AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit: www.agcbio.com.
AGC Biologics is looking for a Director of Downstream Process Development to lead the development of robust, cost-effective, and well-characterized processes for purification of monoclonal antibodies and cell culture derived recombinant proteins. The idea candidate should be in expert in protein biochemistry and bioprocess techniques as it relates to protein purification process development.
- Establish, lead and manage a team of scientists, engineers and technical staff focused on downstream process development activities.
- Establish state-of-the-art scale small-scale downstream models and capabilities.
- Work collaboratively with upstream, analytical, project management, and manufacturing groups to develop an increased depth of knowledge for the drug substance process for a given product and identify improvement opportunities.
- Establish and maintain familiarity with contemporary industrial standards, practices and technology focused on purification process development.
- Communicate downstream process development capabilities to new clients.
- Work collaboratively with existing clients to identify technical solutions and escalate risks appropriately.
- Establish and maintain awareness of current process and product control strategies, critical parameter identification and assessment and in-process control strategies as applied to upstream operations.
- Establish and implement platform approaches for activities and technologies applicable to downstream operations.
- Support change control processes when needed with downscale model data and subject matter expertise.
- Implement QbD principles and design-of-experiment approaches to downstream development activities.
- Support commercialization of molecules with a focus on the transition from late-stage-development to launch as well as post-approval life cycle management.
- Ability to learn and act on dynamic information at a rapid pace.
EDUCATION / EXPERIENCE:
- Ph.D. in chemistry, biochemical/chemical engineering, biochemistry, or other relevant science or engineering field; minimum of 8+ years’ previous experience in downstream process development setting, including hand-on experience with proteins, particularly process purification via chromatography and filtration-based methods.
- Management experience, including a demonstrated ability to effectively manage staff and multiple tasks utilizing organization.
- Experienced in supporting launch and commercial manufacturing.
- Proven track record in building high-performing teams and leadership of department or functional group activities related to a development project.
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.