Specialist III, Manufacturing Technical Operations (MTO)

POSITION SUMMARY

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 Specialist III, MTO is responsible for the independent investigation, root cause determination, and development of appropriate corrective actions for deviations occurring during manufacturing operations at Catalent. They will interact with multiple company functional groups (I.e., QA, Manufacturing, QC) as well as having direct interactions with client representatives.

This is a full time onsite role; 8am-5Monday – Friday

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 meet both Industry and Catalent’s expectations

• Leads or manage investigations including root cause analysis and assesses product impact using input from various departments

• 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

• Leads or supports Continuous Improvement projects

• Conducts data gathering, trending, and data presentation as needed to support investigations.

• 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’s 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 analytical/ problem solving capabilities.

• Creative thinking with the ability to multi-task

• Commitment to ongoing professional development

• 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

• On-site presence, as the role requires time on the manufacturing floor and cross-functional collaboration

Why You Should Join Catalent

• Competitive medical benefits and 401K

• 152 hours of PTO + 8 Paid Holidays

• Dynamic, fast-paced work environment

• Opportunity to work on Continuous Improvement Processes

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 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.

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 spam@catalent.com 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) .