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Manufacturing Specialist - Severn Maryland
Company: Disability Solutions
Location: Severn, Maryland
Posted On: 02/02/2025
Manufacturing SpecialistSummary:Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.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 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. No remote or hybrid work available. 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: - Provides scheduling support and operational oversight to day-to-day manufacturing production.
- Creates and reports performance success metrics.
- 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 assessment of the larger manufacturing organization.
- Represents the manufacturing organization in defining user requirements and practical implementation of eBRs and integrated systems.
- Provides technical leadership 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 specialized trainings to assist in technical knowledge transfer.
- Assists manufacturing associates to meet batch record review/disposition schedule to adhere to lot release dates.
- Identifies root cause, recommends and implements actions.
- 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 manufacturing 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.
- Participates in training activities, managing individual training plan.
- Performs other duties as assigned.The Candidate:
- Master's degree in a Scientific, Engineering or Biotech field with 2 years of 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 4 years of experience in biopharmaceutical 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 biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field)
- Strong analytical and problem-solving skills.
- Proficiency in computer/business systems applications.
- Knowledge of GMPs, FDA regulations, and documentation procedures.
- Experience with biopharmaceutical equipment (e.g., bioreactors, chromatography skids).
- Experience in process deviation investigations and technical document authoring.
- Experience with MES/EMS/MRP/LIMS/LMS systems (basic programming skills a plus).
- Excellent communication, teamwork, and leadership skills.The anticipated salary range for this position in Maryland is $84,000 to $120,000 plus --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.Position Benefits:
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