Catalent Pharma Solutions Principal Engineer, MS&T Technology Transfer in Madison, Wisconsin
Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here (http://www.catalent.com/index.php/about-us/Catalent-Careers2)
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.
II. Specific Duties, Activities, and Responsibilities:
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.
III. Typical Position Requirements:
PhD in Engineering, Biotechnology, or related field, with minimum of 8 years of relevant experience; or
M.S./M.A. in Engineering, Biotechnology, or related field, with minimum of 12 years of relevant experience; or
B.S./B.A. in Engineering, Biotechnology, or related field, with minimum of 15 years of relevant experience.
Experience with Upstream (mammalian cell culture) and / or Downstream (chromatography, tangential flow filtration, etc.) processes across cGMP biologics production scales
Experience in facility fit, process scaling and technology transfer
Experience in report and documentation skills
Experience with statistical techniques for data analysis and reporting
Direct personnel and organizational group management experience, including mentoring and training staff members cross-functionally
Experience in investigating and closing deviations, OOS, and CAPAs
Experience drafting and revising standard operating procedures, batch production records and reports
Experience with operating and troubleshooting process equipment, including single-use systems and consumables
Experience working on late phase, process performance qualification and commercial programs is a plus
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 www.catalent.com/careers to explore career opportunities.
C atalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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 firstname.lastname@example.org for us to investigate with local authorities.
Catalent = Catalyst + Talent
Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!
personal initiative. dynamic pace. meaningful work.
Catalent is the perfect place to grow your career if…
You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).
You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!
You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.
You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.
You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking (https://catalent.wd1.myworkdayjobs.com/External) for YOU!
See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here (https://www.youtube.com/playlist?list=PLuUGqEwwnH7hBwFlrsfSOH_raQHu4hOBK) .