Associate Scientist II, Manufacturing Science and Technology(Downstream)

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.   

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

What You’ll Do (Responsibilities)

• Assist Technology transfers from Product Development to Manufacturing. Working with MS&T Scientists 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

• Provide support for GMP execution, deviation investigations, CAPAs, and change controls

• Perform process monitoring (manufacturing data analysis, summary, and presentation), assist with 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 2+ 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

Work Environment and Physical Demands   

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