Process Engineer - Manufacturing Sciences & Technology, Downstream

Summary

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 Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.

The Manufacturing Sciences and Technology (MS&T) department’s primary function is to serve as an agile technical services team to support process & technology transfer (e.g., mAbs, fusion proteins, enzymes, mRNA, new modalities, etc.), process readiness and execution support related to documentation, equipment, consumables and materials, and technical writing. The MS&T organization supports the Madison facility as well as the Catalent Biologic’s network through client- facing support, on-the-floor or on-call technical coverage, as well as continuous improvement and site strategy projects.

The Technology Transfer groups (Upstream and Downstream) are the technical liaisons between Process Development (internal or external) and at-scale GMP manufacturing relating to process transfer. This function includes drafting and supporting required batch documentation (i.e., gap assessments, reports, batch records, product impact), as well as process modeling and facility fit including initial bill-of-material development.

This is a full-time role working Days; Monday – Friday 8sm-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:

• Support technology transfer of processes into manufacturing for both internally and externally developed processes.

• Oversee technical support of Manufacturing, including the technology transfer between external clients or Process Development and Manufacturing.

• Work alongside a group of engineers, scientists, and other colleagues to drive the facility fit and technical transfer of biologic processes.

• Perform responsibilities associated with the evaluation, alignment, and recommendation of equipment and process improvements.

• Works closely with manufacturing to author appropriate batch documentation and provide technical and strategic oversight associated with GMP manufacturing.

• Leads and/or supports the compilation of process data, including communicating project status, trend identification, and delivering internal or client presentations.

• Evaluates existing processes and identifies process or equipment improvements to advance efficiency, consistency, and competitiveness within the market.

• Authors and reviews documents including batch production records, tech transfer reports, bill of materials, process descriptions, project reports, engineering specifications and summary reports.

• Acts as the lead for technical support of risk assessments, gap analysis, deviations, change controls, and CAPAs including determination of product or process impact, root-cause analysis, and corrective action identification.

• Other duties as assigned.

The Candidate:

• Associate's degree in a STEM discipline and 6+ years of related experience, OR

• Bachelor's degree in a STEM discipline with 3+ years of related experience, OR

• Master’s degree in a STEM discipline with 0+ years of related experience

• Experience in investigating and closing deviations, OOS, and CAPAs preferred.

• Experience drafting and revising standard operating procedures, batch production records and reports preferred.

• Experience working on late phase, process performance qualification and commercial programs is a plus

• Downstream experience (e.g., depth filtration/clarification, chromatography, tangential flow filtration, viral filtration, BDS fill, etc.) manufacturing processes across cGMP biologics production scales required.

• Experience in facility fit, process scaling and technology transfer preferred

Why you should join Catalent:

• Defined career path and annual performance review and feedback process

• Diverse, inclusive culture

• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

• 152 hours of paid time off annually + 8 paid holidays

• Competitive salary with yearly bonus potential

• Community engagement and green initiatives

• Generous 401K match

• Medical, dental and vision benefits effective day one of employment

• 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 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) .