Full-Time

Manager/Associate Manager

Maintenance & Utilities

Posted on 7/14/2025

Forge Biologics

Forge Biologics

201-500 employees

End-to-end manufacturing of AAV gene therapies

No salary listed

Columbus, OH, USA

In Person

Category
Facilities Operations (2)
,
Requirements
  • 8+ years of experience in facility & utility operations, including complex mechanical systems
  • Proven experience supporting facility infrastructure and critical utility systems (e.g., HVAC, boilers, chillers, WFI, clean steam, compressed gases, etc.)
  • Demonstrated experience with equipment lifecycle management and preventive/predictive maintenance strategies
  • Ability to mentor and train staff, set performance expectations, and support employee growth through delegation, feedback and coaching
  • Capable of managing competing priorities and ensuring compliance in a fast-paced, regulated environment
  • Excellent interpersonal and communication skills; ability to influence cross-functional teams and lead through collaboration
  • Proficiency with CMMS platforms (e.g., BMRAM or equivalent)
  • Experience organizing and managing facility shutdown activities
  • Ability to respond to after-hours issues or be on-call as needed
  • May be required to lift up to 50 pounds of materials or equipment
  • Requirement to gown into Classified Areas of the facility (ISO 7 and 8 sterile gowning)
  • The ability to move safely over uneven terrain or in confined spaces
  • The ability to safely climb ladders while carrying 40 pounds
  • The ability to wear personal protective gear correctly as required
Responsibilities
  • Owns the maintenance and inspection of infrastructure systems: fire suppression, site security, landscaping, pest control, building infrastructure (doors, floors, roofing), and GMP cleanroom related infrastructure.
  • Coordinates site support functions, office repairs, and maintains relationships with local agencies.
  • Leads the execution of facility maintenance strategies and capital improvements aligned with the site master plan, including ownership of planned and corrective maintenance programs and building robust maintenance plans in Blue Mountain Regulatory Asset Manager (BMRAM).
  • Monitors trends and alarms from the Building Management System (Metasys) and Building Monitoring System (OceaSoft), reporting findings to equipment owners.
  • Manages the operation, maintenance, and compliance of site utilities: air handlers, exhaust systems, boilers, chillers, RO system, humidifiers, compressed gases, WFI, clean steam, UPS systems, emergency generators and site electrical infrastructure.
  • Develops preventive and predictive maintenance programs and leads daily rounds and troubleshooting of utility systems.
  • Provides mechanical maintenance expertise during project design, installation, and start-up, including support for utility equipment installations and execution of Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
  • Trains and mentors staff, sets performance expectations, and fosters collaboration.
  • Leads planned and corrective work on GMP and non-GMP mechanical equipment, ensuring compliance with Quality and EHSS requirements.
  • Leads major facility and utility maintenance activities during scheduled shutdowns.
  • Implements strategies for the Asset Responsible Care Program and identifies areas for continuous improvement in partnership with Plant & Reliability Engineering.
  • Manages vendor and contractor services for facility and utility system maintenance, ensuring GMP compliance and audit readiness; oversees contracts, evaluates performance, and implements best practices for in-house vs. external work through strong cross-functional collaboration.
  • Develops Job Safety Analyses (JSAs) and supports LOTO and spare parts programs.
  • Supports equipment performance reviews and deviation investigations; develops troubleshooting narratives for equipment systems.
  • Write, edit and review maintenance procedures including WI (Work Instructions) and WPTs (Work Plan Templates).
  • Participates in monthly work order review and reconciliation; ensuring CMMS data integrity.
  • Provides after-hours or on-call support for urgent issues, including BMS alerts.
Desired Qualifications
  • Knowledge of cGMP, FDA, EMA, and/or ISO regulations as they relate to facilities, utilities, and equipment maintenance.
  • Experience in documentation management within a structured Quality System (ISO, FDA).

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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