|at ( view profile)|
|Date Posted||April 15, 2020|
|Address||726 Heartland Trail|
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
The Senior Manager, Manufacturing Sciences and Technology position will support and lead a group in technical support of the manufacturing group, including the transfer between external clients or Process Development and Manufacturing.
The Senior Manager, Manufacturing Sciences and Technology position will lead a group of engineers 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-the-floor technical support to manufacturing. The manager will be responsible for the drafting and review of documentation, compilation of process data, and provide technical input in the deviation investigation, change controls, and CAPAs. The manager will be client facing and work collaboratively with clients to move projects forward.
In concert with Catalent’s Patient First philosophy, this role is critical to the safe and on-time delivery of our clients’ products to patients by providing guidance and oversight of well-defined and documented manufacturing processes.
- 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, and facilities departments to effectively transfer and maintain processes in the facility.
- Participates in and Supports strategic alignment across Catalent Biologics sites and within the Madison site.
- Works closely with manufacturing to provide on-the-floor technical oversight before and during GMP runs.
- Leads the compilation of process data, including communicating project status, and delivering internal and client presentations.
- Evaluates existing processes and identifies process and/or equipment improvement to improve efficiency, consistency, and competitiveness within the market.
- Supports the building of business case for process improvement projects
- Reviews technical documents including batch production records, specifications, project reports, and engineering specifications.
- 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 and/or Downstream processes at the small to intermediate scale of cGMP biologics production
- Prior experience in process scaling and technology transfer
- Experience in report and documentation skills
- Experience in investigating and closing out deviations, OOS, and CAPAs
- Experience writing and revising standard operating procedures and batch production records
- Experience with operating and troubleshooting process equipment
- Experience working on late phase and commercial programs is a plus
Catalent’s standard leadership competencies that are used to interview and for Performance & Development
- Leads with Integrity and Respect
- Delivers Results
- Demonstrates Business Acumen
- Fosters Collaboration and Teamwork
- Champions Change
- Engages and Inspires
- Coaches and Develops
- 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 (PTO) + 7 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