Catalent
Senior Manager, Form/Fill
Catalent, Bloomington, Indiana, United States, 47401
Senior Manager, Form/Fill
Catalent 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 6:00AM
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
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 assigned
The Candidate
Bachelor’s degree or relevant experience required
4-6 years direct supervision experience required
GMP experience required
Must be able to read and understand English written work instructions
Why You Should Join Catalent
Competitive medical benefits and 401K
152 hours of PTO + 8 Paid Holidays
Dynamic, fast-paced work environment
Opportunity to work on Continuous Improvement Processes
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 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.
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Catalent 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 6:00AM
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
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 assigned
The Candidate
Bachelor’s degree or relevant experience required
4-6 years direct supervision experience required
GMP experience required
Must be able to read and understand English written work instructions
Why You Should Join Catalent
Competitive medical benefits and 401K
152 hours of PTO + 8 Paid Holidays
Dynamic, fast-paced work environment
Opportunity to work on Continuous Improvement Processes
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 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.
#J-18808-Ljbffr