Manager, Quality Control (Analytical)

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:

The Manager, Quality Control (Analytical) provides oversightof in-process and final product testing for AAV vectors, plasmids, and microbial and mammalian cell banks, while ensuring that activities occur in an efficient and cGMP compliant manner.  This position will serve as the subject matter expert (SME) for nucleic acid-based analytical testing within the QC team, with a primary focus on ddPCR and qPCR assays. This role will function as an SME for regulatory inspections, and will responsible for the supervision and management of direct reports within the QC Analytical team.  This role provides an opportunity to play a significant impact in the success of client gene therapy programs.

 

What You'll Do:

• Provide operational management of the Quality Control (QC) analytical team responsible for performing assays relevant to viral vector/gene therapy products, plasmids, and cell banks, including in-process testing, lot release testing, assay qualification, and validations.
• Function as the QC Analytical management team SME for nucleic-acid based analytical testing.
• Ensure adherence to strict regulatory requirements to ensure product quality.
• Collaborate with the Analytical Development (AD) and Manufacturing teams to ensure effective communication between all groups.
• Provide management for and ensure the effective transfer of analytical methods to Quality Control in a phase-appropriate fashion, to support pre-clinical, clinical, and commercial activities.
• Contribute to authoring, reviewing, and approving QC documentation: SOPs, protocols, analytical methods, stability protocols and reports, qualification protocols, sampling plans, and
• Ensure adherence to timelines in support of IND, BLA, and all relevant ex-US regulatory filings.
• Manage and mentor staff to build a highly functional QC team that may be cross-trained in analytical development assay areas, as needed.
• Provide support for Lab Investigations, Deviations, Change Controls, and CAPAs related to in process and final product testing.
• Manage tracking and trending of in process and final product testing data, including, but not limited to; leading/participating in out of specification (OOS)/out of trend (OOT) Laboratory Investigations.
• Ensure all laboratory records adhere to cGMP/GDP expectations.
• Support regulatory and client inspections, and internal audits .

 

What You'll Bring:

• Bachelor's, Master's, or PhD or in a relevant scientific field (e.g., biology, biochemistry, molecular biology)
• Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.
• Experience with the analytical methods used for gene therapy in-process testing, release testing and characterization, with an emphasis on nucleic acid based assays (ddPCR, qPCR).
• SME for nucleic acid based assays (ddPCR, qPCR). Highly beneficial to have advanced knowledge of analytical testing quality control assays, including  ELISA, SDS-PAGE, Western blot, and HPLC, to assess the quality, potency, and safety of AAV vector products.
• Knowledge of cGMP requirements as they pertain to  Quality Control testing.
• Experience with electronic Quality Management Systems (eQMS), Laboratory Information Management Systems (LIMS), etc.
• Experience in support client or regulatory audits. High-level interactions with domestic and international Regulatory agencies is a plus.
• Knowledge of CMC analytical and regulatory requirements

 

Special Knowledge or Skills Preferred:

• Experience with the analytical methods used for gene therapy in-process testing, release testing and characterization, with an emphasis on potency assays.
• Advanced knowledge of cell-based assays, qPCR, HPLC, ELISA, SDS-PAGE, mass spectrometry, and molecular biology techniques.
• Functional knowledge of mammalian cell culture.
• Advanced knowledge of cGMP requirements as they pertain to Analytical Development and Quality Control testing.
• Advanced laboratory skills for analysis of pharmaceuticals, biopharmaceuticals.
• Experience with electronic Quality Management Systems (EQMS), Laboratory Information Management Systems (LIMS), etc.
• Experience in high-level interactions with domestic and international Regulatory agencies.
• Knowledge of CMC analytical and regulatory requirements.
• Small company and/or start-up experience.
• Experience in cell and gene therapy (e.g., AAV manufacturing) is highly desirable.

 

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
• Competitive Paid Time Off plan
• 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)
• Onsite fitness facility
• Professional & Personal development resources