Research & Development Quality Specialist

R&D Quality Specialist

The R&D Quality Specialist plays a critical role in Process Development (PD) for maintaining quality throughout the product development lifecycle by implementing quality control measures, actively managing documentation and samples, and ensuring compliance with regulations and company guidelines, guaranteeing that process development procedures and products meet established quality standards.

About The Role:

The R&D Quality Specialist (Process Development and Late-Stage Process Characterization) role focuses on ensuring product quality throughout the development lifecycle by developing training, implementing quality control measures, and collaborating with cross-functional teams while adhering to regulatory standards and company guidelines. This position will be responsible for training the team on process characterization procedures and SOPs while ensuring that activities occur in an efficient and GDP-compliant manner. The R&D Specialist will work with the Quality department and the Process Development department, ensuring cutting-edge technologies are employed to maintain the highest quality standards for gene therapy products.

What You'll Do:

Work closely with process development research scientists to ensure adherence to quality standards and regulatory requirements.

Know how to use our electronic lab notebook system, Benchling, documentation and training system, Quality Management System (Veeva), and our equipment management system (Blue Mountain Regulatory Asset Manager).

Create a phase-appropriate quality plan in collaboration with the process development team, outlining critical quality attributes, acceptance criteria and testing protocols.

Maintain accurate and detailed documentation of all process characterization activities.

Provide compliance oversight by ensuring adherence to relevant regulatory standards (e.g., FDA, GDP) throughout the process development and characterization phase.

Provide training to PD team members on quality standards and procedures. Ensure the PD group is properly trained including but not limited to appropriate SOPs and work instructions.

Ensure that the equipment that PD group uses is properly inspected, calibrated, and maintained to a level of quality appropriate for process characterization, and that equipment readiness is properly scheduled and documented in BMRAM.

Ensure data used for process characterization is accurate and controlled.

Ensure samples used for process characterization are inventoried accurately and controlled.

Ensure that changes in the PD space, equipment, facility, or procedures are properly documented and controlled as appropriate when relevant to process characterization.

Review study protocols, and technical reports and approve documentation associated with in-process, final product, and stability testing.

Provide technical guidance and mentorship to junior team members, promoting their personal growth and skill development.

Compile data with minimal oversight, reviewing reports, and performing the analysis and interpretation of assay results.

Support regulatory and client inspections and internal audits of lab quality systems.

Manage tracking and trending of in-process and final product testing data in the development space.

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 quality processes and systems.

Proven ability to perform quality reviews on documentation and processes.

Skilled at organization and managing multiple projects simultaneously.

Strong analytical and data interpretation skills to assess and drive quality improvement through the analysis of quality metrics and performance data.

Robust understanding of regulatory requirements as they pertain to process characterization.

Excellent communication and collaboration skills to work effectively with cross-functional teams.

Experience in leading, mentoring, and guiding junior team members.

Strong understanding and experience in Electronic Quality Management Systems (EQMS), Laboratory Information Management Systems (LIMS), and regulatory requirements relevant to the industry.

Experience with electronic Quality Management Systems (EQMS) and laboratory Information Management Systems (LIMS).

Work Environment and Physical Demands

This position works in both a laboratory environment and a 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. 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