About The Role:

The Scientist I, Quality Control (Analytical) role will primarily focus on analytical method execution, method qualification, method validation, and troubleshooting efforts. This position will be responsible for executing in-process, final product, and stability testing for AAV vectors, plasmids, and microbial and mammalian cell banks, while ensuring that activities occur in an efficient and cGMP compliant manner. This role will function as a subject matter expert (SME) for either nucleic acid-based methods (e.g. ddPCR, qPCR) or protein-based assays (e.g. CE, AUC). This position will also be responsible for fostering innovation within the QC department, either independently or by partnering with Analytical Development, ensuring cutting edge technologies are employed to maintain the highest QC standards in the analysis of gene therapy products. This role provides an opportunity to play a significant impact in the success of client gene therapy programs.

What You'll Do:

• Perform in-process, release, and stability testing for 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 an SME for either nucleic acid-based methods (e.g. ddPCR, qPCR) or protein-based assays (e.g. CE, AUC). Additionally, perform advanced analytical testing quality control assays, including cell-based infectivity assays, potency assays, qPCR, ELISA, and viability assays, to assess the quality, potency, and safety of AAV vector products.
• Support troubleshooting of processes/assays as an SME. Represent QC as a SME during audits and inspections.
• Ensure effective qualifications, validations, and transfer of analytical methods to Quality Control in a phase-appropriate fashion, to support pre-clinical, clinical, and commercial activities.
• Contribute to authoring and/or reviewing QC documentation, including but not limited to: SOPs, analytical methods and forms, qualifications protocols, and validation protocols.
• 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.
• Provide support for Deviations, Change Controls, and CAPAs related to in process and final product testing.
• Review and approve GMP documentation associated with in process, final product, and stability testing.
• Drive the development, optimization, and validation of novel analytical methods to enhance quality control processes.
• Provide technical guidance and mentorship to junior team members, promoting their personal growth and skill development.
• Compile data with minimal oversight, generating reports, and archiving assay data; responsible for performing the analysis and interpretation of assay results.
• Support regulatory and client inspections and internal audits of GMP systems.
• 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.

What You'll Bring:

• Bachelor's, Master's, or PhD or in a relevant scientific field (e.g., biology, biochemistry, molecular biology). Advanced degree preferred.
• SME for either nucleic acid-based methods (e.g. ddPCR, qPCR) or protein-based assays (e.g. CE, AUC) based on experience. Advanced knowledge of complex molecular biology, biochemistry, or cell biology techniques and analytical methods (e.g., qPCR, cell-based infectivity assays, potency assays).
• Proven ability to execute, troubleshoot, and optimize analytical assays.
• Strong analytical and data interpretation skills to assess and drive quality improvement through the analysis of quality metrics and performance data.
• Robust understanding of cGMP requirements as they pertain to Quality Control and Analytical Development testing.
• Experience in leading, mentoring, and guiding junior team members.
• Experience with electronic Quality Management Systems (EQMS), Laboratory Information Management Systems (LIMS), etc.

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