Pilot Manufacturing Associate 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, a DayCLINICAL

MONJOB J2WNECLIN

Ref:

SFSF: LS