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Principal Process Engineer - Manufacturing Sciences & Technology, Upstream

Summary

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 in Kansas City, MO and Research Triangle Park, NC, 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.

Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast growing business, backed by a global public company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer’s.

The Manufacturing Science and Technology subject matter expert will oversee technical support of Manufacturing, including the technology transfer between external clients or Process Development and Manufacturing.

The position will work alongside a group of engineers, scientists and other colleagues to drive the facility fit and technical transfer of mammalian biologic processes. The position will also include responsibilities associated with the evaluation, alignment and recommendation of equipment and process improvements. This role will direct on-call and on-the-floor technical support to manufacturing. The SME will be responsible for the drafting and review of documentation, compilation and assessment of process data, and provide technical input for deviations investigations, change controls, and CAPAs. This position will be client facing and should possess the ability to work collaboratively with clients and internal cross-functional stakeholders to move projects forward.

This is a full-time on-site position, Monday – Friday 8am-4:30pm

($5,000 Sign-On Bonus Available)

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.

• Works cross functionally with Process Development, Manufacturing, Quality Assurance, Quality Control, Supply Chain, Project Management, Facilities and other departments to effectively transfer and maintain processes in the facility.

• Participates in and supports strategic alignment across Catalent Biologics sites and the Madison site.

• 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.

• Supports the building of business case(s) for process improvement projects

• 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.

• Responsible for motivating, coaching and developing coworkers as a subject matter expert.

• Perform other responsibilities to support group, site and network-based initiatives, as required.

• Other duties as assigned.

The Candidate

• PhD in Engineering, Biotechnology, or related field, with a minimum of 8 years of relevant experience; OR

• M.S./M.A. in Engineering, Biotechnology, or related field, with a minimum of 12 years of relevant experience; OR

• B.S./B.A. in Engineering, Biotechnology, or related field, with a minimum of 15 years of relevant experience.

• Experience with Upstream (mammalian cell culture) processes across cGMP biologics production scales.

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

• Experience in writing reports and documentation skills such as drafting and revising standard operating procedures, batch production records.

• Direct personnel and organizational group management experience, including mentoring and training staff members cross-functionally.

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

• Demonstrated working knowledge of Tech Transfer between Development and Manufacturing.

• Demonstrated understanding of multiple applicable techniques, including purification, buffer preparation, operation and troubleshooting of stirred vessel bioreactors, incubators, chromatography columns and processing, and filtration apparatuses.

Physical Requirements

• Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening.

• Occasional stooping, kneeling, crouching, bending, carrying, grasping.

• Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds.

• Must comply with EHS responsibilities for the position.

• Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste. Safety procedures must be followed to minimize exposure, including proper use of PPE (personal protective equipment) and clean room gowning.

• Working conditions will be Heating Ventilation and Air Conditioned controlled.

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 and Paid Time Off accrual

• 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.

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) .