About The Role:
The Senior Associate Scientific Writer independently leads documentation projects across operational, analytical, microbiological, and stability functions within QC. This role requires deeper collaboration with subject matter experts across all departments and QC team members of all levels.
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
Qualifications:
- 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 Skills:
- 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
Work Environment and Physical Demands
This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area.
Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.