Director of Manufacturing, Commercial - Severn Maryland

Company: Disability Solutions
Location: Severn, Maryland
Posted On: 02/06/2025

Title: Director Manufacturing, CommercialLocation: Harmans, MDPOSITION SUMMARY The Director of Manufacturing, Commercial is responsible for establishing the vision for excellence and leading the manufacturing teams to realize the vision.-- The incumbent will lead a team of managers and supervisors while overseeing the GMP manufacturing process.-- Through the broad knowledge of theories and lean principles, the director solves operational issues and ensures execution of routine tasks in the production of gene therapy products.The Role:

• Cascade the site strategy through the commercial manufacturing organization and drive continuous improvement to exceed annual targets for safety, quality, and productivity.
• Recruit, train, and develop staff supporting operations. Ensure aggressive developmental plans for staff and act as a coach for lean and professional development.-- Ensure compliance to requiring company compliance training.--
• Partner with site continuous improvement resources to lead commercial manufacturing improvement following The Catalent Way.--
• Interact cross-functionally with Operations, Facilities, Quality Assurance, Quality Control, MS&T and other internal and external functions to support successful batch production.
• Assure accurate consumption and tracking of GMP materials.
• Provide general supervision for cGMP suite cleaning and waste removal, stocking of consumables, and movement of raw materials and solutions within the cGMP suites.
• Provide direct supervision, training, and hands-on support of production staff in the operation of equipment to support preclinical, clinical phase, and commercial launch batches of all materials. Coordinate and supervise department change-over activities. Serve as the equipment and suite owner to coordinate routine suite and equipment maintenance, calibration, and validation with appropriate internal departments.
• Coordinate the preparation/revision of master batch records, SOPs, and review/close-out all cGMP documents, including equipment and process deviations for each campaign.
• Assist in troubleshooting equipment issues and batch/material related deviations. Provide timely reporting, investigation, and resolution of manufacturing process/product deviations, change controls, and commitments.
• Ensure adherence of operations to cGMP guidelines as well as industry safety standards and OSHA guidelinesThe Candidate:
  • Bachelor's degree in Engineering or Science discipline
  • 10+ years of relevant experience with 8+years of direct management experience
  • Demonstrated proficiency in continuous improvement methodologies (lean, six sigma, other).
  • Minimum of 10 years in a multi-discipline cGMP production environment, initiating, scheduling, and managing product manufacturing functions.
  • Knowledgeable in operation of cell culture and single use bioreactors.
  • Knowledgeable in cGMP equipment validation, trouble shooting, and maintenance.
  • Ability to identify, investigate, and solve process, product and equipment problems
  • Strong working knowledge of USP and EU.--
  • Excellent interpersonal skills.
  • Team player who can excel in a "hands-on" entrepreneurial environment.
  • Ability to train and develop subordinate technical staff.
  • Fitness for the use of chemical safety respirators for solution handling required
  • CDMO or CMO experience preferred.Knowledge/Skills Requirements:
    • Must be able to communicate effectively with others (both verbally and in writing)
    • Skilled in strategy deployment and continuous improvement
    • Creative individual with excellent problem solving and trouble shooting skills
    • Strong focus on responsiveness, ability to multi-task, attention to detail, effective problem-solving skills, consistent follow-up and ability to make timely and sound decisions (Quality and Business)
    • Must be able to prioritize
    • Must demonstrate patience, professionalism and ability to effectively interact with staff and management alike (transversely collaborative) across functional groups and levels
    • Ability to work effectively under pressure to meet deadlinesWhy You Should Join Catalent
      • Defined career path and annua 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
      • Dynamic, fast-paced work environment.
      • 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 . More...

            

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