Manufacturing Sciences & Technology Engineer III

The Manufacturing Sciences & Technology (MS&T) Engineer III will support Manufacturing Operations in the successful transfer and startup of clinical drug substance and drug product cGMP manufacturing operations at Catalent Gene Therapy. The MS&T Engineer III is actively engaged in the technical transfer of client and Catalent Process Development information for implementation of cGMP processes. The individual will serve as a subject matter expert (SME) for biologic Upstream Processes and/or Downstream Processes. Success in this position requires the ability to work hands on in a cleanroom, and the ability to collaborate in a cross-functional, fast paced environment.

Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. 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:

• Work with GMP manufacturing and Process Development in one or more of the following areas: cell culture, purification and/or fill & finish
• Support client projects as the MS&T Lead for tech transfer of projects from Paragon Process
• Development and external clients into GMP manufacturing.
• Author tech transfer documents, including detailed process descriptions and scale-up documents
• Author Master Production Records and SOPs to support GMP manufacturing projects
• Working with GMP Manufacturing as an on-the-floor Subject Matter Expert (SME)
• Working closely with project management to ensure MS&T project milestones are achieved;
• Assist with training GMP Manufacturing staff on Client processes
• Collect and trend process data for external (client) and internal review, and for support of client needs.
• Serve as team leader for process and product investigations and author investigation reports
• Assist Clients in regulatory filing support as a process SME

The candidate:

• B.S. Chemical Engineering, Chemistry, Biology, Life Sciences or related field with 4 - 8 years of experience in the pharmaceutical or biotechnology industry -OR-
• M.S. Chemical Engineering, Chemistry, Biology, Life Sciences or related field with 2+ years of experience
• Knowledge/expertise relevant to protein and virus manufacturing in a cGMP environment.
• Experience in one or more of the following manufacturing areas: cell and/or microbial culture, protein purification and fill/finish
• Experience in a CMO environment or in a similar client-customer based work environment a plus

Why you should join Catalent:

• Competitive medical benefits and 401K
• 152 hours 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.

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.

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.