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Senior Manager, Form/Fill - Bloomington Indiana
Company: Disability Solutions Location: Bloomington, Indiana
Posted On: 11/11/2024
Senior Manager, Form/FillCatalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.--Catalent's facility in Bloomington provides a fully integrated and unique model for process development, clinical and commercial mammalian cell culture manufacturing, formulation, parenteral drug manufacturing and packaging under one roof. The award-winning facility provides clinical and commercial bulk drug substance and drug product manufacturing, including liquid and lyophilized vials, and prefilled syringes, along with an array of support services.The Senior Manager, Form/Fill is responsible for increasing the ratio of value to non-value activities and eliminating waste in the overall production and supply chain from start to finish, for a defined area or operation, while being held accountable for processes, personnel, safety, compliance and meeting or exceeding the client requirements within their operational area.This is a fulltime, onsite role, Monday - Thursday; working 10 hours between the hours of 6:00PM and 6:00AMCatalent 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 - Leads a group of thirty-five or more staff, including 2 or more direct reports
- Ensures the performance and results of a Form Fill team
- Develops departmental plans and priorities to address resource and operational challenges up to 3-6 months in advance
- Ensures compliance with company SOP's, specifications, as well as cGMP, ICH, FDA, EMA regulations or guidelines
- Provides technical guidance to employees, colleagues and/or customers; Collaborates and communicates with support functions
- Schedules employees and manages workload for operational area; Supports and leads continuous improvement projects
- Reviews and approves GMP documentations while ensuring safety and GMP quality compliance; Informs personnel of communications, decisions, policies, and all matters that affect their performance, attitudes, and results.
- Hires, trains, motivates, leads, develops, and evaluates staff. Takes corrective action as necessary on a timely basis and in accordance with company policy. Ensures compliance with current federal, state, and local regulations. Consults with Human Resources Department as appropriate.
- Other duties as assignedThe Candidate
- Bachelor's degree or relevant experience required
- 4-6 years direct supervision experience required
- GMP experience required
- Ensure compliance with company SOP's, specifications, as well as cGMP, ICH, FDA, EMA regulations or guidelines
- Must be able to read and understand English written work instructionsWhy You Should Join Catalent
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