Senior Manufacturing Associate II (Principal Biotechnologist) – Large-Scale Allogeneic Cell Therapy

Location: Portsmouth, NH, USA. Onsite, day shift from 7:00 AM to 7:00 PM on a rotational 2-2-3 schedule; weekend shifts include additional shift differential pay.

Company

hirify.global operates a globally connected network of life-sciences manufacturing sites focused on producing medicines and viable therapies for customers.

What you will do

• Lead shop-floor upstream manufacturing operations involving single-use bioreactors, cell growth, culture maintenance, and product harvest.
• Execute aseptic processing in Grade B cleanrooms and batch monitoring in Grade C environments.
• Support facility start-up activities, including engineering runs, training runs, and technical transfer water runs.
• Author, review, execute, troubleshoot, and optimize cGMP documentation, including Electronic Batch Records, SOPs, and Work Instructions.
• Train and mentor manufacturing staff on automated equipment, single-use systems, and facility quality structures.
• Lead minor floor investigations, identify bottlenecks, initiate change controls or CAPAs, and collaborate with supervisors, customer SMEs, and project specialists.

Requirements

• 5–10 years of advanced experience in a cGMP biological or cell therapy manufacturing environment is required.
• Strong knowledge of cleanroom classifications, aseptic processing, and electronic quality documentation platforms such as TrackWise.
• Ability to direct floor activities, troubleshoot technical processing errors under tight timelines, and maintain accountability in a matrixed team.
• High School Diploma or equivalent is required; an Associate’s or Bachelor’s Degree in science or engineering is preferred.
• Ability to stand for extended periods, complete continuous Grade B and Grade C gowning, perform fine-motor manipulations, and occasionally lift up to 50 lbs.

Nice to have

• Specialized upstream processing experience, including bioreactor inoculation, harvest, and single-use systems.
• Associate’s or Bachelor’s Degree in a science or engineering discipline.

Culture & Benefits

• Work in a brand-new large-scale allogeneic manufacturing facility during its launch and production ramp-up.
• Agile, inclusive, ethical, and collaborative working culture centered on accountability, excellence, passion, and integrity.
• Opportunity to serve as a floor lead, mentor junior associates, manage batch progression, and fill in for the shift supervisor.
• Medical, dental, and vision insurance, PTO, and performance-recognition compensation programs.