Analyst I, Quality Control

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 Quality Control (QC) Analyst to join the Forge Biologics team. This is an exciting opportunity to help lead the laboratory efforts and execute characterization testing and assays for Quality Control. The candidate will optimize existing and implement new technologies and systems into Quality Control for research and GMP purposes. The ideal candidate will be skilled in technical problem-solving and laboratory techniques to support our growth in the Gene Therapy sector.

The QC Analyst provides Biochemistry and/or Molecular Biological expertise for the Forge GMP facility in Grove City, OH. This will include technical writing, routine testing, and all other associated activities. The QC Analyst responsibilities include, but are not limited to; training, sampling, routine testing, method qualification/validations, and investigations. Additional responsibilities include adherence to all GMP requirements, a basic understanding of FDA/EMEA regulations, and effective interactions/communication with Quality Management. The QC Analyst may also support the QC management team for activities related to interviewing and training of employees, compliance with GMP, and identifying and implementing corrective and preventive actions.

Prior experience/specialized skills may result in additional responsibilities and/or development opportunities. The QC Analyst may be responsible for performing the in-process and release testing for our most advanced AAV-based (viral vector) therapeutic candidates generated from the PD, research, and GMP laboratories, as well as raw materials, to ensure they conform to manufacturer specifications. The QC Analyst will execute the procedures designed to demonstrate safety, efficacy, and purity of the drug products under evaluation. The QC Analyst may be responsible for upstream (cell culture and virus production) and downstream (harvest and purification) testing activities to support a singular "platform" process for the entire AAV program portfolio.

What You'll Do:

• Conducts Biochemistry and Molecular Biological testing that incorporates application of GMP principles and methodologies.
• Conducts thorough investigations to determine root cause of OOS investigations and other non-conforming results and implements appropriate corrective and preventative actions in a timely manner.
• Drafts and revises process documents, assay methods, and sampling plans.
• Trains junior staff in laboratory skills and scheduling lab/equipment maintenance.
• Plans work to meet production and schedule requirements from clients (internal and external).
• Prepares and presents data associated with manufacturing processes and transfer activities to clients.
• May serve as the Person-in-Plant (PIP) support during manufacturing campaigns.
• Reviews and trends QC data (molecular biology and/or biochemistry) and publishes trend reports on a routine basis.
• Supports internal process transfer activities and serves as Subject Matter Expert (SME) to troubleshoot processes/assay. May also represent QC as a SME during audits and inspections.
• Delivers results in a high paced environment.
• Supports packaging and shipping finished product and/or coordinates the effort.
• Additional responsibilities not listed may be assigned as needed by management.

What You'll Bring:

• Minimum Bachelor's Degree (B.A. or B.S.) in Molecular Biology, Biochemistry, Biotechnology, Microbiology, or equivalent industry experience.
• Experience in a Quality Control laboratory or GMP laboratory is preferred but not required
• Must be self-motivating, organized, and proactive.
• Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems.
• Ability to work flexible hours necessary to support production and/or product transfer activities.
• Ability to work in confined spaces and near operating equipment.
• Ability to work in loud noise environments and in Personal Protective Equipment (PPE) and Clean Room gowning attire as needed.
• Travel on an infrequent basis is required (5%) to support job responsibilities and commitments.
• In our commitment to safety of our employees and customers a COVID vaccination is required.

Preferred Skills:

• Detailed/Demonstrated knowledge and understanding of GMP regulations and Food and Drug Administration (FDA) requirements.
• Experience with an electronic Document Management System.
• Working knowledge of global pharmacopeias such as USP, EP, JP, BP, Ph. Eur.
• Knowledge of biopharmaceutical manufacturing process workflows.
• Knowledge in the following system(s): Cell Culture, Cell-based assays, Pharmaceutical Utilities, HPLC, LC/MS, Microbial testing and identification, Mass Spectrometry, AUC, qPCR and ddPCR, ELISA, gel electrophoresis.

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