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.
Job Description: Development Associate II - IV / Downstream Process Development
SUMMARY:
You will be part of a process development team responsible for:
- Development of robust, cost effective and well-characterized processes for purification of monoclonal antibodies and recombinant proteins.
- Bench scale production to demonstrate process performance.
- Design and performance of viral clearance studies.
- Support of process transfer and scale-up into the cGMP manufacturing facility.
- Process validation planning and execution if required for commercial capabilities.
- Assessment and implementation of new technologies for protein purification and processing.
KNOWLEDGE, SKILLS & ABILITIES:
Key Responsibilities
- Execution of work plans in a hands-on laboratory setting.
- Able to recognize technical problems and troubleshoot process parameters.
- Analyze and assemble data, presentations and reports.
- Provide technical support to manufacturing in support of large scale manufacturing campaigns
- May represent process development on project teams and in client interactions, presents data at client meetings (onsite or teleconferences) as necessary.
Requirements:
- Ability to plan experiments, analyze and interpret results and move to the next step with periodic supervision. Experience with statistical analysis and experimental design, 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 potentially participate in meetings and give presentations.
- Good inter-personal skills and a desire to work as part of a team.
EDUCATION/EXPERIENCE:
- B.S./M.S. in biochemistry/chemistry or biochemical/chemical engineering or related discipline.
- 2 - 8 years in a process development setting (0 - 5 years for Masters degree with thesis). 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.
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. EOE
COMPENSATION RANGE
$69,750 - $129,250 annually based on title and experience.
Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities.
Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave.
Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company’s performance and the Team Member’s performance.
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.