The Position

This position will primarily work closely with scientists to write and develop GMP batch records and other documents for the synthesis of oligonucleotides, as well as review of executed batch records. The position will also assist with writing and updating SOPs and technical documents pertaining to GMP operations. 

Responsibilities

• Work with the scientists to write/develop GMP batch records for use with oligonucleotide manufacturing 
• Draft/manage protocols, SOPs, specification documents, and other Quality System Documents 
• Maintain templates of documents to reflect current best practices 
• Perform reviews of executed batch records 
• Work with different departments to achieve project readiness goals 
• Occasionally assist with laboratory work as needed 

Requirements:

• BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry 

• Minimum of 1 to 5 years with either technical scientific writing experience or experience in a laboratory setting 
• Experience working in a GMP setting 
• Experience with controlled documentation 
• Good verbal and written communication skills 
• Excellent technical writing skills with high attention to detail 
• Proficiency in Microsoft Word and Excel 
• Ability to work across teams