Senior Associate Scientist, MS&T

Forge BiologicsColumbus, OH
1dOnsite

About The Position

As an Associate Scientist II Senior Associate Scientist, MS&T, you will play a key role in developing, optimizing, and supporting gene therapy manufacturing processes within the Manufacturing Science and Technology (MS&T) department. This multidisciplinary role collaborates closely with process development, manufacturing, quality, validation, facilities and engineering, and regulatory teams to ensure upstream, downstream, fill‑finish, buffer preparation, and support‑function processes are scalable, robust, and aligned with regulatory expectations. As a reliable independent contributor, you will execute moderately complex, recurring assignments, adapting established procedures to varied situations and identifying refinements that enhance consistency and performance. You will help identify minor process gaps, support continuous improvement initiatives, and strengthen overall operational reliability, while also training peers on foundational tasks and occasionally influencing adjacent functions. Through this work, you will contribute to day‑to‑day operational excellence, team deadlines, audit readiness, and quality outcomes, playing a meaningful role in the organization’s broader success.

Requirements

  • Bachelor’s degree in a relevant scientific discipline with 3+ years of directly related industry experience
  • Behaves ethically and in alignment with organizational values, showing strong communication, organizational, interpersonal, and emerging problem‑solving skills
  • Demonstrates growing independence by identifying minor issues or opportunities, proactively seeking feedback, and expressing ideas effectively in both written and verbal formats
  • Collaborates effectively by training teammates, completing assigned tasks, and contributing constructively to group discussions

Nice To Haves

  • Experience working with viral vectors (AAV, Lentivirus, etc.) in a GMP setup.
  • Proven track record in supporting tech transfers.

Responsibilities

  • Serve as a technical contributor during technology transfer activities from Process Development or clients into GMP Manufacturing, including defining critical quality attributes, key process parameters, and conditions essential for compliant manufacturing under cGMPs.
  • Lead the development, review, and maintenance of key documentation such as manufacturing batch records, production plans, bills of materials and SOPs.
  • Perform process monitoring by collecting, analyzing, and summarizing manufacturing data; prepare campaign summary reports and provide insights that strengthen process understanding and operational decision‑making
  • Support GMP execution of new processes and act as a Subject Matter Expert (SME) for change controls, deviation investigations, and CAPAs.
  • Track progress of routine manufacturing and technology transfer activities, provide timely updates, and proactively identify operational risks and mitigation strategies.
  • Build strong working relationships with internal teams and external clients, communicating responsibilities, expectations, and technical information clearly and respectfully to ensure GMP readiness and provide technical support throughout production campaigns.
  • Train peers on foundational tasks and demonstrate increasing independence in supporting client programs, addressing production challenges, and advancing process understanding within MS&T.
  • Identify and recommend opportunities for process optimization, efficiency improvements, and enhancements to MS&T practices, procedures, and platform manufacturing processes.

Benefits

  • Health, dental and vision insurance start your first day – with 90% of premiums covered for you and your family.
  • A competitive paid time off plan – because rest fuels innovation.
  • 12 weeks of fully paid parental leave so you can focus on family when it matters most.
  • Annual bonus opportunities for all full-time team members.
  • 401(k) with company match to help you plan for the future.
  • Special employee discounts, including childcare and dependent care savings.
  • Onsite fitness facility at The Hearth.
  • Mental health counseling and financial planning services through our Employee Assistance Program.
  • Employer-paid short and long-term disability coverage to protect your peace of mind.
  • A fully stocked kitchen with free snacks and beverages – we keep you energized and ready for what’s next.
  • Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.
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