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Pilot Manufacturing Associate Job - Full-time / Part-time
•30 days ago
| Hours | Full-time, Part-time |
|---|---|
| Location | Cambridge, MA Cambridge, Massachusetts |
About this job
Pilot Manufacturing Associate needed for a contract opportunity with Yoh's client located in Cambridge, MA.
The Big Picture - Top Skills Should You Possess:
- Pilot manufacturing
- cGMP
- Cell culture
What You'll Be Doing:
- Work closely with internal collaborators to formulate reagents for development and pilot manufacturing operations process validations.
- Maintain compliance with internal work instructions while performing and documenting various bench work tasks including calculation of molar concentrations for dilutions, batch aliquotation, product labeling.
- Perform pilot manufacturing builds to ensure resupply of internal and external customers with CTA kits consistent with reported needs and timelines
- Manage inventory and ordering of raw materials for pilot manufacturing builds.
- Maintain compliance with 5S processes in all pilot manufacturing areas.
- Assist in the creation and revision of technical documentation including protocols, work instructions, SOPs, batch records.
- Maintain compliance to applicable US and international Medical Device regulations and standards including, but not limited to, 21 CFR 820, ISO 13485, 93 / 42 / EEC, 98 / 79 EC, and the requirements of the CDx Quality Management System.
What You Need to Bring to the Table:
- Bachelor's degree with a minimum of two (2+) years of industry experience in the area of Pilot Manufacturing in a GMP facility
- Experience in reagent formulation and technology transfer to GMP manufacturing, preferably in a diagnostic development setting
- Knowledge and understanding of FDA regulations
Bonus Points! Otherwise Known As Preferred Qualifications:
- Hands-on experience in manufacturing of DNA / RNA controls and / or primers and probes for molecular diagnostic products highly desirable.
- Experience with cell culture a plus.
Opportunity is Calling, Apply Now!
Recruiter: Hannah Cihlar
Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more !
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.
J2W: PROF; CLINICAL
MONJOB
J2WNECLIN
Ref: 1057442
SFSF: LS