Contract Documentation Specialist II

This is an onsite position.

Duties

Scientific writer will work closely with Purification group leaders and Subject Matter Experts in drafting, formatting and completion technical documents required for the development and characterization of biological molecules, from clinical studies to commercial products.

Responsibilities, Under The Supervision Of a Principal Scientist

• Initiating, drafting, and preparing the first draft of assigned documents (Process development Reports, Process characterization/Validation study Protocols and reports, Risk Assessments report, Drafting/updation of SOPs.
• Closely working with matrix environment of Purification development and CMC Project management to teams to document process risk, characterization, control, and validation matrix.
• Provide editorial support, ensuring quality of all scientific content, with a focus on clarity, accuracy, and consistency while adhering to proper formatting and regulatory requirements
• Initiate and oversee multiple rounds of document review and subsequent revisions by proactively interacting purifications SMEs.
• Perform data integrity review, process documentation gap analyses and update platform documents for report requirements.
• Contribute to overall success of the organization by ensuring timely completion of documents required project progression, and other regulatory supporting documents.
  
  

Skills

A Bachelors, Masters or PhD degree in chemical or biochemical engineering, biochemistry or biology with typically 3-5+ years of work experience with knowledge of protein purification and standard analytical techniques is required