Process Engineer - Manufacturing Science and Technology, Downstream

　　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, mRNA, new modalities, etc.), equipment, consumables, technical writing, and drug substance lifecycle management. 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, and continuous improvement.

　　The Process Engineer - Manufacturing Science and Technology, Downstream , will provide 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 providing technical input for deviation 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 fulltime role working Days; Monday – 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:

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

　　Work 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.

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

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

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

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

　　Act 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.

　　Client Interactions/Project Leadership: Participate in client meetings offering technical support and leading the project.

　　Other duties as assigned

　　The Candidate:

　　Associate’s degree in a STEM discipline and >6 years related experience, OR

　　Bachelor's degree in a STEM discipline and 3-6 years related experience, OR

　　Master’s degree in a STEM discipline and 0-2 years related experience

　　Experience in Tech transfers preferred

　　Technology Transfer (Downstream, mRNA & Molecular Therapies):

　　SME of Downstream (e.g., depth filtration/clarification, chromatography, tangential flow filtration, viral filtration, BDS fill, etc.) molecular therapeutics manufacturing (mRNA or new modality) processes across cGMP biologics production scales

　　Experience in facility fit, process scaling and technology transfer

　　Why you should join Catalent:

　　Fast tracked career growth, with annual performance review and feedback process

　　Competitive base salary with other compensation incentives including yearly incentive plan

　　Medical, Dental, Vision, and 401K are all offered on day one of employment

　　19 days of Paid Time Off (152 hours PTO) + 8 paid holidays

　　Onsite gym, Catalent corporate discount perks, paid volunteer time off program and other benefits too numerous to mention!

　　Defined career path and annual performance review and feedback process

　　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) .