Forge Biologics · 6 hours ago
Senior Associate Scientist, Scientific Writing
Forge Biologics is a company focused on biotechnological advancements, and they are seeking a Senior Associate Scientist specializing in Scientific Writing. This role involves leading documentation projects, collaborating with cross-functional teams, and ensuring high-quality technical documents aligned with QC requirements.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Works with cross-functional teams with guidance from direct supervisor and senior team members to develop and maintain high-level technical and scientific documents, including Standard operating procedures for the QC group, Protocols and reports using established templates
Owns and manages documentation projects by participating in cross-departmental conversations to ensure alignment with QC requirements
Assists SMEs and development teams through updates driven by method qualification, continuous improvement, or change controls
Assists junior QC associates in writing standards
Reviews documentation for quality, and ensures alignment across client deliverables
Collaborates with SMEs to identify gaps in documentation and fill those gaps with clear, accurate information
Organize information from multiple sources impacting documentation
Demonstrates fluency in Veeva Vault and communicates with system owners to ensure process continuity
Qualification
Required
Bachelor's degree in a science field with 2-3 years of experience, or Master's in a science field with writing experience
Demonstrated leadership, strategic thinking
Proven ability to manage ambiguity, lead complex projects, and influence cross-functional teams
Experience authoring complex technical documents
Knowledge of complex molecular biology, biochemistry, or cell biology techniques and analytical methods (e.g., qPCR, cell-based infectivity assays, potency assays)
Experience in scientific communication
Skilled in managing multiple document types and priorities simultaneously
Excellent written, verbal, and project coordination skills
High proficiency in documentation systems, formatting tools, and visualization software
Preferred
Previous exposure regulatory guidelines (ICH, FDA, EMA)
Experience mentoring or training junior teammates
Proficiency with Smartsheet, Veeva Vault, SmartDraw, Visio, Adobe Acrobat, or similar tools
Expertise in software tools such as Veeva Vault, SmartDraw, Visio, and Adobe Acrobat
Strategic thinking with a continuous improvement mindset related to document systems and compliance
Company
Forge Biologics
Forge Biologics is a gene therapy development engine, enabling access to life changing gene therapy programs.
H1B Sponsorship
Forge Biologics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (4)
2023 (2)
2022 (1)
Funding
Current Stage
Growth StageTotal Funding
$330MKey Investors
State of OhioMidCap FinancialRA Capital Management
2023-11-13Acquired
2022-09-12Series C· $90M
2022-01-10Grant
Leadership Team
Recent News
2025-12-24
Coherent Market Insights Pvt. Ltd
2025-12-03
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