Specialist II, Manufacturing Technical Operations

Company: Disability Solutions
Location: Severn
Posted on: August 31, 2024

Job Description:

Specialist II, MTOSummary: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 Specialist II, MTO will provide support to Manufacturing Associates to meet batch record review/disposition schedule to adhere to lot release dates. The Specialist II, MTO will be responsible for, executing root cause investigations, owning/authoring deviations, driving continuous improvement efforts and other quality reports and revising GMP documents such as SOPs and Manufacturing batch records.This is a full-time on-site positionCatalent 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:

• Initiates Quality Records and conducts deviation investigations that meeting both Industry and Catalent expectations.
• Leads or manage investigations including root cause analysis and assesses product impact using input from various departments.
• Develops, executes and oversees CAPAs.
• Technical leadership will be required to ensure that product and process understanding is sufficient to investigate deviations, that investigations are technically sound, meet quality expectations, and that corrective actions are effective.
• Supports Tech transfer and process monitoring support as needed.
• Works with the team to monitor critical process parameters
• Revision and management of manufacturing documents such as Batch Records and SOPs
• Leads or supports Continuous Improvement projects
• Conducts data gathering, trending, and data presentation as needed to support investigations
• Responsible for real time, on the floor response in support of operational deviations by gathering information and completing an initial event report.
• Actively participates in training activities, managing individual training plan.
• Other duties as assigned.The Candidate:
  • Masters' degree in a Scientific, Engineering or Biotech field with 4 years' experience in biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field)OR
    • Bachelor's degree in a Scientific, Engineering or Biotech field with 5 years' experience in biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field).OR
      • Associate Degree or HS Diploma with 6-8 years' experience in biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field)
        • Knowledge of GMP's, FDA regulations and documentation procedures required
        • Experience in quality systems regulations
        • 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 a plus
        • Previous experience in process deviation investigations and remediation, including major and/or critical deviations
        • Previous experience authoring and/or revising technical documents
        • Demonstrated ability to work effectively cross-functionally, lead teams and implement project plans on time and on budget
        • Excellent communication and technical writing skills
        • Ability to support and/or lead system troubleshooting efforts
        • Familiar with Lean Six Sigma Methodologies and proven analytical/ problem solving capabilities.
        • 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
        • On-site presence, as the role requires time on the manufacturing floor and cross-functional collaborationPosition 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.--Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.------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 .

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