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Supervisor, Downstream Manufacturing (PM Shift) - Severn Maryland
Company: Disability Solutions
Location: Severn, Maryland
Posted On: 11/21/2024
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.
- Extensive experience with chromatography equipment, columns, TFF, CIP procedures and of processes to purify bulk proteins, antibodies, etc. (HIC, IEX, Affinity)----
- Coordinate with other production supervisors, managers, and project managers to execute production campaigns on-time.
- Ensure batches adhere to established Quality standards.
- Lead initiation and closure of deviations; may serve as the lead in the departmental investigation and be responsible for closing out deviations and CAPAs----
- Collaborate with MST and development groups to assist with tech-transfer, scale-up, and translation activities.
- GMP batch review and close-out with Quality Assurance group.
- 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 Downstream team.
- Represent the department to clients and on cross-functional project teams.
- Interface with Quality Control department to submit in-process samples and coordinate environmental monitoring during key process steps.
- Review GMP documentation and production records for accuracy.
- Interface with Quality Assurance group to ensure completeness of GMP documentation.
- Initiate non-conforming events and participate in investigations as requested
- Draft and revise official manufacturing documents, SOPs, Batch Records, Validation Protocols.
- Accurately follow SOP's for operating production equipment and performing processing steps
- Collaborate with engineering group to validate equipment for GMP production.
- 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 in downstream GMP production and purification including aseptic processing, chromatography, TFF, Final Formulation and buffer preparation processes under GMP compliance.OR
- Bachelor's degree in a Scientific, Engineering or Biotech field with 6 - 8 years' experience in downstream GMP production and purification including aseptic processing, chromatography, TFF, Final Formulation and buffer preparation processes under GMP compliance.OR
- Associate Degree or HS Diploma with 8 - 10 years' experience in downstream GMP production and purification including aseptic processing, chromatography, TFF, Final Formulation and buffer preparation processes under GMP compliance.
- 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.
- Experience in Pharma/Biotech or other cGMP manufacturing environment required
- Knowledge of GMP's, FDA regulations and documentation procedures required
- Proficient originality and application of standard engineering principles and methods in completing technical assignments.
- Work requires the application of standard engineering principles and methods to the solution of process/production problems.
- 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.
- Onsite work is required. No option for remote or hybrid work.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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