Manufacturing Specialist

Manufacturing Specialist – Fill/Finish

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 Manufacturing Specialist supports the day-to-day operations of the manufacturing process as a Subject Matter Expert, providing oversight and guidance to the tactical operations. Additionally, this function integrates continuous improvement and technical knowledge transfer into the larger manufacturing organization by acting as the liaison between manufacturing and the site CI and MS&T organizations. The incumbent reports into the Manufacturing Control Center and provides support for lean Six Sigma (LSS) problem solving, value stream management, continuous improvement assessment process, electronic systems integration, tech transfer, manufacturing training, RCA / CAPA, and quality remediations.

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:

• Provides scheduling support and operational oversight to day-to-day manufacturing production.
• Tracks, trends, analyzes and reports performance parameters and in-process controls.
• Works with the CI, MS&T, and QA functions to apply LSS problem-solving and value stream management methods.
• Oversees the process for ongoing CI assessments in the fill/finish organization.
• Represents the manufacturing organization in defining user requirements and practical implementation of eBRs and integrated systems.
• Provides technical leadership over fill/finish processes 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.
• Develops on job trainings for fill/finish manufacturing associates. Participates in training activities, managing individual training plan.
• Assists manufacturing associates to meet batch record review/disposition schedule to adhere to lot release dates.
• Identifies root cause, and recommends and implements actions and participates in quality remediation plans.
• Executing root cause investigations, owning/authoring deviations, CAPAs and CC
• Drives continuous improvement efforts and other quality reports and revising GMP documents such as SOPs and Manufacturing batch records.
• Participates and represents fill/finish in cross-functional efforts for deviation reduction.
• Conducts data gathering, trending, and data presentation as needed to support investigations. Provides real time, on the floor response in support of operational deviations by gathering information and completing an initial event report.
• Performs other duties as assigned.

The Candidate:

• Master’s degree in a Scientific, Engineering or Biotech field with 2 years of experience in aseptic filling 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 4 years of experience in aseptic filling manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field).  OR
• Associate’s degree or HS Diploma with 5-6 years of experience in aseptic filling manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field)
• Knowledge of EU Annex 1, GMP’s, FDA regulations and documentation procedures required.
• Previous experience operating equipment such as: peristaltic or piston pump aseptic fillers, automated packaging lines, semi-automated visual inspection stations, autoclaves, parts washers, and filter integrity testers.
• Previous experience in process deviation investigations and Previous experience authoring and/or revising technical documents.
• Experience as a MES, EMS, MRP, LIMS, or LMS user and basic programming skills a plus.
• Demonstrated ability to work effectively cross-functionally, lead teams and implement project plans on time and on budget.
• Excellent communication and technical writing skills and can support and/or lead system troubleshooting efforts.
• 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.

The anticipated salary range for this position in Maryland is $93,000 to $125,000 and annual bonus, when eligible.  The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.

Why you should Join Catalent:

• Potential for career growth within an expanding team.
• Defined career path and annual performance review & feedback process.
• Cross-functional exposure to other areas within the organization.
• Medical, Dental, Vision, and 401K are all offered from day one of employment.
• Employee Stock Purchase Plan.
• 152 hours of PTO and 8 paid holidays.

Catalent 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 Catalent Careers 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 DisabilityAccommodations@catalent.com. 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.

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