Lead Scientist, Manufacturing Science

2 weeks ago

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

About Forge Biologics

At Forge Biologics, our mission is to facilitate access to transformative gene therapies, turning innovative ideas into reality. We collaborate with pioneers in the gene therapy sector, including scientists, healthcare professionals, biotech and pharmaceutical companies, and patient advocacy groups. Our expertise in gene therapy manufacturing and therapeutic development is essential as we guide teams through the complex journey from laboratory to patient care. Our patient-centric approach drives us to create new collaborative models that expedite the delivery of these vital treatments to those in need.

About the Team

The Manufacturing Science and Technology (MS&T) team comprises highly skilled scientists dedicated to the technology transfer of processes developed by Process Development into the GMP manufacturing environment. This team provides technical and scientific support for ongoing projects and internal production, focusing on robust technology transfer, data analytics for existing processes, and continuous improvement of cGMP manufacturing practices. Interaction with clients is a key aspect, involving the generation of reports, risk assessments, and direct communication.

About the Role

We are seeking a Senior Associate Scientist in Manufacturing Science & Technology (MS&T) to contribute to our strategic initiatives within a Cell & Gene Therapy Contract Development and Manufacturing Organization (CDMO). This role involves supporting the development, implementation, and maintenance of all MS&T activities related to cell and gene therapy products. As a Senior Associate Scientist, you will play a crucial role in the successful transfer of viral vector processes into GMP production.

Key Responsibilities

  • Facilitate technology transfer from Product Development to Manufacturing, defining critical quality attributes and process parameters essential for cGMP manufacturing.
  • 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 expertise.
  • Serve as the functional lead for Process Technology Transfers, conducting thorough reviews of client and Process Development processes, and generating necessary documentation.
  • Support the execution of General Manufacturing Practices (GMP) for new processes, including deviation investigations, Corrective Action Prevention Plans (CAPAs), and change controls.
  • Act as a technical Subject Matter Expert (SME) within the MS&T group, offering support for GMP execution, deviation investigations, CAPAs, and change controls.
  • Conduct process monitoring, including manufacturing data analysis, summarization, and reporting.
  • Identify opportunities for process optimization and efficiency enhancements in platform manufacturing processes.
  • Recommend improvements for MS&T practices and procedures.
  • Ensure compliance with applicable regulatory requirements, including FDA, cGMP, and international standards.
  • Assist in the development of related documentation such as process development plans, manufacturing batch records, and standard operating procedures (SOPs).
  • Track the progress of routine manufacturing and technology transfer projects, providing updates and identifying operational risks.
  • 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 4+ years of relevant experience.
  • Demonstrated experience supporting MS&T teams.
  • Familiarity with FDA, cGMP, and international regulatory requirements.
  • Strong communication, organizational, and interpersonal skills.
  • Proficient problem-solving, decision-making, and leadership abilities.
  • COVID vaccination is required to ensure the safety of employees and customers.

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

Life at Forge

We are a diverse and passionate team committed to redefining how we develop medicines for patients with genetic diseases. Our team members leverage their creativity and expertise to devise innovative solutions, meet emerging demands, and deliver the most effective services in the industry. Forge's core values underpin our commitment to H.O.P.E., guiding our collective efforts towards a shared purpose.

Benefits

  • Comprehensive health, dental, and vision insurance, effective from day one, with 90% of premiums covered for employees and their dependents.
  • Unlimited paid time off (PTO) along with 14 paid company holidays.
  • Annual bonus program for all full-time employees.
  • Equity-incentive plan.
  • 401(K) company matching.
  • Fully-stocked kitchen with complimentary food and beverages.
  • 12 weeks of paid parental leave, with additional support programs 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.

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