- Bachelor's Degree
- Master's Degree
- Health Insurance
- Vision Insurance
- Dental Insurance
- Paid Time Off
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 here
The Director of Manufacturing (Upstream) is responsible for leading multiple upstream suite teams while overseeing the GMP manufacturing process for viral vector-based gene therapy through a broad knowledge of theories and principles utilized to solve operational as well as routine tasks in the production of bulk biologics. This is an opportunity to grow and develop new teams for a state-of-the-art gene therapy manufacturing facility in Harman’s, MD near Baltimore-Washington International (BWI) airport. Experiences will include not only the leadership and development of high performing teams but the opportunity to take part in capital expansions.
The Director of Manufacturing (Upstream) is critical to our patients because they have direct responsibility for manufacturing life altering products to ensure that meets our quality and safety standards. Keeping patient safety at the forefront and executing with efficiency always. Quality, safety and on-time delivery is a must to be successful in this role!
Responsible for managing multiple teams of leaders and associates across multiple campaigns and shifts from suite start up to routine operations.
Oversight of upstream production operations of cell culture processes including cell banking, cell expansion, bioreactor set up & operation, harvest, clarification and bulk fills.
Ensures the successful technical transfer of projects in partnership with the Tech transfer group
Works closely with the production staff to troubleshoot process and equipment problems while ensuring appropriate and proactive client and internal stakeholder communication
Will oversee and ensure compliance when creating, revising, and editing procedures and specs as needed
Leads by example, keeping in mind organizational values, policies and goals.
Proactively partners with Human Resources to attract and retain top talent and takes an active role in ensuring new employee onboarding and OJT is a positive experience.
Ensures the proper processes are in place for GMP and Safety training of staff, with a focus on cross-training and continuously improves production records
Works closely with senior management to initiate new production projects and assists in developing processes/techniques to meet contract objectives
Effectively communicates results of departmental work through team discussions and documentation
Interacts with clients on presentations and project results; will also work closely with clients during initial and subsequent manufacturing campaigns
technical aspects of PM related software used by site.
B.S. in Engineering or Science discipline and 12+ years of GMP biologic manufacturing experience OR M.S. in Engineering in a Science discipline plus 10+ years of GMP biologic manufacturing experience. Some or all this experience should be in upstream processing.
Upstream experience includes cell culture techniques and processes, disposable single-use bioreactors (WAVES, Xcellerex, iCellis), aseptic technique, harvest, clarification (e.g. depth filtration, centrifugation), TFF filtration, etc.
Downstream or previous viral vector manufacturing experience is a plus. Scope of role can expand to include downstream operations depending on candidate’s experience and capability.
Must have experience in a CDMO or CMO environment.
Join a high growth and fast paced organization with a people focused culture
Global exposure, defined career path and annual performance review and feedback process
Competitive Medical, Dental, Vision and 401K
Paid time off annually +7 paid holidays
Employee Stock Purchse Plan
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 www.catalent.com/careers to explore career opportunities.
C atalent 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.