Forge Biologics
Sr. Scientific Writer
Forge Biologics, Columbus, Ohio, us, 43216
About Forge
Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping 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
This position supports the Quality Control department in developing clear, accurate, and well-organized technical documentation. Working cross-functionally, this role will produce critical documents, ensure formatting consistency, and assist in refining content for ease of understanding and compliance with GxP standards. The ideal candidate thrives in a collaborative, compliance-focused environment and has the attention to detail necessary for quality documentation in a CDMO setting.
What You'll Do
* Draft, review, and update product documentation such as sampling plans, specifications, COAs, COTs, stability protocols, and reports * Write and edit methods, SOPs, qualifications, validations, and tech transfer documentation using clear, plain language * Organize and streamline procedures and forms for improved usability and comprehension * Collaborate closely with QC, QA, and SMEs across all departments to stay informed of laboratory processes and technologies * Ensure consistent formatting, structure, and style across various documents and documentation types * Lead projects independently to ensure that material is complete and accurate: * Maintain a comprehensive project list to ensure timely completion * Translate complex technical information from SMEs into clear, well-organized content * Identify redundancies, gaps, and inconsistencies in documents, consulting with relevant SMEs to resolve * Communicate with clients as needed to verify and clarify information * Aide in training analysts in updates to the documents and procedures, such as creating slides and other written tools as needed * Track documentation throughout its lifecycle stages, from initial drafts through final approvals
* Maintain a quality-driven approach in aligning documentation with regulatory standards and audit requirements * Conduct periodic reviews to identify improvements and standardization opportunities in documentation practices * Provide expertise in technical writing best practices and mentor junior team members as needed
What You'll Bring
* 2-3 years experience in a GxP lab environment, or advanced degree in a relevant scientific field * Demonstrated expertise in technical writing, copy-editing, and document formatting * Strong written and verbal communication skills, with the ability to engage with technical and non-technical stakeholders * Skilled in translating scientific and technical information into clear, concise, and compliant documentation, ensuring alignment with regulatory standards and internal quality requirements * Experience teaching and/or training scientific material and processes * Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems * Experience with biopharmaceutical testing, laboratory procedures, and drafting and following written testing methods * Self-driven and proactive, with a strong ability to work independently while effectively collaborating with cross-functional teams in a fast-paced setting * Proven ability to manage multiple priorities in a dynamic environment, adapting quickly to evolving project needs and timelines * Exceptional organizational and time-management skills to efficiently prioritize tasks, balancing short-term demands with long-term project goals * Familiarity with document management systems and knowledge of Quality Control documentation processes is a plus
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
Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping 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
This position supports the Quality Control department in developing clear, accurate, and well-organized technical documentation. Working cross-functionally, this role will produce critical documents, ensure formatting consistency, and assist in refining content for ease of understanding and compliance with GxP standards. The ideal candidate thrives in a collaborative, compliance-focused environment and has the attention to detail necessary for quality documentation in a CDMO setting.
What You'll Do
* Draft, review, and update product documentation such as sampling plans, specifications, COAs, COTs, stability protocols, and reports * Write and edit methods, SOPs, qualifications, validations, and tech transfer documentation using clear, plain language * Organize and streamline procedures and forms for improved usability and comprehension * Collaborate closely with QC, QA, and SMEs across all departments to stay informed of laboratory processes and technologies * Ensure consistent formatting, structure, and style across various documents and documentation types * Lead projects independently to ensure that material is complete and accurate: * Maintain a comprehensive project list to ensure timely completion * Translate complex technical information from SMEs into clear, well-organized content * Identify redundancies, gaps, and inconsistencies in documents, consulting with relevant SMEs to resolve * Communicate with clients as needed to verify and clarify information * Aide in training analysts in updates to the documents and procedures, such as creating slides and other written tools as needed * Track documentation throughout its lifecycle stages, from initial drafts through final approvals
* Maintain a quality-driven approach in aligning documentation with regulatory standards and audit requirements * Conduct periodic reviews to identify improvements and standardization opportunities in documentation practices * Provide expertise in technical writing best practices and mentor junior team members as needed
What You'll Bring
* 2-3 years experience in a GxP lab environment, or advanced degree in a relevant scientific field * Demonstrated expertise in technical writing, copy-editing, and document formatting * Strong written and verbal communication skills, with the ability to engage with technical and non-technical stakeholders * Skilled in translating scientific and technical information into clear, concise, and compliant documentation, ensuring alignment with regulatory standards and internal quality requirements * Experience teaching and/or training scientific material and processes * Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems * Experience with biopharmaceutical testing, laboratory procedures, and drafting and following written testing methods * Self-driven and proactive, with a strong ability to work independently while effectively collaborating with cross-functional teams in a fast-paced setting * Proven ability to manage multiple priorities in a dynamic environment, adapting quickly to evolving project needs and timelines * Exceptional organizational and time-management skills to efficiently prioritize tasks, balancing short-term demands with long-term project goals * Familiarity with document management systems and knowledge of Quality Control documentation processes is a plus
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