Downstream Process Development Scientist I/II

About AGC Biologics  
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.

SUMMARY:

The Development Scientist – Downstream will develop robust, cost effective and well-characterized processes for purification of cell culture produced native and novel therapeutic recombinant proteins and 

PRINCIPAL RESPONSIBILITIES:

• Develop robust, cost-effective, and well-characterized moderate to complex purification processes for cell-culture produced native and novel therapeutic recombinant proteins and monoclonal/bi-specific antibodies.
• Scale-up and transfer these processes into a large-scale GMP production environment.
• Designs and performs technically challenging experiments. Direct personnel in experimental work.
• Works with clients and internal project teams to successfully complete projects. 
• 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.
• Represent Downstream Process Development on project teams and in client interactions, and coordinate activities with other internal departments (Project Management, Upstream Process Development, Analytical and Formulation Development, and Manufacturing).
• Generate and analyze data, present results to internal teams and clients, and write development reports.
• Contribute to and author process development, process characterization and validation reports.

KNOWLEDGE, SKILLS & ABILITIES:

• Extensive hands-on experience with proteins, particularly process purification via a variety of chromatography and filtration-based methods. Experience with protein characterization and analysis is preferred.
• Demonstrated ability to lead projects from straightforward to complex.
• Ability to plan experiments, analyze and interpret results. Experience with statistical DOE models is preferred.
• Excellent written and oral communication skills are required to document results of development work, write project reports, participate in meetings and give presentations. Ability to take a lead 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.
• Contributes to professional development of others; may mentor development associates on job duties and general departmental operations.

EDUCATION/EXPERIENCE:

• PhD in Biochemical Engineering, Biology, Biochemistry or related field with 1-2+ years of experience, or BS/MS degree in a related field with 5-10+ years of experience. Equivalent education and experience may substitute for stated requirements. 

COMPENSATION RANGE:

$94,000 - $148,610 annually

Deadline

The deadline for applications is the 31st of March

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.