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Manufacturing Manager (PM Shift) - Severn Maryland
Company: Disability Solutions
Location: Severn, Maryland
Posted On: 02/06/2025
Manager, Manufacturing Position Summary: ----Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.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--. 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 Manufacturing Manager is accountable for leading multiple teams to execute procedures-- for downstream (purification)manufacturing and support area of manufacturing using SOP's and batch records.-- Operating production equipment for purification-- that-- may-- include-- process-- monitoring, purification and formulation. This position is accountable for continuous improvement of the operations and ensuring all team members are trained and training is completed on time This is a full-time on-site position, 7pm-7amCatalent is committed to a Patient First culture through excellence in quality and--compliance, and to the safety of every patient, consumer, and Catalent employee.--$10,000 sign on bonusThe Role: -- - Manage and improve the purification operations of Contract Manufacturing Facility.
- Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines.
- Establish a continuous improvement plan to achieve excellence in accordance with The Catalent Way (TCW); deploy the plan and coach others on the journey.
- Build effective teams that apply their diverse skills and perspectives to achieve common goals.
- Drive engagement and create a culture where employees are motivated to do their best.
- Ensure quality culture through the continuous pursuit of right first-time performance.
- Understand company goals and practices and apply them when resolving a variety of problems.
- Coordinate with production supervisors and project managers to execute production campaigns on-time.
- Ensure batches adhere to established Quality standards.
- Write and/or approve manufacturing documentation, including validation protocols, SOPs, and master batch records.
- Review client processes for compatibility with plant capabilities and GMP requirements.
- Work with client representatives, Process Development, and technical support to transfer manufacturing processes.
- Coordinate with other departments to schedule work in processing and support areas or work that affects processing and support areas.
- Identify and maintain relationships with quality vendors of supplies, instruments, and equipment.
- Identify processing technologies and capabilities to add to the Catalent portfolio.
- Work with QA to investigate and resolve nonconformance's.
- Other duties as assigned.The Candidate:
- Masters' degree in a Scientific, Engineering or Biotech field with 6 -8 years' experience with upstream (purification) biologic production processes under GMP compliance recommended.Experience with chromatography equipment, columns, TFF, CIP procedures and of processes to purify bulk proteins, antibodies, etc. (HIC, IEX, Affinity)
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- 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.
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- Associate'sDegree with 10 -12 years' experience in biologics production recommended.
- 3 years of Progressive Leadership experience, experience with Performance Management, Goal Setting and Managing through Conflict.
- One (1) year of demonstrated leadership experience (Lead role) at a Catalent site will be considered.
- 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.The anticipated salary range for this position in Maryland is $118,720- $163,240 ---plus annual bonus, when eligible.-- The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.Why you should join Catalent:
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