Job DescriptionPosition Overview:Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start hereThis role reports directly to the Director, Operations and Supply Chain.The Pre-Production Manager leads the activities of the Pre-Production group. The Pre-Production group's function is to prepare batch records for the Production operation and to provide label design support for clients. The Clinicopia group's function is to facilitate the design of outsourced labels and to design in-house labels for use in Packaging and Distribution of commercial and clinical products. The Manager utilizes knowledge of the packaging industry and clinical experience to provide processes and systems that operate in an effective manner to positively impact the SQDC of the business. As the first line interface with Project Management and Catalent's customers, these groups provide the technical expertise required to efficiently design, onboard, and execute Packaging and Distribution programs that affect the health and well-being of patients involved in clinical trials or receiving commercially available medication. The Manager is also closely tied in with the Business Development and Client Services teams, working closely to define proposals that highlight the strengths of the Clinical Supply Services site.The RoleLeadership:* Oversee the daily activities of the Pre-Production group* Sets priorities for the group to ensure task completion and coordinates activities with other departments to ensure provision of package designs, batch records, components, and label design* Have an exceptional understanding of regulations in respect to cGMPs within Clinical and Commercial Operations* Adapts departmental plans and priorities to address resource or operational challenges* Provides insight and guidance into event Root Cause Analysis (including Safety, Quality and Delivery events) and reviews/approves reports (i.e. discrepancies, deviations, and complaints)* Perform formal 1-on-1s with all direct reports on a periodic basis and provide constructive feedback and development activitiesSafety:* Responsible for the identification, investigation, and improvement of Safety Concerns (as assigned) for the Pre-Production group* Responsible for the identification, investigation, and improvement of Safety Events (as assigned) for the Pre-Production groupQuality:* Accountable for the overall training compliance of the Pre-Production group, including GMP, HR, and Safety Training (ComplianceWire)* Accountable for the overall quality of output produced by the Pre-Production group, including batch records, specifications, package designs and label design* Provides oversight and assistance with investigations related to Pre-Production (discrepancies, deviations, and complaints) as well as CAPA identification and closure (as assigned)Delivery:* Understands the daily, weekly, and monthly schedule for the Pre-Production group and services daily activities to meet on time delivery* Responsible for communication between the group and other departmentsCost:* Responsible for ensuring resources are available for participation in Continuous Improvement activities (e.g. Process Improvement Group projects and Kaizen events)* Participates in the outline and review of proposals and agreements for clinical and commercial projects for the full CSS business lineAdditional Responsibilities:* Maintain a safe working environment and proactively identify safety concerns that may affect individual or other colleagues* Proactively investigate, evaluate, and implement the latest industry trends* Ensure team members are up-to-date with the latest innovative solutions* Participate in GEMBA activities to identify Organization and Discipline opportunities* Maintain a current training record* Prior experience with batch records and packaging operations required* Trained and able to make decisions and perform tasks to support other operational groupsCommunication Responsibilities:* Coordinate information and communication for designated projects* Provide weekly, monthly, and quarterly performance updates related to the SQDC of the groupThe Candidate* Bachelor's degree in Business or Science or equivalent knowledge and/or experience required* Five years of people management is required* Five years of relevant industry experience is required* Possess strong computer skills and be proficient in both Microsoft Word and Excel* Possess the ability to work under tight and emergent deadlinesPosition Benefits* Medical, Dental, Vision and 401K are all offered from day one of employment* 19 days of paid time off annually* Potential for career growth within an expanding team* Defined career path and annual performance review and feedback processCatalent's Standard Leadership Competencies* Leads with Integrity and Respect* Delivers Results* Demonstrates Business Acumen* Fosters Collaboration and Teamwork* Champions Change* Engages and Inspires* Coaches and DevelopsCatalent 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 www.catalent.com/careers to explore career opportunities.Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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.