Principal Scientist, MS&T Compliance

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 Team

Manufacturing Science and Technology is a team of highly skilled Scientist responsible for the technology transfer of processes developed by Process Development into the GMP Manufacturing area. They are responsible for technical and scientific support for existing clients and internal production. The Manufacturing Science and Technology team develops and implements robust technology transfer, provides data analytics for existing processes and supports continuous improvement of cGMP Manufacturing. Manufacturing Science and Technology interacts with clients through the generation of reports, risk assessments and face to face meetings.

About The Role 

We are currently seeking a Principal Scientist, Manufacturing Science and Technology (MS&T) Compliance to join the Forge Biologics team. This is an exciting opportunity to provide support in compliance for manufacturing activities including process improvements, change management, investigating deviations and root cause analysis. The ideal candidate will be an expert in technical problem-solving, GMP manufacturing techniques, and working with interorganizational teams to support our growth in the Gene Therapy sector. 

What You’ll Do (Responsibilities)

• Plan, perform, and organize investigations activities for process deviations and provide potential impact assessments. 
• For complex investigations, coordinate cross functional team for analysis and review.
• Compose and assist others in the preparation of change controls, deviation descriptions, root cause analysis, corrective actions and preventive actions (CAPA) reports, and assist in the management of compliance records.
• Proactively communicate with internal and external partners the status of investigations.
• Provide training for manufacturing operators to address deviations and CAPAs.
• In close collaboration with Quality, drive the close of Investigations, CAPAs, and Change Controls based upon timelines and SOPs.
• Present Compliance issues and closure strategies to Management/Auditors/Inspectors.
• Identify and assess GMP manufacturing operations for compliance risk.
• Recommend process improvements to enhance Right-First-Time principles and regulatory compliance of cGMP operations.
• Provide guidance on inspection readiness of personnel (training, presentations, responses) and manufacturing areas (equipment, cleanliness, documentation).
• Support in the execution of Gap Assessments and Risk Assessments.
• Provide training to MS&T, Manufacturing, and Manufacturing Support personnel on investigations, including root cause analysis. 
• Other duties as assigned.

What You’ll Bring (Qualifications)

• Bachelor’s degree, in life sciences, engineering or related field and 8+ years of industry experience; Masters degree with 5+ years of industry experience; PhD and 3+ years of direct experience.
• Experience in Process Development, Manufacturing, and/or Manufacturing Science and Technology (MS&T) for cell or gene therapies.
• Strong understanding of cGMP manufacturing, deviation management, change control processes, and continuous improvement methodologies.
• Working understanding of the overall bioprocessing workflow including upstream cell culture, bioreactors, chromatography, centrifugation, ultrafiltration, process analytics, data analysis, various lab and bioprocess equipment.
• Excellent verbal and written communication skills, with the ability to effectively interact with cross-functional teams.
• Strong scientific and engineering aptitude, including demonstrated experience in post-experimental data analysis and data-driven decision making.
• Excellent attention to detail and ability to accurately document, record, and analyze experimental data and manufacturing activities.
• In-depth understanding Quality and regulatory regulations in a biologics Pharma/ Biotech industry.
• Commitment to following SOPs, safety protocols, and regulatory guidelines to ensure compliance and product quality.
• Ability to adapt to changing priorities and work effectively under pressure.
• Experience in training and developing manufacturing and engineering personnel to enhance their skills and knowledge.

Preferred Skills  

• Working knowledge of industry systems (ERP, Veeva), statistical tools (JMP, SIMCA), and advanced experience with business software (i.e. Excel, Visio).

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