Lead GMP Technician, Downstream

Forge Biologics•Columbus, OH

8d•Onsite

About The Position

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. 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.

Requirements

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)

Nice To Haves

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

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.

Benefits

Health, dental and vision insurance start your first day – with 90% of premiums covered for you and your family.
A competitive paid time off plan
12 weeks of fully paid parental leave
Annual bonus opportunities for all full-time team members.
401(k) with company match
Special employee discounts, including childcare and dependent care savings.
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
A fully stocked kitchen with free snacks and beverages
Ongoing professional development resources, training, and mentorship programs