Senior Manufacturing Specialist

　　M-F 8am-5pm

　　Summary

　　The Senior 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.

　　Catalent is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Catalent Cell and Gene Therapy provides process development, process characterization, and GMP manufacturing services to industry leaders utilizing novel technologies to produce state-of-the-art vaccines and gene therapies. As a Catalent employee, you will actively contribute to delivery of services to our clients and impact the well-being of their patients.

　　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, recommended and implement 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

　　Masters’ degree in a Scientific, Engineering or Biotech field with 2-4 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 5-6 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)

　　Familiar with LSS methodologies and proven analytical/ problem solving capabilities.

　　Knowledge of eBR and integration with manufacturing execution (MES) and quality management (QMS) systems.

　　Proficiency in computer/business systems applications.

　　Advanced experience in Microsoft Excel and managing large data sets.

　　Experience with GMP’s, FDA regulations and documentation procedures required.

　　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.

　　Experience as a MES, EMS, MRP, LIMS, or LMS administrative user and basic programming skills.

　　Demonstrated ability to work effectively cross-functionally, lead teams and implement project plans on time and on budget.

　　Experience implementing and leading Continuous Improvement projects.

　　P osition Benefits:

　　Opportunity to gain experience in the cutting-edge gene therapy space and help to develop critical lifesaving therapies for our clients

　　19 days PTO & 8 Holidays

　　Medical, Dental & Vision Benefits and 401k

　　Employee Stock Purchase Plan

　　Tuition Reimbursement

　　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.

　　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 Catalent Careers (https://careers.catalent.com/us/en) 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 [email protected] . 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 [email protected] for us to investigate with local authorities.

　　California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .