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Lead Scientist, Manufacturing Science

2 months ago

Columbus, Ohio, United States Forge Biologics Full time
Job Overview

About Forge Biologics

At Forge Biologics, our commitment is to facilitate access to transformative gene therapies, turning innovative concepts into reality. We collaborate with pioneers in the gene therapy sector, including researchers, healthcare professionals, biotech and pharmaceutical companies, and patient advocacy groups. Our expertise in gene therapy production and therapeutic development is pivotal in guiding teams through the complex journey from laboratory research to clinical application. Our mission is clear and crucial for patients battling diseases, and we approach it with utmost seriousness. With a focus on patient needs, we are pioneering new collaborative models to expedite the delivery of these groundbreaking treatments to those in urgent need.

About Our Team

The Manufacturing Science and Technology (MS&T) team comprises highly qualified scientists responsible for transferring processes developed by Process Development into the Good Manufacturing Practice (GMP) environment. This team provides essential technical and scientific support for ongoing client projects and internal production. The MS&T group is dedicated to creating and executing effective technology transfer strategies, performing data analysis on existing processes, and fostering continuous enhancements in GMP manufacturing. Interaction with clients is a key aspect, facilitated through detailed reports, risk assessments, and direct meetings.

Role Overview

We are seeking a Senior Associate Scientist in Manufacturing Science & Technology (MS&T) to enhance the Forge Biologics team. This role presents an exciting opportunity to contribute to the MS&T strategy within a Cell & Gene Therapy Contract Development and Manufacturing Organization (CDMO). Responsibilities include supporting the development, implementation, and ongoing management of all MS&T initiatives for cell and gene therapy products. As a Senior Associate Scientist in MS&T, you will play a crucial role in ensuring the effective transfer of viral vector processes into GMP production.

Key Responsibilities

  • Facilitate technology transfer from Product Development to Manufacturing, defining critical quality attributes and essential process parameters under cGMP standards.
  • Work collaboratively with cross-functional teams, including clients, Client Development, Technical Sales, Process Development, Manufacturing, Quality, and Program Management, to ensure GMP readiness and provide technical guidance throughout the process.
  • Act as the primary contact for clients during Process Technology Transfers, conducting thorough reviews of client and Process Development processes and generating necessary documentation.
  • Support GMP execution of new processes, addressing any deviations, corrective actions, and change controls as required.
  • Serve as a technical Subject Matter Expert (SME) within the MS&T team, providing assistance for GMP execution, deviation investigations, and compliance with change controls.
  • Conduct process monitoring, including manufacturing data analysis, summarization, and reporting.
  • Identify opportunities for process optimization and efficiency improvements in platform manufacturing processes.
  • Recommend enhancements to MS&T practices and procedures.
  • Ensure compliance of all MS&T activities with relevant regulatory standards, including FDA, cGMP, and international regulations.
  • Assist in the development of related documentation, such as process development plans, manufacturing batch records, and standard operating procedures (SOPs).
  • Monitor the progress of routine manufacturing and technology transfer projects, providing regular updates and proactively identifying operational risks and solutions.
  • Explore new technologies and methodologies to reduce costs, improve timelines, enhance safety, and ensure regulatory compliance.

Qualifications

  • Master's degree in biology, molecular biology, virology, biochemistry, or a related field, or a Bachelor's degree with a minimum of 4 years of relevant experience.
  • Demonstrated experience supporting MS&T teams.
  • Familiarity with FDA, cGMP, and international regulatory standards.
  • Exceptional communication, organizational, and interpersonal skills.
  • Strong problem-solving, decision-making, and leadership capabilities.
  • In alignment with our commitment to employee and customer safety, COVID vaccination is required.

This job description is intended to provide a general overview of the responsibilities and qualifications associated with this position. Duties and responsibilities may evolve or new ones may be assigned as necessary.

Life at Forge

We are a diverse and passionate team dedicated to redefining how we develop medicines for patients with genetic disorders. Our members leverage their creativity and skills to devise innovative solutions, meet emerging demands, and deliver the most effective services in the industry. Forge's core values foster a shared purpose that guides our efforts.

Benefits

  • Comprehensive health, dental, and vision insurance starting on your first day, with a significant portion of premiums covered for employees and their dependents.
  • Unlimited paid time off (PTO) plus 14 paid company holidays.
  • Annual bonuses for all full-time employees.
  • Equity incentive plan.
  • 401(K) with company matching.
  • Fully stocked kitchen with complimentary food and beverages.
  • 12 weeks of paid parental leave, with additional support for childcare and dependent care.
  • Employee Assistance Program.
  • Wellness benefits, including financial planning services, mental health counseling, and employer-paid disability.
  • Resources for professional and personal development, including LinkedIn Learning, dedicated training staff, mentoring opportunities, and access to leadership development coaches.