Lead GMP Technician, Downstream

About The Role:

We are currently seeking a Lead, GMP Manufacturing- Downstreamto 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. The role will manage a team of technicians at various levels who implement and perform downstream operations, interacting with clients to complete projects for viral vector purification methods according to client specifications. The ideal candidate will be skilled in technical problem-solving and laboratory techniques to support our growth in the Gene Therapy sector.

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-motivating, organized, and proactive
• Ability to work the hours necessary to support production and/or product transfer activities
• Ability 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

_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 a 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. Must be able to lift heavy objects up to 50 lbs.

This role requires scheduling flexibility to support GMP manufacturing operations, including the ability to flex hours, work weekends or holidays, and adapt to changing shift assignments based on production demands. Shift schedules may change with limited notice, and work assignments will be determined according to business needs to ensure uninterrupted manufacturing support. The position also requires the ability to complete intermediate mathematical equations, including calculations related to buffer preparation, dilution factors, unit conversions, and process parameter adjustments, performed accurately and consistently in accordance with cGMP expectations.