|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 Director, Downstream Process Development will lead a group of scientists to achieve robust and a scalable purification processes to support early and late phase programs. The position will support the development of purification processes for a wide variety of molecules and modalities.
The Director, Downstream Process Development will manage and support partner interactions including teleconferences, presentations, and face to face visits. This role will interface with other development functions as well as operations, quality, supply chain, and facilities groups.
In concert with Catalent’s Patient First philosophy, this role will play a key role in developing and leading robust and scalable protein purification processes to deliver pre-clinical material for client studies. These processes will then be transferred our cGMP manufacturing group and this position will support the team to ensure the successful production of pharmaceutical drugs for life saving clinical studies.
***Please note that relocation assistance is available for the right candidate***
- Direct a group of scientists in the development of robust and scalable downstream processes for monoclonal antibodies, bispecific antibodies, Fc-, Fab-, and HSA-fusion proteins, and other recombinant proteins to support GMP manufacture for Phase I/II clinical trials.
- Manage process development and pilot scale projects including regular updates to partners, data management, investigations, technical report writing
- Manage viral clearance studies to support Phase I/II/III clinical studies including establishing of scale down models
- Support technology transfer method for early phase programs including external and internal transfers
- Draft and review batch production records for engineering and GMP batches
- Lead and support event and deviation investigations for GMP production
- PhD in Biotechnology, or related field, with minimum of 8 years of relevant experience; or
- M.S./M.A. in Biotechnology, or related field, with minimum of 12 years of relevant experience; or
- B.S./B.A. in Biotechnology, or related field, with minimum of 14 years of relevant experience.
- Experience with downstream processes at the small to intermediate scale of cGMP biologics production including chromatography and filtration.
- Prior experience in process scaling and technology transfer
- Experience in report and documentation skills
- Experience in designing viral clearance studies
- 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\