Senior Manager, Form/Fill

Posted 9 Days Ago
Be an Early Applicant
Bloomington, MN
Mid level
Biotech • Pharmaceutical
The Role
The Senior Manager, Form/Fill leads a team ensuring compliance with regulations and operational efficiency in the production process. They develop departmental plans, manage staff, and support continuous improvement projects while maintaining safety and quality standards.
Summary Generated by Built In

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
  • 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 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 [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.

The Company
HQ: Somerset, NJ
13,715 Employees
On-site Workplace
Year Founded: 2007

What We Do

Catalent Inc. (NYSE: CTLT), an S&P 500® company, is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs.

Catalent supports our partners in introducing 200 new products and manufacturing over 70 billion doses each year. Since becoming a publicly traded company in 2014, we have grown to become a community of approximately 19,000+ workers who support over 7,000 products for over 1,000 customers around the world. We share a common goal: to put patients first and help people around the world live better and healthier lives.

Catalyst + Talent. Our name combines these ideas. From drug and biologic development services to delivery technologies to supply solutions, we are the catalyst for your success. We have the deepest expertise, the broadest offerings, and the most innovative technologies to help you get more molecules to market faster, enhance product performance, and provide superior, reliable manufacturing and packaging results.

more products. better treatments. reliably supplied.™

Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!

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 life.

Grow with us. Be challenged. Make a personal impact.

Visit https://careers.catalent.com/us/en to explore career opportunities

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