Lead GMP Technician, Downstream

Forge Biologics•Columbus, OH

7d•Onsite

About The Position

Forge Biologics is seeking a Lead, GMP Manufacturing - Downstream to join their team. This role involves providing active leadership and execution of Standard Operating Procedures and Master Production Records for downstream manufacturing processes within a state-of-the-art cleanroom facility. The position will manage a team of technicians, implement and perform downstream operations, and interact with clients to complete projects for viral vector purification methods according to client specifications. The ideal candidate will possess strong technical problem-solving skills and laboratory techniques to support growth in the Gene Therapy sector. Forge Biologics operates out of The Hearth, a 200,000-square-foot cGMP facility in Columbus, Ohio, focusing on enabling access to life-changing gene therapies.

Requirements

4+ years of relevant experience in downstream GMP manufacturing
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)
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.
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.

Nice To Haves

Relevant BS or MS degrees
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