Senior Manager, Manufacturing Technical Operations

Company: Disability Solutions
Location: Severn
Posted on: October 19, 2024

Job Description:

Senior Manager - Manufacturing Technical Operations (MTO)Summary: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 Senior Manager, Manufacturing Technical Operations (MTO) is responsible for oversight and leadership of MTO group that supports manufacturing operations at Catalent.-- The Manufacturing Technical Operations group functions include investigations, deviations, continuous improvement (change controls, CAPAs) operational excellence (major projects), technology transfer support, manufacturing document generation & revision, bill of materials (BOM) management, operations data analytics & metrics, manufacturing finite scheduling and manufacturing suite & readiness.This is a full-time on-site position, M-F 8am-5pmCatalent 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:

• Build, lead and manage the MTO group to support on-going and future manufacturing operations ensuring staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines--
• Manage the interface of the MTO group with internal stakeholders and clients through proactive communication and accountability for on-time project/work completion; Interacts with clients on projects and presentations; Oversees and coaches team member client interactions
• Oversee daily activity for the group to ensure quality results Performance management for direct reports and drives timely completion of major manufacturing investigations and deviations and subsequent CAPAs
• Oversight and coordination of manufacturing continuous improvement (e.g. CAPAs, Change Controls) and operational excellence activities; establish and manage a yearly slate of improvement projects with measurable results aligned with the site's objectives
• Supports technology transfer teams led by MS&T providing the manufacturing representative or coordinating manufacturing representation
• Provides effective oversight and coordination of manufacturing document generation & revision, bill of materials (BOM) management, operations data analytics & metrics, manufacturing finite scheduling and manufacturing suite & readiness to ensure timely completion
• Other duties as assignedThe Candidate:
  • Masters' degree in a Scientific, Engineering or Biotech field with 5-7 years' experience in cGMP production &/or quality experience, with knowledge and understanding of process, documentation requirements and activities - OR -
  • Bachelor's degree in a Scientific, Engineering or Biotech field with 8+ years' experience in cGMP production &/or quality experience, with knowledge and understanding of process, documentation requirements and activities NOTE: 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
  • Previous management and leadership experience and will promote a positive experience for employees
  • Knowledge of GMP's, FDA regulations and documentation procedures required
  • Experience in quality systems regulations; Previous experience in process deviation investigations and remediation; to include authoring and/or revising technical documents
  • Previous experience operating equipment such as: incubators, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment
  • Demonstrated ability to work effectively cross-functionally, lead teams and implement project plans on time and on budget
  • Excellent communication and technical writing skills
  • 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
  • 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 experiencePosition Benefits:
    • Defined career path and annual performance review and feedback process--
    • 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, Sterling , Senior Manager, Manufacturing Technical Operations, Executive , Severn, Virginia