clearly defining problems, collecting, and organizing existing data, comparing potential causes with relevant data and processing standards, identifying probable root causes, conducting interviews and SME discussions, and determining the best solutions for improvement of manufacturing processes, standard operations procedures (SOPs) and supply chain business practices.

+ Strong reasoning skills to complete thorough review of supporting documentation including batch documentation, ancillary documentation, test results /CoAs, Product specifications, training records, SOPs, calibration records, packaging and validation protocols, and other technical documents in support of the investigation process and root cause determination.

+ Participate and propose additional quality initiatives as required. Facilitate completion of site metric reporting related to deviations (daily, weekly, monthly, and quarterly).

+ Evaluate data and identify potential trends. As trends are identified, work with functional areas to develop remediation plans. Assist with Management Review meetings. Effective communication with management regarding status of deviations.

+ Other duties as assigned.

The Candidate

+ Requires a Bachelor’s degree in a technical/ scientific field (Chemistry, Microbiology or Engineering) relevant to pharmaceutical manufacturing.

+ Requires a minimum of 5 years’ experience in a pharmaceutical manufacturing environment.

+ Requires a minimum of 3 – 5 years’ experience with investigation systems or deviation management. Solid understanding of cGMPs as they apply to documentation and deviation systems. Pathwise or other training / certifications related to root cause investigation practices.

+ Direct, hands-on experience with deviation management and deviation management systems; knowledge of TrackWise system is preferred.

+ Individual may be required to sit, stand, walk regularly and occasionally lift to 15 lbs; no lifting greater than 44.09 pounds without assistance. Specific vision requirements include reading of written documents and use of computer monitor screen frequently. Ability to work extended hours or off-hours as required.

Why you should join Catalent:

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

+ WellHub program to promote overall physical wellness.

+ 152 hours of PTO + 8 paid holidays.

+ Medical, dental and vision benefits effective day one of employment.

+ Defined career path and annual performance review and feedback process.

+ Diverse, inclusive culture. Several Employee Resource Groups focusing on D&I. Community engagement and green initiatives.

+ Dynamic, fast-paced work environment.

+ Positive working environment focusing on continually improving processes to remain innovative.

+ Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.

+ Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.

**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) .