Senior Technical Writer

About Forge

Our mission at Forge Biologics, is to enable access to life changing gene therapies and help bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping to champion teams that are navigating the long road from the lab bench to the bedside. Our goal is simple but vital to patients living with disease, and we take it seriously. With a patient-first approach, we are forging new models for working together to better accelerate these transformative medicines to reach those who need them the most.

Forge is based in Columbus, Ohio, in a 200,000 square foot facility known affectionately by team members as, the Hearth. The Hearth, is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services.

About The Role

We are currently seeking an experienced Senior Technical Writer to join the Forge Biologics team. This is an exciting opportunity to drive the startup efforts by authoring, reviewing and processing documents needed for our Columbus, Ohio operations. The candidate will collaborate with site Subject Matter Experts (SMEs) in order to transcribe process, procedure and work instructions into usable documents that will support our Quality Management System and adhere to cGMP principles.

The Senior Technical Writer is responsible for authoring documents in support of all current departments at the Columbus facility. These areas include Safety, Quality, Training, Regulatory, Maintenance, Development, Operations, and Validation efforts. This role will also support all new documents that may be deemed necessary as business requires.

What You'll Do

• Writes, edits, and reviews manufacturing documents, validation protocols, SOPs, and development related material, while maintaining standardized and consistent documentation practices for recording details of new processes for the manufacture of biopharmaceutical products
• Organizes material according to set standards regarding order, clarity, conciseness, style, and terminology
• Edits, standardizes, or suggests changes to material prepared by other writers or Forge personnel to verify accuracy, consistency, grammar, and format
• Maintains records and files of work and revisions
• Collaborates with Development and Operations personnel to become familiar with product technologies and production methods
• Observes production, developmental, and experimental activities to determine operating procedure and detail
• Selects photographs, drawings, sketches, diagrams, and charts to illustrate material
• Studies drawings, specifications, mockups, and product samples to integrate and delineate technology, operating procedure, and production sequence and detail
• Reviews manufacturer's manuals and trade catalogs, drawings and other data relative to operation, maintenance, and service of equipment
• Confers with customer representatives, vendors, facility executives, or publishers to establish technical specifications and to determine subject material to be developed

What You'll Bring

• Bachelor's Degree (B.A. or B.S.) in Biology, Biochemistry, Biomedical Engineering or related life science field (or equivalent experience).
• Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems.
• Excellent organizational skills and the ability to multitask in a fast-paced environment while adhering to strict timelines.
• Good interpersonal and communication skills, both written and verbal, to effectively collaborate with team members and stakeholders.
• Commitment to following SOPs, safety protocols, and regulatory guidelines to ensure compliance and product quality.
• Ability to adapt to changing priorities and work independently as well as part of a team.
• Flexibility to work in shifts, including weekends and holidays, as required by manufacturing schedules.

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.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned.

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.

Life at Forge

We are a team of diverse, driven and passionate people working together to trailblaze a new model for how we make medicines to treat patients with genetic diseases. Our team members use their creativity and talent to invent new solutions, meet new demands, and offer the most effective services in the industry. Forge's core values lay the foundation for H.O.P.E. It provides us a common purpose that we all understand, work towards and live by. 

HARDWORKING - We work hard and smart, making a persistent and determined effort toward success. Working hard, with focus and desire is the key.

OPEN - We strive to be approachable, actively listen and encourage others to contribute and speak up. We positively offer and receive constructive feedback.

PURPOSE DRIVEN - We are passionate about working towards and delivering on our mission to manufacture gene therapies.

ENGAGED - We are fully absorbed by and enthusiastic about our work and take positive action to further Forge's vision, mission and goals.

We've Got You Covered

We take the health and happiness of our employees seriously and are consistently evaluating new ways to make our benefits truly UnFORGEttable.

• Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependents
• Flexible PTO (plus 14 paid company holidays)
• Annual bonus for all full-time employees
• 401(K) company match
• Fully-stocked kitchen with free food/drinks
• 12 weeks of paid parental leave - additional discount programs include childcare support & dependent care
• Employee Assistance Program
• Wellness benefits (financial planning services, mental health counseling, employer paid disability)
• Professional & Personal development resources - LinkedIn Learning, a dedicate training staff in-house, mentoring opportunities & access to leadership development coaches