Senior Associate Scientist, Scientific Writing

Job description

**Forge Your Future with Us:** At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from idea into reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities — all united by one goal: improving lives. If you’re driven by purpose and excited to make a tangible impact, this is where your journey begins. Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio. Here, you won’t just watch innovation happen — you’ll be part of it. Whether you’re scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, you’ll play a key role in bringing hope to patients with genetic diseases. What sets Forge apart is our culture of **H.O.P.E.** We are **hardworking**, showing up each day with determination and grit. We are **open**, creating a space where ideas flow freely and every voice is valued. We are **purpose-driven**, with every task directly tied to changing lives. And we are **engaged**, energized by the challenges we face and the milestones we achieve together. At Forge, your growth matters. We’re committed to helping you expand your skills, take on new challenges, and develop your career through mentorship, hands-on learning, and opportunities for advancement. Our people are our greatest investment, and we’re proud to see team members grow with us. If you’re ready to use your talent to help deliver hope to patients around the world, join us — and be part of something bigger than yourself. **About The Role:** The Senior Associate Scientist, Scientific Writing 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 **We’ve Got You Covered:** At Forge Biologics, we believe our people deserve to be taken care of — in and out of the workplace. We’ve built a comprehensive compensation and benefits package designed to help you thrive, grow, and feel valued every step of the way: **Health from day one** - Health, dental, and vision insurance start your first day — with 90% of premiums covered for you *and* your family. **Time to recharge** - A competitive paid time off plan — because rest fuels innovation. - 12 weeks of fully paid parental leave so you can focus on family when it matters most. **Rewarding your impact** - Annual bonus opportunities for all full-time team members. - 401(k) with company match to help you plan for the future. - Special employee discounts, including childcare and dependent care savings. **Your wellness, supported** - Onsite fitness facility at The Hearth - Mental health counseling and financial planning services through our Employee Assistance Program. - Employer-paid short- and long-term disability coverage to protect your peace of mind. **Fuel for your workday** - A fully stocked kitchen with free snacks and beverages — we keep you energized and ready for what’s next. **Grow with us** - Ongoing professional development resources, training opportunities, and mentorship programs to help you build your career and grow within Forge.