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 and cell and gene therapies. 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.
The Development Scientist – Downstream (Associate to Senior-level) will develop robust, cost effective and well-characterized processes for purification of cell culture produced native and novel therapeutic recombinant proteins.
- Develop robust, cost effective and well-characterized, moderately to complex processes for purification of cell culture produced native and novel therapeutic recombinant proteins.
- Scale up and transfer of these processes into a large-scale GMP production environment.
- Design and perform a wide range of viral clearance safety studies.
- Design and execute process validation in support of FDA filings moving towards commercial clinical production.
- Assess and implement new technologies for protein purification and processing.
- Help design and lead the execution of associated work plan(s).
- Represent Downstream Process Development on project teams and in client interactions.
- Direct personnel in experimental work.
- Generate and analyze data, present results to internal teams and clients, and write development reports.
- Contribute to and write process characterization and validation reports.
KNOWLEDGE, SKILLS & ABILITIES:
- Moderate to extensive hands-on experience with proteins, particularly process purification via chromatography and filtration-based methods. Experience with protein characterization and analysis is preferred.
- Experience with product recovery from microbial expression including inclusion body isolation and protein refolding.
- Demonstrated ability to lead projects from straightforward to complex.
- Ability to plan experiments, analyze and interpret results.
- Excellent written and oral communication skills are required. Will document results of development work, write project reports, participate in meetings and give presentations. Ideally can take a lead or plan a support role in client interactions via presentations and discussions.
- Strong inter-personal skills and the ability to lead and work effectively as a productive member of a dynamic team. Must be able to lead and influence the work of others directly or in a matrix organization.
- Additional education and experience may substitute for stated requirements.
- PhD in Biochemical/Chemical Engineering or Biochemistry with 0-5+ years in downstream process development, OR B.S. or M.S. Degree in a related field with significant, hands-on experience in downstream process development setting.
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.