Full-Time

Technical Training Manager

GMP Manufacturing

Posted on 10/1/2025

Forge Biologics

Forge Biologics

201-500 employees

End-to-end manufacturing of AAV gene therapies

No salary listed

Columbus, OH, USA

Hybrid

On-site in Columbus, OH 3-4 days per week.

Category
Training
Requirements
  • Associate’s degree in Life Sciences, Biotechnology, or a related technical field required; Bachelor’s degree strongly preferred. Equivalent experience may be considered.
  • Minimum 3-5 years of experience in GMP-regulated manufacturing (biotech, pharmaceutical, or medical device), with advanced knowledge of AAV bioprocess manufacturing and aseptic techniques/practices.
  • Demonstrated experience leading training activities, mentoring associates, and serving as a recognized Subject Matter Expert within Manufacturing operations.
  • Proven ability to deliver hands-on, on-the-job training and conduct qualification assessments in compliance with GMP/GDP requirements.
  • Advanced communication and facilitation skills, with the ability to simplify complex technical concepts and engage diverse audiences.
  • Experience working cross-functionally with Manufacturing, Quality, Process Development, and Training teams to align training with both business objectives and compliance requirements.
  • Strong organizational and leadership skills, with the ability to manage multiple training priorities and influence program outcomes.
  • Knowledge of adult learning principles and training design methodologies (e.g., ADDIE).
  • Ability to work onsite in Columbus, Ohio 3-4 days/week on average.
  • Ability to work in a cleanroom environment, that requires wearing full Personal Protective Equipment (PPE), including gowns, gloves, masks, and safety glasses.
Responsibilities
  • Serve as a subject matter expert and technical lead for GMP Manufacturing operations, owning the delivery of training through classroom instruction, one-on-one coaching, and hands-on, on-the-job practice.
  • Mentor associates throughout their development, actively observe and evaluate performance, and ensure their successful transition to independent work.
  • Coordinate and lead qualification and requalification activities by assessing proficiency, verifying proper execution of GMP-regulated processes, and ensuring all results are accurately documented in compliance with GDP.
  • Take ownership of Manufacturing training program compliance by providing clear, actionable feedback to downstream associates and management on training progress, performance observations, and identified gaps.
  • Be accountable for upholding GMP/GDP expectations through accurate qualification documentation and consistent reinforcement of training standards.
  • Be cross-trained in the Training Management System (e.g., Veeva Vault) to provide oversight and ensure accuracy in recordkeeping, compliance tracking, and reporting when required.
  • Take ownership of developing and maintaining training programs that directly support downstream Manufacturing, working in close partnership with Manufacturing leadership and the Training team.
  • Lead the design of area-specific training content, on-the-job training initiatives, and qualification processes to ensure associates are fully prepared for independent work.
  • Own the revisions, updates, and periodic reviews of training materials, ensuring they remain current with SOPs, process changes, and continuous improvement activities.
  • Take ownership of continuous improvement within training programs by monitoring effectiveness, proactively communicating findings to leadership, and driving remediation or enhancements where needed.
  • Identify training gaps, recommend improvements, and implement stronger training methods to elevate associate performance and compliance.
  • Maintain gowning and downstream manufacturing process qualifications to serve as a subject matter expert and technical lead during training activities, ensuring associates are consistently prepared for independent work.
Desired Qualifications
  • Demonstrated success in leading training initiatives, mentoring associates, and serving as a recognized SME within GMP-regulated environments.
  • Expertise in AAV bioprocess manufacturing, including cell culture operations, aseptic techniques, and cleanroom behaviors.
  • Proficiency with electronic training systems such as Veeva Vault or similar platforms, with the ability to interpret and leverage training data.
  • Proven ability to identify training gaps, recommend improvements, and implement enhancements that strengthen program effectiveness.
  • This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that may change or new ones may be assigned.

Forge Biologics provides end-to-end development and manufacturing for gene therapies, using its gene therapy development engine to move ideas from the lab into scalable production. It focuses on AAV-based therapies and operates from Hearth, a large cGMP facility designed for manufacturing at scale. Revenue comes from offering manufacturing services to other companies and researchers, while also developing its own therapies for potential future products. Its goal is to become a leading, integrated manufacturing partner for gene therapies, helping rare genetic-disease programs reach the clinic and market.

Company Size

201-500

Company Stage

Acquired

Total Funding

$870M

Headquarters

Columbus, Ohio

Founded

2020

Simplify Jobs

Simplify's Take

What believers are saying

  • Eight ASGCT presentations in May 2025 highlight FUEL™ manufacturing innovations.
  • John Maslowski became CEO on October 1, 2024, driving commercial growth.
  • Partnerships with Affinia, Progeria Foundation, and Fractyl expand revenue pipelines.

What critics are saying

  • Ajinomoto diverts resources to larger CDMOs, diluting Forge's AAV focus within 12-24 months.
  • Hearth facility saturates from Progeria, Affinia, Fractyl partnerships, delaying production in 12-18 months.
  • Catalent's $16.5B acquisition floods AAV capacity, undercutting Forge pricing in 6-12 months.

What makes Forge Biologics unique

  • FUEL™ platform boosts AAV productivity, recovery, and quality using Ignition Cells™ and pEMBR™ 2.0.
  • 200,000 sq ft Hearth facility houses 20 cGMP suites with 20,000L bioreactor capacity.
  • End-to-end services span plasmid DNA, AAV manufacturing, and regulatory support.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Unlimited Paid Time Off

401(k) Company Match

Annual Bonus

Paid Parental Leave

Employee Assistance Program

Wellness Program

Onsite Fitness Facility

Company News

University of Pittsburgh
Apr 22nd, 2026
Innovation Institute Reports Record Number of Invention Disclosures, Despite Pandemic

From swimming devices to rare disease gene therapies, Pitt inventors never stop: The Innovation Institute reported a record 394 invention disclosures for last fiscal year, and Director Evan Facher says another robust year is ahead.

Contract Pharma
Mar 3rd, 2026
Progeria Research Foundation, Forge Biologics Enter Gene Therapy Mfg. Pact

Progeria Research Foundation, Forge Biologics enter gene therapy mfg. Pact. Forge Biologics will provide process development and manufacturing services to support gene therapy for ultrarare disease. March 3, 2026 Managing Editor, Contract Pharma The Progeria Research Foundation (PRF), a research organization developing treatments for Hutchinson-Gilford Progeria Syndrome, and Forge Biologics, a manufacturer of gene therapies, entered a manufacturing agreement to support the development and manufacture of SamPro-2, PRF's investigational gene therapy for adolescence with Progeria, an ultrarare and fatal genetic disease characterized by rapid aging. The manufacturing agreement leverages PRF's research-driven Progeria program with Forge's integrated gene therapy capabilities including process development, cGMP manufacturing, FUEL platform technologies, and regulatory consultation. Forge will provide manufacturing services for Investigative New Drug (IND)-enabling studies with SamPro-2, a gene therapy that uses adeno-associated virus (AAV), a commonly utilized delivery vehicle in gene therapy, to deliver a base editing approach designed to correct the single DNA base mutation in the lamin A gene that causes Progeria. "Behind every program like this are patients and families who have waited a long time for progress," said John Maslowski, president and chief executive officer of Forge Biologics. "The Progeria Research Foundation and its Gene Team have shown extraordinary dedication to advancing this science, and we are honored to partner with them. At Forge, we bring that same level of care, expertise, and technical rigor to our manufacturing work as we help advance this program for patients."

PharmaSource
May 15th, 2025
Forge Biologics Partners with Fractyl Health on AAV Manufacturing for Metabolic Gene Therapy

Forge Biologics partners with Fractyl Health on AAV manufacturing for metabolic gene therapy.

BioSpace
May 14th, 2025
Forge Biologics Announces Eight Presentations At The American Society Of Gene And Cell Therapy (Asgct) 28Th Annual Meeting

Oral and poster presentations will highlight data demonstrating the enhanced productivity, recovery, and consistent quality of Forge’s FUEL™ AAV manufacturing platform, addressing the industry's need for more efficient manufacturingCOLUMBUS, Ohio--(BUSINESS WIRE)--Forge Biologics (“Forge”), a leading manufacturer of genetic medicines and member of the Ajinomoto Bio-Pharma Services group, today announced that it will deliver eight presentations at the upcoming American Society of Gene and Cell Therapy (ASGCT) 28th Annual Meeting, taking place May 13-17, 2025 in New Orleans, Louisiana. The presentations include two technical session presentations, an oral presentation, and five scientific posters focused on Forge’s FUEL™ platform and manufacturing innovations for gene therapies.“We’re proud to share Forge’s latest manufacturing advancements, underscoring our commitment to innovation as we help clients deliver transformative gene therapies to patients,” said John Maslowski, CEO and President of Forge. “Our experts will highlight how the FUEL™ AAV manufacturing platform, with its advanced technologies and product-specific optimizations, drives significant productivity gains. We’re also excited to present additional talks and posters on key analytical advances as we look toward a future of faster and more comprehensive analytics for product release.”SESSION PRESENTATIONSSponsored Symposium. Title: “Great Science Needs Innovative Manufacturing Technology”. Presenters:David Dismuke, Ph.D., Chief Technology Officer

BioProcess International
Nov 15th, 2024
Affinia and Forge team up to tackle cardiovascular diseases

Affinia Therapeutics announced that it is partnering with Forge Biologics to manufacture clinical trial material under GMP standards.

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