About The Role: Scientist II, Quality Control: This role combines hands-on analytical testing with leadership and oversight of QC staff. This position will ensure that testing is performed according to cGMP, regulatory requirements, and internal SOPs, while also fostering team development, managing daily workflows, and supporting continuous improvement. This role will also be responsible for advancing method development, validation, and troubleshooting efforts for gene therapy products.
Responsibilities: Scientist II Responsibilities: - Perform in process, release, and stability testing for our most advanced AAV-based (viral vector) therapeutic candidates generated from PD, research, and GMP laboratories.
- Lead and perform advanced analytical testing quality control assays, including qPCR, ELISA, SDS-PAGE, Western blot, and HPLC, to assess the quality, potency, and safety of AAV vector products.
- Supports internal process transfer activities and serves as Subject Matter Expert (SME) to troubleshoot processes/assay.
- 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 and/or reviewing QC reports, SOPs, QC protocols, comparability protocols and reports, and justification of specifications.
- 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 and final product testing controls, including, but not limited to, Standard Operating Procedures (SOPs), Specifications, and Analytical Test Methods.
- Drive the development, optimization, and validation of novel analytical methods to enhance quality control processes.
- Compile data with minimal oversight, generating reports, and archiving assay data; responsible for performing the analysis and interpretation of assay results.
- Draft and revise process documents, assay methods, and sampling plans.
- Support regulatory and client inspections and support internal audits of GMP systems as an SME.
Manager Responsibilities: - Provide technical guidance and mentorship to direct reports and junior team members, promoting their personal growth and skill development.
- Assist/drive 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.
- Responsible for performance appraisals and pay reviews of direct reports. Make decisions based on assigned objectives, as well as company policies and procedures.
- Participate in hiring process as assigned.
- Communicate updates proactively to Quality Control management and direct reports as needed.
- Perform review and approval (where appropriate) of laboratory data, methods, forms and investigations.
- Ensuring training for direct reports is driven to completion to support laboratory needs.
Qualifications: - Bachelor's (or international equivalent) and/or 6+ years of relevant experience, Master's, or PhD or in a relevant scientific field (e.g., biology, biochemistry, molecular biology) with demonstrated leadership skills.
- Advanced knowledge of complex molecular biology, biochemistry, or cell biology techniques and analytical methods (e.g., qPCR, ELISA).
- Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.
- 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.
Preferred Skills: - SME in at least one of the following: Cell, Protein, or Nucleic Acid based assays.
- Effective communication with both management and direct reports.
- Prefer experience with software programs, including, but not limited to: Microsoft software , Veeva, ADP.
- Demonstrated ability to problem solve.
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 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.
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.
