Associate Manufacturing (Pilot Plant) - West Greenwich RI

VetJobs; West Greenwich (RI); On-site; USD 71,000 - 96,000; Full time

Job summary

Amgen is seeking an Associate Manufacturing (Pilot Plant) to support the execution of cell culture, harvest, and purification process studies at the 500L scale at the Rhode Island AR6 Pilot Plant. This on-site, day-shift role involves operating bioreactors, purification skids, and downstream equipment, with responsibilities in process development, tech transfer, and data documentation.

Ideal candidates hold a Bachelor’s or Associate’s in biotech with hands-on GMP/GLP exposure, and experience in

Qualifications

• Minimum Education: High School/GED, Associate’s or Bachelor’s in biotechnology or related field.
• Preferred: experience in bioprocess unit operations and process equipment troubleshooting.

Responsibilities

• Aseptically maintain mammalian cell culture from vial thaw to harvest.
• Operate bioreactors and centrifugation systems for culture and harvest.
• Perform downstream purification steps including chromatography and filtration.
• Conduct in-process sampling and monitoring; maintain ELNs per GLP.
• Participate in tech transfer, OE initiatives, and documentation of experiments.

Skills

Biotech manufacturing

Cell culture

Process development

GxP/GLP

Education

Bachelor’s degree

Associate’s degree + 6 months biotech experience

High school diploma / GED + 2 years biotech experience

Tools

DeltaV

Unicorn Cytiva

Job description

Job Description

ATTENTION MILITARY AFFILIATED JOB SEEKERS - The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

Associate Manufacturing (Pilot Plant)

Let’s do this. Let’s change the world. In this vital role you will support the execution of cell culture, harvest, and purification process studies at the 500L scale, to include operation of single-use bioreactors, centrifugation equipment, chromatography skids and filtration systems. The Amgen Rhode Island AR6 Pilot Plant provides critical technical support for team supply, commercial process development, technology transfer, process characterization, and scale-up/scale-down activities.

This is a day shift position that includes off shift and weekend coverage.

Role Responsibilities

• Aseptically maintain mammalian cell culture through vial thaw, flask passaging, bioreactor operations to harvest, which may include, but not limited to; centrifugation, multistage clarification and/or ATF (Alternating Tangential Flow) filtration
• Protein purification via multi-stage chromatography and filtration systems to include, but not limited to; Ion-Exchange Chromatography (IEX), Affinity Chromatography and Tangential Flow Filtration
• Set-up and operation of bioreactors and vessels, centrifugation and filtration harvest equipment and downstream equipment to include, but not limited to; chromatography and Ultra Filtration Diafiltration (UF/DF) skids
• Perform bench-work studies such as titration and filtration
• Perform in-process sampling and monitoring
• Analyze in-process samples and perform routine analytical equipment maintenance
• Perform batch and filtration of media and buffers
• Perform new product introductions (NPI), technology transfer and participate in equipment or experiment design
• Perform documentation of experimental data in electronic lab notebooks in accordance with Good Laboratory Practices (GLP)
• Perform general lab organization and cleaning
• Management of inventory, operational excellence (OE) initiatives and preventative maintenance for systems and equipment
• Inform-role for operational decision making, troubleshooting and investigative work.

Minimum Education Required

High School/GED

Basic Qualifications

• Bachelor’s degree OR
• Associate’s degree + 6 months of biotechnology in manufacturing, engineering, or process development work experience OR
• High school diploma / GED + 2 years of biotechnology in manufacturing, engineering, or process development work experience

Preferred Qualifications

• An established record of encouraging safety in a lab or manufacturing setting
• Experienced in performing bioprocess unit operations in cell culture and/or purification
• Knowledge in troubleshooting process equipment issues including automation control strategies and utilities such as clean in place (CIP) and clean steam
• Experience in the operation of control systems (Delta V) and method development on Cytiva purification systems using Unicorn
• Experience with data analysis and interpretation
• Experience collaborating with and across functional areas and sites
• Strong written and verbal communication skills; strong computer skills
• Experience in leading Operational Excellence (OE) efforts to drive efficiency and safety

Salary Range

• 70.985,20USD -96.038,80 USD
• >$100,000

City

West Greenwich

State

Rhode Island

Job Category

Management

Job Code

Pharmaceutical Pharmaceutical

Affiliate Sponsor

Amgen