Technical Writer I

7 days ago

Columbus, Ohio, United States Forge Biologics Full time
About Forge Biologics

Forge Biologics is a gene therapy development engine that enables access to life-changing gene therapies. We partner with innovators in the gene therapy community to bring transformative medicines to patients in need.

Our goal is to accelerate the development of gene therapies by providing expertise in manufacturing and therapeutics development. We strive to be a leader in the industry by fostering a culture of innovation, collaboration, and excellence.

About the Role

We are seeking a Technical Writer I to join our team in Columbus, Ohio. As a Technical Writer, you will be responsible for authoring, reviewing, and processing documents needed for our operations. You will collaborate with site Subject Matter Experts (SMEs) to transcribe process, procedure, and work instructions into usable documents that support our Quality Management System and adhere to cGMP principles.

The ideal candidate will have a strong background in technical writing, preferably in the pharmaceutical or biotechnology industry. You will have excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams. You will also have a strong attention to detail and be able to manage multiple projects simultaneously.

Key Responsibilities
  • Prepare and update standard operating procedures (SOPs), batch records, protocols, reports, and other technical documents.
  • Collaborate with scientists, engineers, and other subject matter experts to gather information and translate complex technical data into clear, concise documentation.
  • Edit, standardize, or suggest changes to material prepared by other writers or Forge personnel to verify accuracy, consistency, grammar, and format.
  • Observe production, developmental, and experimental activities to determine operating procedure and detail.
  • Manage document versions and revisions, ensuring that the most current and accurate documents are accessible to all relevant stakeholders.
  • Studies drawings, specifications, mockups, and product samples to integrate and delineate technology, operating procedure, and production sequence and detail.
  • Review manufacturer's manuals and trade catalogs, drawings and other data relative to operation, maintenance, and service of equipment.
  • Confer 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 or equivalent work experience.
  • Demonstrated experience with Standard Operating Procedures, Protocols, and Reports.
  • Previous experience in technical writing, preferably in the pharmaceutical, biotechnology, or related industry, is an advantage but not required.
  • Intermediate computer software skills including Microsoft Office, Excel, and PowerPoint for creation and maintenance of documents, filing, organization, planning skills, managing multiple projects, and time management.
  • Experience with Veeva Vault, BMRam or equivalent software preferred, Adobe Acrobat PDF/DC experience is strongly desired.
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.

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.

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