Manager, Manufacturing Technical Operations
About The Position
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.
Requirements
- Master’s degree in a Scientific, Engineering, or Biotech field with 6 years of experience in current Good Manufacturing Practice production and/or quality experience, with knowledge and understanding of process, documentation requirements, and activities; or Bachelor’s degree in a Scientific, Engineering, or Biotech field with 8 years of experience in current Good Manufacturing Practice production and/or quality experience, with knowledge and understanding of process, documentation requirements, and activities
- Minimum 3 years of progressive leadership experience, including performance management and people development
- Knowledge of Good Manufacturing Practices, Food and Drug Administration regulations, and documentation procedures required
- Experience in quality systems regulations; previous experience in process deviation investigations and remediation, including authoring and/or revising technical documents
- Demonstrated ability to work effectively cross-functionally, lead teams, and implement project plans on time and on budget
- Excellent communication and technical writing skills
- 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
Nice To Haves
- Previous experience operating equipment such as incubators, single-use bioreactors, depth filtration skids, tangential flow filtration skids, chromatography skids, single-use mixers, and in-process testing equipment
- Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.
Responsibilities
- Build, lead, and manage the Manufacturing Technical Operations group to support ongoing and future manufacturing operations, ensuring staff are fully trained on all current Good Manufacturing Practice operations and documentation while adhering to safety guidelines
- Manage the interface of the group with internal stakeholders and clients through proactive communication and accountability for on-time project and work completion; interact with clients on projects and presentations; oversee and coach team member client interactions
- Oversee daily activities for the group to ensure quality results, including performance management for direct reports and driving timely completion of major manufacturing investigations, deviations, and subsequent Corrective and Preventive Actions
- Provide oversight and coordination of manufacturing continuous improvement activities such as Corrective and Preventive Actions and Change Controls, and operational excellence initiatives; establish and manage a yearly slate of improvement projects with measurable results aligned with site objectives
- Support technology transfer teams led by Manufacturing Science and Technology by providing or coordinating manufacturing representation
- Provide effective oversight and coordination of manufacturing document generation and revision, bill of materials management, operations data analytics and metrics, manufacturing finite scheduling, and manufacturing suite readiness to ensure timely completion
- Other duties as assigned
Benefits
- Competitive paid time off plus 8 paid holidays
- Medical, dental, and vision benefits effective day one of employment
- Tuition reimbursement
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What This Job Offers
Job Type
Full-time
Career Level
Manager
