Downstream Manufacturing Associate I/III

AGC Biologics

  • Bothell, WA
  • Permanent
  • Full-time
  • 18 days ago
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.SUMMARY:The role of the Manufacturing Associate is to act as a controller, providing essential duties to support the respective production suite, Supervisor and Manager. On a daily basis, the Manufacturing Associate is expected to have a full understanding of the schedule and required tasks; promoting adequate assessment and response of any production demands. The Manufacturing Support Technician will be responsible for fulfillment of immediate requests from the Manufacturing Operations departments including, but not limited to, assembly preparation, washing parts, autoclaving of parts, kitting parts for delivery and facility sanitizations.PRINCIPAL RESPONSIBILITIES:
  • Responsible for adherence to all Standard Operating Procedures (SOPs), Master Production Records (MPRs), protocols, policies, regulatory requirements, good manufacturing practices (GMPs), and safety guidelines.
  • Participates in and/or leads unit operations described in standard operating procedures, manufacturing batch records, and cGMP guidelines.
  • Proactively works with all team members, subject matter experts, and management to achieve training competency in production operations.
  • Setup, maintenances, and use of cGMP equipment as directed by standard operating procedures and manufacturing batch records.
  • Ensure compliance with company quality systems, safety procedures, and other company policies.
  • Participate and support a culture of continuous improvement. Effectively collaborates with cross functional partners such as Quality Assurance, Quality Control, Supply Chain, and Facilities
  • Reviews executed batch production records to ensure compliance with approved procedures and GMP expectations.
  • Operate analytical equipment, including analytical scale, pH meter, spectrophotometer, filter integrity tester, etc…
  • Mix, store and dispose of chemical solutions (may include hazardous material).
  • Works in a cleanroom environment, performing aseptic processing while maintaining manufacturing environmental conditions.
KNOWLEDGE, SKILLS & ABILITIES:
  • Solid interpersonal and teamwork skills, able to work cross-functionally and collaborate with various levels.
  • Ability to work in a cleanroom environment for extended periods of time.
  • Flexible, have the availability to work hours necessary to support production and / or maintenance activities.
  • Ability to lift up to 50 lbs. with assistance, push, pull, bend, and stand for prolonged periods of time.
  • Willingness to learn and advance within the company and/or department.
EDUCATION/EXPERIENCE:
  • High school diploma or equivalent required.
  • Bachelor’s degree or Biotech certificate, quality systems regulations (cGMP) knowledge and clean room experience preferred but not required.
  • Minimum 1 year of experience working within a federally regulated industry to be considered for a level greater than an Associate I
  • For consideration for a Senior level associate must be proficient with the following systems
  • Viral Segregation (Viral Inactivation/Viral Filtration)
  • AKTA Operations
  • Ultrafiltration and Diafiltration operations.
  • Bulk Filling Operations.
  • A pre-employment lift test and physical may be required for some positions within Manufacturing.
COMPENSATION RANGE:Level I $23.31-$32.05Level II $28.73-$39.50Level III $36.04-$49.55Our 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 and give us a quick Like on !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.

AGC Biologics