Scientist II, QC Analytical (2nd Shift)

About the role

Forge Biologics, a leader in enabling access to life-changing gene therapies, seeks a Scientist II, Quality Control to join our dynamic team. This role combines hands-on analytical testing with leadership and oversight of QC staff, ensuring compliance with cGMP and regulatory requirements.

Responsibilities

• Perform in process, release, and stability testing for advanced AAV-based therapeutic candidates.
• Lead and perform advanced analytical testing quality control assays, including qPCR, ELISA, SDS-PAGE, Western blot, and HPLC.
• Support internal process transfer activities and serve as Subject Matter Expert (SME) to troubleshoot processes/assays.
• Ensure the effective transfer of analytical methods to Quality Control in a phase-appropriate fashion.
• Contribute to authoring and/or reviewing QC reports, SOPs, QC protocols, comparability protocols and reports, and justification of specifications.
• Conduct thorough investigations to determine root cause of OOS investigations and other non-conforming results and implement appropriate corrective and preventative actions.
• 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.
• 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.

Qualifications

• Bachelor's (or international equivalent) and/or 6+ years of relevant experience, Master's, or PhD in a relevant scientific field (e.g., biology, biochemistry, molecular biology).
• 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.
• Prominent analytical and data interpretation skills to assess and drive quality improvement through the analysis of quality metrics and performance data.
• Rigorous 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.
• Ability to multi-task.
• 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.