Technical Writer, Commercial Readiness (Contract)

We are looking for a Technical Writer that will support aspects of the on-going Commercial Readiness initiatives at our clients facility in Waltham.

Functions:

• Own and support quality and technical documentation for cross-functional teams at the Waltham facility
• Generate, revise, review and approve Standard Operating Procedures (SOPs), policies, and other documents to support commercialization efforts
• Recommend, support, and drive implementation of Operational Excellence and Commercial Readiness programs supporting efficiencies in execution and across our client’s facility in Waltham
• Support organization and delivery of technical and quality training teams, as applicable
• Support project team environment with project deliverables, ensuring critical milestones are successfully achieved

Requirements

Requirements:

• Minimum Bachelor’s Degree in Engineering, Biology, Chemistry, or a related field
• At least 4 years of experience in a Manufacturing, Quality, or Regulatory role supporting both early phase and commercial cell therapy products.
• Experience working within a contract manufacturing or client service organization.
• Familiarity with manufacturing/quality architectures and systems (e.g. SAP, electronic batch records, Veeva)
• Demonstrated ability and strength in leading or supporting cross-functional teams
• Strong attention to detail supported by excellent time management and organizational skills