Process Development Associate III

AGC Biologics

AGC Biologics

Bothell, WA, USA
Posted on Thursday, September 5, 2024

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

JOB 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 the design of experiments (DoE) and analyzes and interprets experimental results in consultation with the 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 the 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

$83,920.00 - $115,390

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.

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. Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!

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.