Contract \ Contract-to-Hire Technical Writer (Newark, DE)
Job Description
Description:
The technical writer at Biochemist 1 level will be responsible for gathering the necessary information, drafting, editing, coordinating with production area leads, and implementing very complex technical production and testing documentations. The focus of the documentations will be in the areas of protein conjugation and purification, organics, and physical chemistry of solids. These reagents impact all current diagnostics platforms: Dimension, Vista, LOCI, ADVIA, Syva and SCS.
Time frame:
The position is planned for a 12-month period, covering various projects leading to quality improvements and production systems implementation.
Functions and responsibilities include:
– Writing and editing of very complex technical documentation
– Develops, recommends and implements technical documentation process and changes to meet regulatory quality requirements and SAP based manufacturing system needs.
– Medium to large scale manufacture of protein conjugations.
– Protein purification using concentration/diafilteration devices and open column chromatography (size exclusion and Affinity).
– Operate equipment (analytical and production) to complete all manufacturing procedures as prescribed.
– Strong background in protein, organics, and/or polymer analyses.
– Understand the basics of antibody-antigen interactions.
– Knowledge of FDA regulated environment.
– Familiar with GMP, GLP and GDP processes.
– Knowledge or familiarity with SAP production system.
– Background in production processes relative to chemical and physical chemistry.
– Familiar with basic laboratory techniques used in chemistry lab.
– Strong computer skills.
– Strong communication and interpersonal skills.
– Must be able to work independently and be able to multi-task and prioritize daily work.
– Identifies problems as they occur and takes appropriate steps to solve them.
Education:
– The ideal candidate will have an M.S. or B.S. degree with 5-6 years experience in a relevant field with Chemistry/Biochemistry background.