Summary: We are seeking a
Director, Quality Control (Raw Materials) to join the Forge Biologics team. The Director of Quality Control (QC), Raw Materials (RM) will actively contribute to the strategic, operational, and laboratory activities required to support the development and management of the raw material testing program. The Director manages the QC Raw Materials department and will collaborate with internal Manufacturing, Supply Chain, Facilities, and Quality Senior Management, as well as external suppliers, to address quality-related issues. This role will also support continued development of phase-appropriate raw material qualification, laboratory readiness, external testing oversight, and inspection-ready quality systems to support pre-clinical, clinical, and commercial manufacturing activities.
Responsibilities: - Provides strategic and operational leadership to a Quality Control department responsible for raw material sample receipt, incoming inspection and testing, and release of all starting materials (raw materials, consumables, etc.).
- Provides strategic leadership and guidance to the organization to develop and implement a material qualification program in a phase-appropriate fashion, to support pre-clinical, clinical, and commercial activities.
- Remains current on new technologies, and regulatory requirements that may have an impact on the company's development, while ensuring adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
- Accountable for ensuring adherence to strict regulatory requirements to ensure product quality.
- Contributes to authoring and/or reviewing QC reports, SOPs, QC protocols, comparability protocols and reports, and justification of specifications.
- Works directly with Leadership and Senior Management to ensure process communications are occurring in a timely manner, and budget and timelines are being adhered to.
- Serve as a Subject matter expert (SME) for raw materials issues, providing technical expertise aligned with current GMPs and current industry best practices.
- Participates in the Engineering effort (i.e., CAPEX) to assure analytical equipment and supporting materials are in place and meet GMP requirements from design through procurement, installation and operational readiness, and associated required documentation.
- Create, review, and approve out-of-specification (OOS) and out-of-trend (OOT) investigations, deviations, CAPAs, and Change Controls.
Qualifications: - Bachelor's degree in Chemistry, Biochemistry, Molecular Biology, or related discipline (Master's Degree or PhD is preferred).
- 8+ years of experience in leadership, management, or supervisory roles, preferably within the Gene Therapy/Cell Therapy industry.
- Comprehensive experience with the analytical methods used for raw materials testing.
- Expert-level knowledge of raw material requirements described in global pharmacopeias such as USP, EP, JP, BP, Ph. Eur.
- Working knowledge of cell-based assays, qPCR, HPLC, ELISA, SDS-PAGE, mass spectrometry, and molecular biology techniques.
- Expert-level knowledge of CMC analytical and regulatory requirements.
- Expert-level knowledge of cGMP requirements as they pertain to Quality Control raw material testing.
- Demonstrated experience in departmental budgeting, CAPEX procurement, IQ/OQ, safety, and status reporting to Leadership and Senior Management.
- 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 Leadership and Senior Management.
- Ability to work hours necessary to support production and/or product transfer activities.
Preferred: - Experience starting up, scaling, or managing multiple QC laboratories or testing groups, including release, stability, raw materials, primary packaging, printed materials, and in-process testing.
- Hands-on or leadership experience with analytical instrumentation troubleshooting, laboratory equipment qualification, computerized laboratory systems, and implementation of new technologies or laboratory workflows.
- Experience in high-level interactions with domestic and international Regulatory agencies.
- Experience building, managing, or improving QC raw material programs, GMP testing operations, laboratory readiness activities, or supplier/material qualification processes.
- Experience with laboratory quality systems, including OOS/OOT investigations, deviations, CAPAs, change controls, data integrity expectations, and inspection readiness activities.
- Experience working with external contract laboratories, outsourced testing, supplier quality issues, method alignment, or material specification lifecycle management.
- ASQ certification, Lean/Six Sigma certification, or other relevant quality, laboratory, or operational excellence credential.
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.
Work Environment and Physical Demands This position works in a typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. This is largely a sedentary role; persons holding office positions are generally subject to inside environmental conditions having the lighting, temperature, and noise of an open floor-plan office environment. Regularly operate a computer and other office equipment. Regularly communicate with others in person, over the phone, and electronically. Must be able to move and/or carry objects weighing up to 10 lbs.
We've Got You Covered:
At Forge Biologics, we believe our people deserve to be taken care of - in and out of the workplace. We've built a comprehensive compensation and benefits package designed to help you thrive, grow, and feel valued every step of the way:
Health from day one- Health, dental and vision insurance start your first day - with 90% of premiums covered for you and your family.
Time to recharge- A competitive paid time off plan - because rest fuels innovation.
- 12 weeks of fully paid parental leave so you can focus on family when it matters most.
Rewarding your impact- Annual bonus opportunities for all full-time team members.
- 401(k) with company match to help you plan for the future.
- Special employee discounts, including childcare and dependent care savings.
Your wellness, supported- Onsite fitness facility at The Hearth.
- Mental health counseling and financial planning services through our Employee Assistance Program.
- Employer-paid short and long-term disability coverage to protect your peace of mind.
Fuel for your workday- A fully stocked kitchen with free snacks and beverages - we keep you energized and ready for what's next.
Grow with us- Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.
