|Date Posted||May 12, 2021|
|Address||726 Heartland Trail, Suite 100|
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
I. Position Overview:
The Manufacturing Science and Technology manager will lead a team in technical support of Manufacturing, including the technology transfer between external clients or Process Development and Manufacturing.
The position will lead a group of engineers, scientists and other direct reports to drive the facility fit and technical transfer of mammalian biologic processes, including the evaluation, alignment and recommendation of equipment and process improvements. This role will also direct on-call and on-the-floor technical support to manufacturing. The manager 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. The manager will be client facing and 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 maintaining a high performing team by hiring, training, motivating, evaluating, and developing staff.
- Perform other responsibilities to support group, site and network-based initiatives, as required.
III. Typical Position Requirements:
- PhD in Biotechnology, or related field, with minimum of 6 years of relevant experience; or
- M.S./M.A. in Biotechnology, or related field, with minimum of 10 years of relevant experience; or
- B.S./B.A. in Biotechnology, or related field, with minimum of 12 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 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