Specialist III, Manufacturing Technical Operations

Manufacturing Technical Operations Specialist III 

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 Baltimore location. 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 III, MTO will provide support to Manufacturing Associates to meet batch record review/disposition schedule to adhere to lot release dates. The Specialist III, 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 position, M-F 8am-5pm

Catalent 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 6 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 8 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 8 -10 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 analytic