• Lead Manufacturing Associate

    Astrix Technology (Morrisville, NC)


    Lead Manufacturing Associate

     

    Manufacturing

    Morrisville, NC, US

    Pay Rate Low: 40.00 | Pay Rate High: 42.00

     

    + Added - 22/05/2025

     

    Apply for Job

     

    _Our esteemed client, a leader in therapeutics, renowned for their expertise in creating and manufacturing lifesaving therapies, is in search of an exceptional Associate Manufacturing Engineer to join their dynamic team._

     

    + **Pay:** $40-42/hr.

    + **Terms:** 6 month contract with potential for extension or conversion

    What you will be doing:

    + Use of MBRs and SOPs to produce clinical material from cell expansion through downstream processing in non-GMP and GMP settings.

    + Support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) as well as equipment commissioning and validation, including associated reports and protocols.

    + Assess incoming products against existing Manufacturing Ecosystem and work as part of Tech Transfer to ensure successful scale-up and process implementation.

    + Work with Supply Chain and MSAT to maintain operational readiness for a variety of processing scales by identifying preferred materials for unit operations as well as acceptable substitute items.

    + Update and maintain Standard Operating Procedures (SOPs) and Master Batch Records (MBRs) for process execution and equipment operations in partnership with MSAT and QA.

    + Participate in investigations to determine a root cause for process deviations and author investigation reports.

    + Support troubleshooting for process operations in the event of batch processing issues.

    What you bring to the company:

    + Bachelor of Science Degree (Engineering, Life Sciences, or related technical field) OR Associates/High School Diploma with equivalent industry experience

    + 2+ years experience with AKTA and Unicorn with Downstream Processing in a cGMP environment

    + 1-3 years’ experience in cGMP batch documentation and lifecycle management experience

    + Ability to life, or move 25-50lbs on occasion

    **_This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you**_

    \#LI-DNP

    INDBH

    We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.