Forge Biologics

Forge Biologics

Lead GMP Technician, Downstream

Columbus, Ohio · Full-time

Sponsorship not specifiedDetected 8 days ago
Process ImprovementClinical Laboratory TechniquesGMPCRISPRLeadershipProblem SolvingMentoringWriting

About the role

  • This is an exciting opportunity to provide active leadership and execution of the Standard Operating Procedures and Master Production Records for downstream manufacturing processes within Forge's state-of-the-art cleanroom facility.

Responsibilities

  • Lead downstream operations for the purification of viral-based vectors related to gene therapy GMP in a cleanroom environment.
  • Collaborate with MS&T to support internal process transfer activities from Process Development to GMP.
  • Collaborate with Quality Systems, including QA and QC, to work toward efforts that satisfy GMP regulations and guidances.
  • perform periodic review of direct reports.
  • Partner with the Technical Writing team to draft, revise, and review GMP documentation.
  • Train and mentor junior technicians; perform periodic review of direct reports.
  • The role will manage a team of technicians at various levels who implement and perform downstream operations, interacting with clients to complete projects for viral vector purification methods according to client specifications.

Requirements

  • 4+ years of relevant experience in downstream GMP manufacturing, with additional preference for relevant BS or MS degrees
  • Demonstrated experience in downstream techniques, including column packing/testing, tangential flow filtration (TFF), and affinity/anion exchange chromatography
  • Proficiency in purification processes, such as chromatography, filtration, and centrifugation, with a proven ability to operate and troubleshoot equipment in downstream GMP manufacturing environments
  • Working knowledge of cGMP requirements and biological drug development
  • Must be self-motivating, organized, and proactive
  • Ability to work in loud noise environments and in Personal Protective Equipment (PPE)
  • This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee.
  • This position works in both a laboratory environment and a typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job.
  • Ability to work the hours necessary to support production and/or product transfer activities
  • 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.
  • This position works in both a laboratory environment and a typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area. Must be able to lift heavy objects up to 50 lbs.
  • This role requires scheduling flexibility to support GMP manufacturing operations, including the ability to flex hours, work weekends or holidays, and adapt to changing shift assignments based on production demands. Shift schedules may change with limited notice, and work assignments will be determined according to business needs to ensure uninterrupted manufacturing support. The position also requires the ability to complete intermediate mathematical equations, including calculations related to buffer preparation, dilution factors, unit conversions, and process parameter adjustments, performed accurately and consistently in accordance with cGMP expectations.

Nice to have

  • Preferred Skills:

Skills

  • Working knowledge of aseptic techniques and automated systems
  • Experience with gene therapy manufacturing and proficiency in using single-use technologies within a GMP downstream processing environment
  • Duties, responsibilities and activities may change, or new ones may be assigned.
  • Work Environment and Physical Demands
  • The employee will be stationary (standing/sitting) for extended periods of time.
  • Employees regularly wear personal protective equipment based on the task being performed.
  • Must be able to work in a confined space, such as a clean room or laboratory environment.
  • Must be able to lift heavy objects up to 50 lbs.
  • We've Got You Covered:
  • Health from day one
  • Time to recharge
  • A competitive paid time off plan - because rest fuels innovation.

Compensation

  • We've built a comprehensive compensation and benefits package designed to help you thrive, grow, and feel valued every step of the way:

Benefits

  • Health, dental and vision insurance start your first day - with 90% of premiums covered for you and your family.
  • 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.
  • Mental health counseling and financial plann
  • Onsite fitness facility at The Hearth.

Company info

  • to enable access to life-changing gene therapies and help bring them from ideas into reality.
  • We partner with scientists, physicians, biotech and pharma innovators, and patient communities - all united by one goal: improving lives.
  • If you're driven by purpose and excited to make a tangible impact, this is where your journey begins.
  • Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio.
  • Here, you won't just watch innovation happen - you'll be part of it.
  • Whether you're scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, you'll play a key role in bringing hope to patients with genetic diseases.
  • What sets Forge apart is our culture of H.O.P.E. We are hardworking, showing up each day with determination and grit.
  • We are open, creating a space where ideas flow freely, and every voice is valued.
  • We are purpose-driven, with every task directly tied to changing lives.
  • And we are engaged, energized by the challenges we face and the milestones we achieve together.
  • At Forge, your growth matters.
  • We're committed to helping you expand your skills, take on new challenges, and develop your career through mentorship, hands-on learning, and opportunities for advancement.
  • Our people are our greatest investment, and we're proud to see team members grow with us.
  • If you're ready to use your talent to help deliver hope to patients around the world, join us - and be part of something bigger than yourself.
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This listing is sourced directly from Forge Biologics's careers page and normalized into a canonical job model.