Upstream Process Lead: Assume the shop-floor lead role during core upstream manufacturing operations, specifically managing single-use bioreactor systems, cell growth, culture maintenance, and product harvest activities.
Hybrid Gowning Execution: Comfortably balance processing environments by dedicating approximately 25% of your time to Grade B gowning, executing critical, high-stakes aseptic processing techniques to start the campaign, while spending the remaining 75% of operations in a Grade C cleanroom setting.
Facility Launch Support: Provide hands-on operational support during the facility's initial engineering runs, training runs, and technical transfer water runs scheduled to kick off this July.
Documentation & EBR Optimization: Author, review, and execute critical cGMP documentation, with a strong focus on generating, troubleshooting, and optimizing Electronic Batch Records (EBR), Standard Operating Procedures (SOPs), and Work Instructions (WIs).
Staff Training & Mentorship: Arrange, coordinate, and deliver effective hands-on training to manufacturing staff regarding new large-scale automated equipment, single-use single systems, and facility quality structures.
Quality & Deviation Ownership: Maintain absolute adherence to cGMP and Data Integrity policies, leading minor floor investigations, identifying process bottlenecks, and initiating change controls or CAPAs.
Cross-Functional Collaboration: Partner with the shift supervisor, customer SMEs, and Manufacturing Project Specialists to introduce operational improvements and track production milestones effectively.
Requirements
Experience: 5-10 years of advanced experience within a cGMP biological or cell therapy manufacturing environment is required. Prior specialized experience in upstream processing (bioreactor inoculation, harvest, single-use systems) is a highly desired plus but not explicitly required.
Technical Mastery: Strong working knowledge of cleanroom classifications, aseptic processing techniques, and electronic quality documentation platforms (such as TrackWise).
Leadership Traits: Proven ability to direct day-to-day work tasks on the floor, troubleshoot technical processing errors under tight timelines, and maintain high standards of accountability within a matrixed team.
Education: High School Diploma or equivalent is required; an Associate's or Bachelor's Degree in a science or engineering discipline is preferred.
Physical Requirements: Ability to comfortably stand for extended periods, undergo continuous sterile gowning protocols (Grade B and Grade C), perform precise fine-motor manipulations, and occasionally lift up to 50 lbs.
Benefits
Dental insuranceVision insurancePaid time off
Additional Information
Senior Manufacturing Associate (Senior Biotechnologist) - Large Scale Allogeneic Cell Therapy
Location: Portsmouth, NH, USA.
Schedule: Night Shift, 7:00 PM - 7:00 AM, Rotational 2-2-3 Pattern (B Days/B Shift Rotation). Nights and weekend shifts include additional shift differential pay.
Operational Timeline Note: This role supports our brand-new, state-of-the-art Large Scale Allogeneic manufacturing facility. The team is currently gearing up to launch initial facility water runs in July, with routine clinical and commercial production ramping up shortly thereafter. Depending on when the candidate starts, they may initially work a standard day shift for a brief onboarding and training period before transitioning permanently to the night shift, based on production timelines.
We are seeking a highly skilled technical leader to join our team in Portsmouth, NH, as a Senior Manufacturing Associate (Senior Biotechnologist) . This advanced, floor-based role is responsible for acting as a shop-floor Subject Matter Expert (SME) and leadership anchor during the critical start-up and scaling phases of our brand-new Large Scale Allogeneic asset. Operating under general supervision, you will lead complex, automated unit operations, spearhead operational readiness activities, and manage technical workflows across distinct cleanroom zones. This is an upstream-focused manufacturing role utilizing single-use bioreactor technologies.
What will you get?
An agile career and dynamic working culture
An inclusive and ethical workplace
Brand-New Facility Launch: Play a vital role in the history of the site by driving the very first water runs and production campaigns of a brand-new, large-scale asset.
Hybrid Cleanroom Exposure: Gain an optimal operational balance, executing high-stakes aseptic setups in Grade B spaces before transitioning to long-term batch monitoring in Grade C environments.
Floor Leadership Path: Serve as a designated floor lead, mentoring junior associates, managing batch progression, and acting as a primary fill-in for the shift supervisor when necessary.
Compensation programs that recognize high performance
Medical, dental and vision insurance, as well as PTO and more
Our full list of global benefits can be found here: https://www.lonza.com/careers/benefits .
Lonza · Us - Portsmouth, NH