Supervisor, Manufacturing (Downstream)

Company: Disability Solutions
Location: Severn
Posted on: October 25, 2024

Job Description:

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.
      • 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.Position Benefits:
        • Defined career path and annual performance review and feedback process--
        • Diverse, inclusive culture--
        • 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 ReimbursementCatalent 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.--personal initiative. dynamic pace. meaningful work.Visit 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.Important Security Notice to U.S. Job Seekers:Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice .

Keywords: Disability Solutions, Rockville , Supervisor, Manufacturing (Downstream), Other , Severn, Maryland