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.
We have an opportunity for a Development Associate III to join the Downstream Process Development group. The primary responsibility of this position will be to support development and characterization of purification processes for therapeutic proteins. The successful candidate will be responsible for execution of preparative to pilot scale purification steps and collection of process performance data. In additional to experimental work, a successful candidate with be responsible for writing process development reports. Strong written and verbal communication skills are a must. Project work will specifically require expertise in a risk-based Design of Experiments (DOE) approach to process characterization in order to support both development and commercialization of products.
Design and execution of work plans, i.e. this is primarily a hands-on laboratory position.
Analyze and assemble data, presentations and reports.
Represent process development on project teams and in client interactions, as necessary.
Provide technical support to manufacturing in support of large scale manufacturing campaigns
KNOWLEDGE, SKILLS & ABILITIES:
Hands-on experience with proteins, particularly process purification via chromatography and filtration-based methods. Hands-on experience with protein characterization and analysis is also a plus. Knowledge of using equipment such as AKTA chromatography purification systems, automated TFF systems, and normal flow filtration techniques including viral filtration.
Have understanding of scale up and scale down principles for DSP unit operations.
Possesses thorough understanding of protein biochemistry, bioprocess techniques as it relates to protein purification process development.
Knowledge of appropriate analytical assays for characterization of product quality attributes for therapeutic proteins.
Ability to plan experiments, analyze and interpret results and move to the next step. Experience with Design of Experiments (DOE) and statistical analysis, i.e. JMP, is an advantage.
Careful attention to detail in record keeping, data analysis and reporting and maintenance of a clean and orderly work area.
Excellent written and oral communication skills are required as this individual will document results of development work on a daily basis, write project reports, and occasionally participate in meetings with cross-functional teams to give technical presentations.
Good inter-personal skills and a desire to work as part of a team.
B.S./M.S. in biochemistry/chemistry or biochemical/chemical engineering or related discipline.
Experience with preparative scale chromatography including, affinity, IEX, HIC.
3+ years in a process development setting. Hands-on experience with purification process characterization is also a plus.
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. EOE
CMC Icos Biologics Inc.