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Supervisor, Upstream Manufacturing (PM Shift) - Severn Maryland
Company: Disability Solutions
Location: Severn, Maryland
Posted On: 11/15/2024
Supervisor, ManufacturingSummary: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 Supervisor is accountable for leading teams to execute procedures for upstream manufacturing and support area of manufacturing using SOP's and batch records.-- Operating production equipment for upstream processing that may include process monitoring, media prep and harvesting.-- This position is accountable for ensuring all team members are trained and training is completed on time prior to entering the production floor.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.--The Role: - Supervision of manufacturing processes and personnel
- Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines--
- 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.
- Oversee daily activity for the group to ensure quality results Performance management for direct reports.
- 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.
- Conduct performance reviews of manufacturing associates.
- 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 mammalian and microbial production facilities
- Extensive experience with the following:-- large-scale centrifuges, washers, autoclaves
- 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
- Ability to accurately analyzes and processes scientific data
- 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 upstream 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 4 - 6 years' experience with upstream (fermentation/bioreactor) biologic production processes under GMP compliance.
- OR
- Bachelor's degree in a Scientific, Engineering or Biotech field with 6 - 8 years' experience with upstream (fermentation/bioreactor) biologic production processes under GMP compliance.
- OR
- HS Diploma or Associate Degree with 8 - 10 years' experience with upstream (fermentation/bioreactor) biologic production processes under GMP compliance.
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- 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.
- Experience in mammalian or microbrial cell culture a required.
- Solid experience with the following: large-scale centrifuges, washers, autoclaves
- 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 $93,280- $128,260 plus shift differential and 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.Position Benefits:
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