Manager, Quality Control (QC), Microbiology (Micro) and Environmental Monitoring (EM)

About Forge  

Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping to champion teams that are navigating the long road from the lab bench to the bedside. Our goal is simple but vital to patients living with disease, and we take it seriously. With a patient-first approach, we are forging new models for working together to better accelerate these transformative medicines to reach those who need them the most.   

Forge is based in Columbus, Ohio, in a 200,000 square foot facility known affectionately by team members as, the Hearth. The Hearth, is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services.  

About The Role  

We are currently seeking a Manager, Quality Control (QC), Microbiology (Micro) and Environmental Monitoring (EM) to join the Forge Biologics team.  The Manager, QC, Micro/EM is responsible for overseeing the daily operations of the QC, Micro/EM Department including environmental monitoring testing programs and in-process and product release testing, to ensure compliance with cGMP standards.

What You'll Do:

• Manages the overall operations in the QC Micro Lab, assuring regulatory compliance including State, Federal, and Corporate compliance.
• Responsible for micro testing of raw materials, in-process materials, finished product, and various environment/utility tests.
• Manages EM Program (EM sampling and testing) and EM Analysts.
• Oversees data generated by the QC, Micro/EM team and ensures timely completion of trending reports per required frequency.
• Oversees drafting and execution of EM protocols and studies, gown qualifications and personnel monitoring. (e.g., EMPQ, gown studies, etc.).
• Supports isolator qualifications and biological indicators management.
• Leads corrective action/preventive action (CAPA) for QC, Micro/EM quality events, and reviews corrective actions and assesses implementation of action.
• Develops, implements, and monitors QC, Micro/EM methods and documents (e.g., SOPs, Work Instructions, etc.).
• Assesses and implements continuous improvement of lab efficiency and the EM program.
• Represents the QC Micro/EM function for all external quality and regulatory audits.
• Responsible for GMP compliance, manufacturing quality, laboratory support, and quality planning.
• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback.
• Ensures all documentation is in accordance with GMP and all reported results are accurate.
• Ensures that suitable written records and work undertaken are kept in accord with cGMP and company procedures.
• Complies with U.S. Food and Drug Administration (FDA) regulations, EU GMP and other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Other duties as requested by Quality leadership to support effective laboratory operations and performance metrics.

What You'll Bring:

• Bachelor’s Degree in Biology, Microbiology, or related discipline
• 2-3 years of direct supervisory or management experience
• Experience leading micro/environmental monitoring efforts in a Pharma, Biotech, or regulated/GxP industry
• Good aseptic technique is essential for this position
• Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Ability to present to and interact with Senior Management and Leadership teams

Preferred Skills

• Experience working with contract labs, including contract management, operational oversight, and business process integrations
• Experience with electronic Quality Management Systems (EQMS), Laboratory Information Management Systems (LIMS), etc.
• Experience in high-level interactions with domestic and international Regulatory agencies
• Experience in cell and gene therapy (e.g., AAV manufacturing)
• Experience in compendia microbiological testing methods
• Sterility testing (compendia/rapid microbiological methods)
• Growth promotion testing
• Microbial identifications

Work Environment and Physical Demands  

This position works in both a laboratory environment and 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. 

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. 

 Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. 

Life at Forge  

We are a team of diverse, driven and passionate people working together to trailblaze a new model for how we make medicines to treat patients with genetic diseases. Our team members use their creativity and talent to invent new solutions, meet new demands, and offer the most effective services in the industry. Forge’s core values lay the foundation for H.O.P.E. It provides us a common purpose that we all understand, work towards and live by.  

HARDWORKING - We work hard and smart, making a persistent and determined effort toward success. Working hard, with focus and desire is the key. 

OPEN - We strive to be approachable, actively listen and encourage others to contribute and speak up. We positively offer and receive constructive feedback. 

PURPOSE DRIVEN - We are passionate about working towards and delivering on our mission to manufacture gene therapies. 

ENGAGED - We are fully absorbed by and enthusiastic about our work and take positive action to further Forge’s vision, mission and goals. 

We’ve Got You Covered 

We take the health and happiness of our employees seriously and are consistently evaluating new ways to make our benefits truly UnFORGEttable. 

• Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependents 

• Flexible PTO (plus 14 paid company holidays) 

• Annual bonus for all full-time employees 

• 401(K) company match 

• Fully-stocked kitchen with free food/drinks 

• 12 weeks of paid parental leave - additional discount programs include childcare support & dependent care 

• Employee Assistance Program  

• Wellness benefits (financial planning services, mental health counseling, employer paid disability) 

• Professional & Personal development resources - LinkedIn Learning, a dedicate training staff in-house, mentoring opportunities & access to leadership development coaches