Upstream Manufacturing Associate III WA

Our purpose is to bring hope to life by enabling lifechanging 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 Upstream Manufacturing Associate performs basic to advanced bioprocess operations such as (cell culture expansion bioreactor inoculation filtration or recovery) 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 crossfunctionally 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 setup 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 inprocess 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 setup 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 inprocess 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 02 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 24 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 the scientific process.
  

Preferred:

• Experience in stainless steel or singleuse 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 twelvehour shifts.

HOURS

Associates work a 34 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: SuTu (We) 6:0018:30
• B Shift: SuTu (Sa) 18:006:30
• C Shift: ThSa (We) 6:0018:30
• D Shift: WeFr (Sa) 18:006:30

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 sidebyside with our clients and partners every step of the way. We provide worldclass development and manufacture of mammalian and microbialbased 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 cGMPcompliant facilities in Seattle Washington; Boulder and Longmont Colorado; Copenhagen Denmark; Heidelberg Germany; Milan Italy; and Chiba Japan. We currently employ more than 2500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients most complex challenges including specialization in fasttrack projects and rare diseases. AGC Biologics is the partner of choice. To learn more visit.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.