AGC Biologics
Downstream Manufacturing Associate III/Senior (WA)
AGC Biologics, Bothell, Washington, United States, 98011
Downstream Manufacturing Associate
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. Essential Job Duties/Responsibilities
Associate III
Execute basic to intermediate bioprocess operations independently as a Qualified Verifier and support advanced bioprocessing 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 make decisions within defined parameters to resolve a wide range of issues in creative ways. Escalate as needed. Document, record, and review cGMP data in real time and guide other operators in properly completing batch records, logbooks, and in-process data. Assist with creation, review and revision of GMP documentation (SOPs, Batch Records, Work Instructions etc.). Support investigations by responding to inquiries in a timely manner. Initiates Deviations. May own minor investigations. 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. Train less experienced team members on basic to intermediate processes and procedures. Qualified Trainer on basic to intermediate operations. 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. Recommend and execute projects and process improvements to reduce risk and increase efficiency. Contributes to a culture of teamwork, compliance and positive behaviors and attitudes. Essential Job Duties/Responsibilities
Associate Sr.
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. Independently analyze issues, troubleshoot, and solve highly complex problems providing and executing innovative solutions. Escalate as needed. Document, record, and review cGMP data in real time and guide other operators in properly completing batch records, logbooks, and in-process data. Assist with creation, review, and revision of GMP documentation (SOPs, Batch Records, Work Instructions etc.). May initiate CAPAs or Change Controls if trained. Support investigations by responding to inquiries in a timely manner. Initiates Deviations. May own minor investigations. 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. Train less experienced team members on basic to advanced processes and procedures. Qualified Trainer for all operations. 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. Helps manage and implement continuous improvement projects. Responsible for influencing teamwork, compliance and positive behaviors and attitudes. Assist Supervisor with team workflow to ensure adherence to overall schedule. Leads team operations in Supervisor absence. 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 III
- BS/BA or related technical degree and 4-6 years of relevant experience. Equivalent education and experience may substitute for stated requirements. Strong 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 Sr.
- BS/BA or related technical degree and 6-8 years of relevant experience. Equivalent education and experience may substitute for stated requirements. Stated required qualifications for the Associate III and experience in training operators on manufacturing processes. 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 III - $36.03-$49.55 Associate Sr. - $40.34-$55.47 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
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. Essential Job Duties/Responsibilities
Associate III
Execute basic to intermediate bioprocess operations independently as a Qualified Verifier and support advanced bioprocessing 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 make decisions within defined parameters to resolve a wide range of issues in creative ways. Escalate as needed. Document, record, and review cGMP data in real time and guide other operators in properly completing batch records, logbooks, and in-process data. Assist with creation, review and revision of GMP documentation (SOPs, Batch Records, Work Instructions etc.). Support investigations by responding to inquiries in a timely manner. Initiates Deviations. May own minor investigations. 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. Train less experienced team members on basic to intermediate processes and procedures. Qualified Trainer on basic to intermediate operations. 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. Recommend and execute projects and process improvements to reduce risk and increase efficiency. Contributes to a culture of teamwork, compliance and positive behaviors and attitudes. Essential Job Duties/Responsibilities
Associate Sr.
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. Independently analyze issues, troubleshoot, and solve highly complex problems providing and executing innovative solutions. Escalate as needed. Document, record, and review cGMP data in real time and guide other operators in properly completing batch records, logbooks, and in-process data. Assist with creation, review, and revision of GMP documentation (SOPs, Batch Records, Work Instructions etc.). May initiate CAPAs or Change Controls if trained. Support investigations by responding to inquiries in a timely manner. Initiates Deviations. May own minor investigations. 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. Train less experienced team members on basic to advanced processes and procedures. Qualified Trainer for all operations. 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. Helps manage and implement continuous improvement projects. Responsible for influencing teamwork, compliance and positive behaviors and attitudes. Assist Supervisor with team workflow to ensure adherence to overall schedule. Leads team operations in Supervisor absence. 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 III
- BS/BA or related technical degree and 4-6 years of relevant experience. Equivalent education and experience may substitute for stated requirements. Strong 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 Sr.
- BS/BA or related technical degree and 6-8 years of relevant experience. Equivalent education and experience may substitute for stated requirements. Stated required qualifications for the Associate III and experience in training operators on manufacturing processes. 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 III - $36.03-$49.55 Associate Sr. - $40.34-$55.47 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