Downstream Process Development Associate III

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

This is an exciting position in our Downstream Process Development team.  Primary responsibilities include developing and optimization of therapeutical protein purification processes for GMP manufacturing.  This role may also include technology development and collaboration with clients.

ESSENTIAL JOB DUTIES/RESPONSIBILITIES

• Development of robust, cost effective and well-characterized processes for purification of monoclonal antibodies and recombinant proteins. 

• Bench scale production to demonstrate process performance.
• 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.

• Contributes to design of experiments (DoE) and analyzes and interprets experimental results in consultation with supervisor as needed.
• Write protocols, client reports, and templates with limited supervision.
• Enables downstream process transfer from Process Development labs to Manufacturing.
• Contribute to or conduct continuous lab improvement and management.
• Acts as a resource for less experienced team members and colleagues.

 Requirements:

• 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.
• 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 interpersonal skills and a desire to work as part of a team and across teams. 

 QUALIFICATIONS

• B.S./M.S. degree and 3-5+ years of relevant experience. Equivalent education and experience may substitute for stated requirements.
• Proficiency in protein purification and relevant lab methodologies.

Preferred:

• Previous experience with process development and knowledge of large-scale manufacturing activities.

COMPENSATION RANGE:

$83,920.00 - $115,390.00

 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.