Technical Writer- manufacturing - OQSIE

The client is building internal clinical biologics manufacturing capabilities in Summit, NJ. and we are looking for someone,  with Biologics Manufacturing Experience (4-5 yrs) in early or late-stage processes,  Solid technical skills,  Strong understanding of cGMP operations from Raw material to final DS Bottling.   Ability to work with internal Operations team to help    

This is primarily a  position supporting the Biologics Manufacturing Group in producing technical documents such as Material Specifications, Standard Operating Procedures (SOP’s), Phase appropriate tech Guidance documents and technical reports

Skills:

Minimum Bachelor’s degree with biologics experience

Min 4 - 5 years’ experience in biologics development, clinical or commercial manufacturing

Strong understanding of cGMP operations from raw materials to final drug substance

Experience developing/writing documentation

Support author of material specifications for single-use components and raw materials, and help build a specification database for incoming materials and inventory tracking

Support Author GMP manufacturing operations related to SOPs as assigned

Development Phase appropriate Phase 1 Risk Assessments tied to cGMP Mfg, as required

Maintain compliance with Good Documentation Practices (GDP)