AGC Biologics
Downstream Manufacturing Associate I/II (WA)
AGC Biologics, Bothell, Washington, United States, 98011
locations
Bothell, Washington, USA
time type
Full time
posted on
Posted 30+ Days Ago
time left to apply
End Date: December 20, 2025 (30+ days left to apply)
job requisition id
JR100798
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 The
Downstream Manufacturing Associate
performs basic to advanced bioprocess operations such as (filtration, protein purification,
chromatography/separation,
viral inactivation/UFDF, bulk fill) as well as CIP/SIP operations (cleaning, assembly, sterilization, disassembly, and operation). This role executes daily tasks in accordance with the Master and Finite schedules to meet site objectives, deliverables, and customer commitments. Manufacturing Associates work in either Upstream or Downstream teams and execute batch records, run, and monitor equipment, monitor production processes, and complete documentation in line with cGMP (current good manufacturing practices) and GDP (good documentation procedures). In their daily tasks, Manufacturing Associates always observe and follow safety procedures and Standard Operating Procedures (SOPs). Additionally, Manufacturing Associates work cross-functionally with QA, MSAT, Facilities, and other key departments to ensure ongoing manufacturing operations are successful, reliable, safe, and compliant. An
Associate I
assists with basic bioprocess operations in Manufacturing under supervision in compliance with established processes and standards. An
Associate II
executes basic bioprocess operations independently and supports intermediate to advanced bioprocess operations under guidance. ESSENTIAL JOB
DUTIES/RESPONSIBILITIES
Associate I Assist with basic bioprocess operations in Manufacturing under supervision in compliance with established processes and standards. Safely set-up and operate manufacturing equipment. Prepare, program, monitor, and read outputs of analytical equipment. Read and execute Batch Records using SOPs for operations processes as directed, adhering to cGMP. Identify and escalate process issues. Document, record, and review cGMP data in real time by completing batch records, logbooks, and in-process data. Perform routine cleaning and preventative maintenance of equipment to ensure process readiness. Submit work orders for maintenance and repairs. Attend and actively participate in daily Tier 0 shift change meetings. Maintain a clean and safe work environment to ensure audit readiness at all times, practicing LEAN principles. Report safety observations in a timely manner. Complete assigned trainings and qualifications as required. Support projects, initiatives, and team goals by delivering on all assigned tasks. Execute additional manufacturing activities and process support with other manufacturing groups and cross functional partners to support continuous improvement of the value stream. ESSENTIAL JOB
DUTIES/RESPONSIBILITIES
Associate II Execute basic bioprocess operations independently and support intermediate to advanced bioprocess operations under guidance. Safely set-up and operate manufacturing equipment. Prepare, program, monitor, and read outputs of analytical equipment. Read and execute Batch Records using SOPs for operations processes as directed, adhering to cGMP. Analyze issues and recommend solutions based on standardized processes and procedures with guidance. Escalate as needed. Document, record, and review cGMP data in real time by completing batch records, logbooks, and in-process data. Support investigations by responding to inquiries in a timely manner. May initiate Deviations under supervision. Perform routine cleaning and preventative maintenance of equipment to ensure process readiness. Submit work orders for maintenance and repairs. Attend and actively participate in daily Tier 0 shift change meetings. Maintain a clean and safe work environment to ensure audit readiness at all times; practicing LEAN principles. Report safety observations in a timely manner. Complete assigned trainings and qualifications as required and seek opportunities for continual learning. Assist with onboarding less experienced team members on basic procedures. Support projects, initiatives, and team goals by delivering on all assigned tasks. Execute additional manufacturing activities and process support with other manufacturing groups and cross functional partners to support continuous improvement of the value stream. Participate in projects and process improvements to reduce risk and increase efficiency. LEADERSHIP SKILLS You integrate development into your daily tasks. You prioritize and take action on your personal development. You act as a team player, promoting and living Core Values. You cooperate across the organization. You are aware of the impact of your tasks. You excel in your area of expertise. You contribute to the ongoing development of your area of expertise. You perform your tasks with the customer in mind. You take action in due time to secure business results, maintaining high standards of quality. QUALIFICATIONS Required: Associate I
-
BS/BA or related technical degree and 0-2 years of relevant experience. Equivalent education and experience may substitute for stated requirements. Basic understanding of scientific process. Strong focus on quality and attention to detail. Adaptable to changing needs and demands, comfortable navigating a dynamic environment. Strong communication skills and ability to work as a part of a team. Associate II
-
BS/BA or related technical degree and 2-4 years of relevant experience. Equivalent education and experience may substitute for stated requirements. Stated required qualifications for the Associate I and a demonstrated understanding of scientific process. Preferred: Experience in stainless steel or single-use platform technology. Strong mechanical aptitude. Physical Requirements: Must be able to perform aseptic gowning and work in a clean room environment. Must be able to lift/carry up to 40 pounds and complete required paperwork. Must be able to sit and stand for extended periods. Must be available to work twelve-hour shifts. HOURS Associates work a 3-4 schedule (three 12hr shifts week one and four 12hr shifts week two). Our Manufacturing team has four shifts. Night shifts are eligible for shift differential. A Shift: Su-Tu (We) 6:00-18:30 B Shift: Su-Tu (Sa) 18:00-6:30 C Shift: Th-Sa (We) 6:00-18:30 D Shift: We-Fr (Sa) 18:00-6:30 COMPENSATION RANGE Associate I - $23.31 - $32.04 Associate II - $28.73-$39.50 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.
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! 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. 0:00
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Bothell, Washington, USA
time type
Full time
posted on
Posted 30+ Days Ago
time left to apply
End Date: December 20, 2025 (30+ days left to apply)
job requisition id
JR100798
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 The
Downstream Manufacturing Associate
performs basic to advanced bioprocess operations such as (filtration, protein purification,
chromatography/separation,
viral inactivation/UFDF, bulk fill) as well as CIP/SIP operations (cleaning, assembly, sterilization, disassembly, and operation). This role executes daily tasks in accordance with the Master and Finite schedules to meet site objectives, deliverables, and customer commitments. Manufacturing Associates work in either Upstream or Downstream teams and execute batch records, run, and monitor equipment, monitor production processes, and complete documentation in line with cGMP (current good manufacturing practices) and GDP (good documentation procedures). In their daily tasks, Manufacturing Associates always observe and follow safety procedures and Standard Operating Procedures (SOPs). Additionally, Manufacturing Associates work cross-functionally with QA, MSAT, Facilities, and other key departments to ensure ongoing manufacturing operations are successful, reliable, safe, and compliant. An
Associate I
assists with basic bioprocess operations in Manufacturing under supervision in compliance with established processes and standards. An
Associate II
executes basic bioprocess operations independently and supports intermediate to advanced bioprocess operations under guidance. ESSENTIAL JOB
DUTIES/RESPONSIBILITIES
Associate I Assist with basic bioprocess operations in Manufacturing under supervision in compliance with established processes and standards. Safely set-up and operate manufacturing equipment. Prepare, program, monitor, and read outputs of analytical equipment. Read and execute Batch Records using SOPs for operations processes as directed, adhering to cGMP. Identify and escalate process issues. Document, record, and review cGMP data in real time by completing batch records, logbooks, and in-process data. Perform routine cleaning and preventative maintenance of equipment to ensure process readiness. Submit work orders for maintenance and repairs. Attend and actively participate in daily Tier 0 shift change meetings. Maintain a clean and safe work environment to ensure audit readiness at all times, practicing LEAN principles. Report safety observations in a timely manner. Complete assigned trainings and qualifications as required. Support projects, initiatives, and team goals by delivering on all assigned tasks. Execute additional manufacturing activities and process support with other manufacturing groups and cross functional partners to support continuous improvement of the value stream. ESSENTIAL JOB
DUTIES/RESPONSIBILITIES
Associate II Execute basic bioprocess operations independently and support intermediate to advanced bioprocess operations under guidance. Safely set-up and operate manufacturing equipment. Prepare, program, monitor, and read outputs of analytical equipment. Read and execute Batch Records using SOPs for operations processes as directed, adhering to cGMP. Analyze issues and recommend solutions based on standardized processes and procedures with guidance. Escalate as needed. Document, record, and review cGMP data in real time by completing batch records, logbooks, and in-process data. Support investigations by responding to inquiries in a timely manner. May initiate Deviations under supervision. Perform routine cleaning and preventative maintenance of equipment to ensure process readiness. Submit work orders for maintenance and repairs. Attend and actively participate in daily Tier 0 shift change meetings. Maintain a clean and safe work environment to ensure audit readiness at all times; practicing LEAN principles. Report safety observations in a timely manner. Complete assigned trainings and qualifications as required and seek opportunities for continual learning. Assist with onboarding less experienced team members on basic procedures. Support projects, initiatives, and team goals by delivering on all assigned tasks. Execute additional manufacturing activities and process support with other manufacturing groups and cross functional partners to support continuous improvement of the value stream. Participate in projects and process improvements to reduce risk and increase efficiency. LEADERSHIP SKILLS You integrate development into your daily tasks. You prioritize and take action on your personal development. You act as a team player, promoting and living Core Values. You cooperate across the organization. You are aware of the impact of your tasks. You excel in your area of expertise. You contribute to the ongoing development of your area of expertise. You perform your tasks with the customer in mind. You take action in due time to secure business results, maintaining high standards of quality. QUALIFICATIONS Required: Associate I
-
BS/BA or related technical degree and 0-2 years of relevant experience. Equivalent education and experience may substitute for stated requirements. Basic understanding of scientific process. Strong focus on quality and attention to detail. Adaptable to changing needs and demands, comfortable navigating a dynamic environment. Strong communication skills and ability to work as a part of a team. Associate II
-
BS/BA or related technical degree and 2-4 years of relevant experience. Equivalent education and experience may substitute for stated requirements. Stated required qualifications for the Associate I and a demonstrated understanding of scientific process. Preferred: Experience in stainless steel or single-use platform technology. Strong mechanical aptitude. Physical Requirements: Must be able to perform aseptic gowning and work in a clean room environment. Must be able to lift/carry up to 40 pounds and complete required paperwork. Must be able to sit and stand for extended periods. Must be available to work twelve-hour shifts. HOURS Associates work a 3-4 schedule (three 12hr shifts week one and four 12hr shifts week two). Our Manufacturing team has four shifts. Night shifts are eligible for shift differential. A Shift: Su-Tu (We) 6:00-18:30 B Shift: Su-Tu (Sa) 18:00-6:30 C Shift: Th-Sa (We) 6:00-18:30 D Shift: We-Fr (Sa) 18:00-6:30 COMPENSATION RANGE Associate I - $23.31 - $32.04 Associate II - $28.73-$39.50 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.
W
ant 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. 0:00
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