Associate Director Downstream Development - Biologics
- 1808 May 05, 2022 Competitive
The candidate will implement downstream development equipment into the lab to enable downstream process development and characterization.
Qualifications and Skills Required:
- Bachelor's degree in engineering or an applied science is required. An advanced degree is preferred.
- Over seven years of relevant pharmaceutical development and manufacturing experience in Biologics.
- Experience working with downstream technologies at both lab and manufacturing scales.
- Experience scaling up downstream processes and an understanding of the critical elements associated.
- Completed tech transfers, have familiarity with gap analyses and risk assessments.
- Understand IQ, OQ, facility as well as cleaning and process validation.
- Hold a deep understanding of biological processes that includes critical and key process parameters, process and product based impurity generation and removal in support of scale-up and technology transfers.
- Have a working knowledge of process development and/or manufacture of biological products using microbial and/or mammalian expression systems that includes hand-on experience with downstream technologies and understanding of chromatography dynamics and purification principles.
- Demonstrate expertise in technology transfer and/or scale-up/down of processes.
- Have a familiarity with quality systems and both FDA and EU regulations as they relate to process / product development and manufacture of biologics.
- Experience with process characterization activities and Quality by Design (QbD) principles.
- Have a demonstrated track record of delivering timely and consistent results and familiarity with project management skills for technical programs.