Director Analytical Method Development Jobs Near Me

Forge Your Future with Us:

At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from ideas into reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities — all united by one goal: improving lives. If you're driven by purpose and excited to make a tangible impact, this is where your journey begins.

Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio. Here, you won't just watch innovation happen — you'll be part of it. Whether you're scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, you'll play a key role in bringing hope to patients with genetic diseases.

What sets Forge apart is our culture of H.O.P.E. We are hardworking, showing up each day with determination and grit. We are open, creating a space where ideas flow freely, and every voice is valued. We are purpose-driven, with every task directly tied to changing lives. And we are engaged, energized by the challenges we face and the milestones we achieve together.

At Forge, your growth matters. We're committed to helping you expand your skills, take on new challenges, and develop your career through mentorship, hands-on learning, and opportunities for advancement. Our people are our greatest investment, and we're proud to see team members grow with us.

If you're ready to use your talent to help deliver hope to patients around the world, join us — and be part of something bigger than yourself.

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. 

• 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. 

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.