Manager, Manufacturing
Summary:
Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC's I-270 Technology Corridor, top universities, and government agencies.
The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse.
The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing.
Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.
The Manager, Manufacturing is accountable for leading teams to execute procedures for upstream, downstream, and solution preparation manufacturing using SOP's and batch records. Operating production equipment in support of all drug substance manufacturing. The Manager, Manufacturing is accountable for ensuring overall compliance and operational execution meets the standards required, and that expectations established by leadership are being met at all times.
This is a full-time on-site position, M-F 8am-5pm
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:
- Assure shift supervisors are leading their teams as expected.
- Act as the single point of accountability during off-shift operations.
- Triage issues occurring on the floor and work with Quality and SMEs to determine if deviations are required.
- Provide guidance for all shift supervisors with respect to compliance, operational issues, personnel management challenges, and logistics.
- Draft and revise official manufacturing documents, SOPs, Batch Records, Validation Protocols.
- Lead initiation and closure of deviations; may serve as the lead in the departmental investigation and be responsible for closing out deviations and CAPAs.
- Coordinate with other production supervisors, managers, and project managers to execute production campaigns on-time.
- Ensure batches adhere to established Quality standards.
- GMP batch review and close-out with Quality Assurance group.
- Collaborate with MST and development groups to assist with tech-transfer, scale-up, and translation activities.
- Provide input for hiring new manufacturing associates and conduct interviews.
- Provide daily production updates to production managers, client representatives, and project managers.
- Provide guidance for continuous improvement initiatives with Upstream team.
- Represent the department to clients and on cross-functional project teams.
- Execute and monitor critical processes supporting production areas.
- Extensive experience with the following: upstream, downstream, and solution preparation equipment.
- Ability to contribute to the development of new concepts, techniques, and standards.
- Assist Facilities and Engineering personnel as necessary on equipment maintenance and calibration.
- Provide support to cross-functional teams to meet production or timeline demands.
- Demonstrate understanding in scientific concepts, technical operations, safety, and Good Manufacturing Practice.
- Adhere to Quality standards and learn and comply with regulatory requirements.
- Provide suggestions for process optimization and efficiency, where applicable.
- Write standard operating procedures (SOP's) and other documents as necessary
- Complete manufacturing documents such as batch records, logbooks.
- Assist in the execution of validation protocols.
- Ensure the completeness and accuracy of manufacturing documentation per approved procedures.
- Identify and support the implementation of process efficiencies and areas for improvement.
- Ensures solutions are consistent with organization's objectives.
- Demonstrate ability to perform all process steps and/or support production operations.
- Ability to generate SOPs for equipment and procedures used in the manufacture of biological products.
- Leads by example, keeping in mind organizational values, policies and goals. Develops people and team coaching and collaboration.
- Proactively partners with Human Resources to attract and retain top talent and takes an active role in ensuring new employee onboarding is a success.
- Other duties as assigned.
The Candidate:
- Masters' degree in a Scientific, Engineering or Biotech field with 6 - 8 years' experience with upstream (fermentation/bioreactor) biologic production processes under GMP compliance recommended.
- OR
- Bachelor's degree in a Scientific, Engineering or Biotech field with 8 - 10 years' experience with upstream (fermentation/bioreactor) biologic production processes under GMP compliance recommended.
- 3-4 years of progressive Leadership experience, experience with Performance Management, Goal Setting and Managing through Conflict.
- Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, GM Excellence, and GROW) may be considered in place of external experience.
- Proficient knowledge and ability to apply scientific principles utilized to solve operational, as well as routine production tasks.
- Proficient knowledge of documentation including comprehension, review & establishing Batch Production Records, SOP's, deviation & summary reports.
- Actively pursues learning of required skills, new skills, and new equipment.
- Possesses proficient equipment understanding, including understanding equipment function and application.
- Creative thinking with the ability to multi-task
- Commitment to ongoing professional development
- Team player who thrives in collaborative environments and revels in team success.
- Solid communication skills across technical and non-technical audiences and the ability to create and communicate complex concepts and analyses in easy-to-understand ways.
Position Benefits:
- Defined career path and annual performance review and feedback process
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
- 152 hours of paid time off annually + 8 paid holidays
- Competitive salary with yearly bonus potential
- Community engagement and green initiatives
- Generous 401K match and Paid Time Off accrual
- Medical, dental and vision benefits effective day one of employment
- Tuition Reimbursement
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.
Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
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 . 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.
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