Specialist II, Manufacturing Technical Operations

Catalent - Severn, MD

Full-time - Mid Level

Severn, MD

Chemical Manufacturing

About the position

The Specialist II, Manufacturing Technical Operations (MTO) position is based in our FDA-licensed, state-of-the-art CGMP manufacturing facility located on the Harmans/BWI campus. This facility is dedicated to the production of Gene Therapies and is strategically situated just 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from Baltimore. The campus features two manufacturing facilities, with the first facility housing approximately 200,000 sq. ft. of space that includes 10 CGMP manufacturing suites, fill/finish areas, central services, testing labs, and a warehouse. The second facility, currently under development, will add 8 additional CGMP manufacturing suites and cold storage warehousing, further enhancing our capabilities to support Phase 3 through commercial manufacturing of advanced therapeutic products, including AAV and other viral vector-based therapies and vaccines. In this role, the Specialist II, MTO will play a critical part in supporting Manufacturing Associates to ensure adherence to batch record review and disposition schedules, which are essential for meeting lot release dates. The Specialist will be responsible for executing root cause investigations, authoring deviations, driving continuous improvement initiatives, and revising GMP documents such as Standard Operating Procedures (SOPs) and Manufacturing batch records. This position requires a full-time on-site presence, emphasizing the importance of collaboration and communication within the manufacturing environment. The Specialist II will initiate Quality Records and conduct deviation investigations that align with both industry standards and Catalent's expectations. This includes leading investigations, performing root cause analysis, and assessing product impact with input from various departments. The role also involves developing, executing, and overseeing Corrective and Preventive Actions (CAPAs), ensuring that investigations are technically sound and meet quality expectations. The Specialist will support technology transfer and process monitoring, manage revisions of manufacturing documents, and lead or support Continuous Improvement projects. Additionally, the Specialist will be responsible for real-time responses to operational deviations, data gathering, trending, and presentation to support investigations, as well as participating in training activities and managing individual training plans.

Responsibilities

• Initiate Quality Records and conduct deviation investigations that meet both Industry and Catalent expectations.
• Lead or manage investigations including root cause analysis and assess product impact using input from various departments.
• Develop, execute and oversee CAPAs.
• Provide technical leadership to ensure product and process understanding is sufficient for investigating deviations.
• Support technology transfer and process monitoring as needed.
• Monitor critical process parameters with the team.
• Revise and manage manufacturing documents such as Batch Records and SOPs.
• Lead or support Continuous Improvement projects.
• Conduct data gathering, trending, and data presentation as needed to support investigations.
• Respond in real-time on the manufacturing floor to operational deviations by gathering information and completing an initial event report.
• Actively participate in training activities and manage individual training plans.
• Perform other duties as assigned.

Requirements

• Masters' degree in a Scientific, Engineering or Biotech field with 4 years' experience in biopharmaceutical manufacturing processing in a GMP compliance environment.
• Bachelor's degree in a Scientific, Engineering or Biotech field with 5 years' experience in biopharmaceutical manufacturing processing in a GMP compliance environment.
• Associate Degree or HS Diploma with 6-8 years' experience in biopharmaceutical manufacturing processing in a GMP compliance environment.
• 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 is 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.
• Familiarity 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.

Nice-to-haves

• Experience in a fast-paced manufacturing environment.
• Familiarity with advanced therapeutic products and processes.

Benefits

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Potential for career growth on an expanding team
• 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 Reimbursement