Lead Manufacturing Associate Position Available In Wake, North Carolina
Tallo's Job Summary: The Lead Manufacturing Associate position in Morrisville, NC offers a pay rate of $40-42/hr. The role involves producing clinical material, supporting testing and validation processes, and ensuring successful scale-up and implementation. Requirements include a Bachelor's Degree in a related field or equivalent experience, 1-3 years' experience in cGMP batch documentation, and the ability to lift or move 25-50lbs occasionally. The position is with a renowned therapeutics company with potential for extension or conversion.
Job Description
Lead Manufacturing Associate
Manufacturing
Morrisville, NC, US
Pay Rate Low:
40.00 |
Pay Rate High:
42.00 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
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
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