Lead GMP Technician, Downstream

About the role

We are currently seeking a Lead, GMP Manufacturing - Downstream to join the Forge Biologics team. This is an exciting opportunity to provide active leadership and execution of the Standard Operating Procedures and Master Production Records for downstream manufacturing processes within Forge’s state-of-the-art cleanroom facility.

Responsibilities

• Lead downstream operations for the purification of viral-based vectors related to gene therapy GMP in a cleanroom environment.
• Planning and managing for downstream activities, process optimization, and technology transfer to cGMP for viral vectors.
• Demonstrate proficiency on the specific equipment associated with downstream processes, such as column packing/testing, TFF, and Affinity/Anion Exchange Chromatography.
• Complete and review documentation concurrently with completion of manufacturing processes.
• Collaborate with MS&T to support internal process transfer activities from Process Development to GMP.
• Compile data with minimal oversight to author reports and analyze results for client facing summaries.
• Collaborate with Quality Systems, including QA and QC, to work toward efforts that satisfy GMP regulations and guidances.
• Train and mentor junior technicians; perform periodic review of direct reports.
• Reporting unexpected issues by initiating deviations, participating in investigation, determining root-cause, and implementing CAPA.
• Partner with the Technical Writing team to draft, revise, and review GMP documentation.

Qualifications

• 4+ years of relevant experience in downstream GMP manufacturing, with additional preference for relevant BS or MS degrees.
• Demonstrated experience in downstream techniques, including column packing/testing, tangential flow filtration (TFF), and affinity/anion exchange chromatography.
• Proficiency in purification processes, such as chromatography, filtration, and centrifugation, with a proven ability to operate and troubleshoot equipment in downstream GMP manufacturing environments.
• Working knowledge of cGMP requirements and biological drug development.
• Must be self-motivated, organized, and proactive.
• Able to work the hours necessary to support production and/or product transfer activities.
• Able to work in loud noise environments and in Personal Protective Equipment (PPE).

Preferred Skills

• Working knowledge of aseptic techniques and automated systems.
• Experience with gene therapy manufacturing and proficiency in using single-use technologies within a GMP downstream processing environment.