Senior Associate Scientist, MS&T

Job Description

Job Description

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 Senior Associate Scientist, Manufacturing, Science & Technology (MS&T) to join the Forge Biologics Team.

This is an exciting opportunity to support the MS&T strategy for a Cell & Gene Therapy Contract Development and Manufacturing Organization (CDMO).

This includes supporting the development, implementation, and maintenance of all MS&T activities for cell & gene therapy products.

As a Senior Associate Scientist in MS&T, you will be responsible for the successful transfer of viral vector processes into GMP production.

What You'll Do (Responsibilities)

• Provide Technology transfer from Product Development to Manufacturing. Including defining critical quality attributes, process parameters and conditions of critical importance to manufacturing under cGMPs.
• Collaborate closely with cross-functional teams, including clients, Client Development, Technical Sales, Process Development, Manufacturing, Quality, and Program Management, to ensure GMP readiness and provide technical expertise throughout the process
• Assist with client-facing functional Lead for Process Technology Transfers by performing detailed review of clients and Process Development process and generates technology transfer documents
• Support to General Manufacturing Practices (GMP) execution of the new processes and any deviation investigations, Corrective Action Prevention Plans (CAPAs), and necessary change controls
• Act as a technical Subject Matter Expert (SME) within the MS&T group and provide support for GMP execution, deviation investigations, CAPAs, and change controls
• Perform process monitoring (manufacturing data analysis, summary, and presentation), author campaign summary reports.
• Provides Product Development and Manufacturing with opportunities for process optimization and efficiency enhancements platform manufacturing process.
• Recommends improvements for MS&T practices and procedures
• Ensure all MS&T activities are in compliance with applicable regulatory requirements, including FDA, cGMP, and international regulatory requirements
• Support the development of related documents such as process development plans, manufacturing batch records, and SOPs
• Tracks progress of routine manufacturing and tech transfer projects against schedule, provides routine updates and proactively identifies operational risks and remediation.
• Investigate new technologies and techniques to reduce costs, improve timelines, enhance safety, and improve regulatory compliance.

What You'll Bring (Qualifications)

• Master's degree in biology, molecular biology, virology, biochemistry or related discipline, or Bachelor's degree with 4+ years' relevant experience
• Proven track record in supporting MS&T teams
• Knowledge of FDA, cGMP, and international regulatory requirements
• Excellent communication, organizational, and interpersonal skills
• Strong problem-solving, decision-making, and leadership skills
• In our commitment to safety of our employees and customers a COVID vaccination is require

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.

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

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

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

E NGAGED - 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 Un FORGE ttable.

• 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
• Unlimited PTO (plus 14 paid company holidays)
• Annual bonus for all full-time employees
• Equity-incentive plan
• 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
30+ days ago