ElevateBio - Waltham, MA
posted 2 days ago
About the position
ElevateBio is looking for a Technical Writer that will support aspects of the ongoing Commercial Readiness initiatives at BaseCamp Waltham. The role involves owning and supporting quality and technical documentation for cross-functional teams, generating, revising, reviewing, and approving Standard Operating Procedures (SOPs), policies, and other documents to support commercialization efforts. The Technical Writer will also recommend, support, and drive the implementation of Operational Excellence and Commercial Readiness programs to enhance efficiencies in execution across BaseCamp. Additionally, the role includes supporting the organization and delivery of technical and quality training for teams, as applicable, and ensuring project deliverables are met within critical milestones.
Responsibilities
- Own and support quality and technical documentation for cross-functional teams at BaseCamp
- 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 BaseCamp
- 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
- 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
