Forge Biologics

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:

The Manager of Environmental, Health, Safety & Security (EHS&S) is responsible for building, maintaining and enforcing EHS&S policies, programs and procedures at the site. The position ensures that the EHS&S site programs meet all applicable regulatory agency requirements. In addition to leading core EHS&S programs, this role will also take ownership of site-level Sustainability initiatives to drive long-term environmental stewardship and resource efficiency. The individual hired will be responsible for cultivating a high-performance culture through training, employee engagement and a continuous improvement mindset across the site.

What You’ll Do:

• Owns the overall (EHS&S) Environmental, Health, Safety, Security and Sustainability programs at the site
• Develops a strategic vision for site policies and programs that align with corporate structure and governmental (local and state) regulations.
• Strategically builds a 3-5 year plan that prioritizes funding for OpEx and CapEx funds for site, infrastructure and departmental operational EHS&S continuous improvement and compliance initiatives.
• Develops and maintains a multi-year EHS&S roadmap.
• Fosters a collaborative environment and encourages involvement in EHS&S programs and initiatives at the site.
• Enforces EHS&S policies and recommends areas for improvement to site leadership.
• Builds and delivers site wide EHS&S training programs and implements best practices that promote a high performance EHS&S culture.
• Develops site wide EHS&S KPIs (Key Performance Indicators) and works with staff to build departmental specific EHS&S KPIs.
• Acts as the Site Lead for local and governmental EHS&S visits and audits.
• Works closely with Process Owners (i.e. Development, Manufacturing, Supply Chain and Engineering, etc) to build appropriate safety engineering controls and procedures into processes. Ensures that the site is following a rigorous process to embed a safety mindset culture into operational processes and readiness.
• Evaluates Environmental, Health and Safety local and state regulations and ensures site operational and manufacturing processes align with the requirements.
• Participates in the Contractor Management Program and assesses areas for improvement relating to contractor performance for safety and security.
• Supports the overall EHS&S site governance structure and ensures all goals and objectives for each governance team are being managed effectively.
• Supports the site Master Planning effort and ensures that EHS&S principals are carried from the design through implementation.
• Owns EHS&S relevant databases and systems.
• Owns internal corporate and external regulatory reporting processes.
• Maintains applicable environmental permits.
• Establishes Root Cause best practices for EHS&S investigations and ensures corrective actions are implemented in a timely fashion.
• Ability to balance EHS&S compliance requirements with Quality compliance requirements.

What You’ll Bring:

• Bachelor’s degree in a technical field (preferably in Occupational Safety, Process Safety, or a related discipline)
• 10+ years of progressive experience in Environmental, Health, Safety & Security
• Previous experience in a leadership or site-level role
• Experience developing and implementing EHS&S policies, programs and training at a site-level
• Proven knowledge of federal, state, and local EHS regulations (e.g., OSHA, EPA, NFPA)
• Ability to manage multiple priorities, adapt to change, and work independently in a fast-paced environment
• Must be a visionary thinker with the ability to implement robust EHS&S measures into complex biomanufacturing processes
• Excellent interpersonal and communication skills; ability to influence cross-functional teams and lead through collaboration
• Proficient in MS Office and EHS management systems
• Preferred: Experience in documentation management within a structured Quality System (ISO, FDA)
• May require occasional weekend or off-hour work
• Ability to work onsite in Columbus, Ohio 5 days/week

Physical Requirements:

• May be required to lift up to 50 pounds of materials or equipment
• Requirement to gown into Classified Areas of the facility (ISO 7 and 8 sterile gowning)
• The ability to move safely over uneven terrain or in confined spaces
• The ability to safely climb ladders while carrying 40 pounds
• The ability to wear personal protective gear correctly as required

Work Environment and Physical Demands

This position works in both a warehouse and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The noise level in the work environment ranges from moderate to occasionally loud. Must be able to lift, carry, push, and/or pull objects weighing up to 35 lbs. Ability to frequently operate a computer, and communicate with others in person, over the phone, and via other devices. Must be able to move about the facility for moderate to extended periods of time. Ability to wear task dependent personal protective equipment as needed.

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
• Competitive paid time off plan
• 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)
• Onsite fitness facility
• Professional & Personal development resources