Senior Manufacturing Associate (Senior Biotechnologist) - Night Shift

About the role

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.

Responsibilities

• 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.

Qualifications

High School Diploma or equivalent is required; an Associate’s or Bachelor’s Degree in a science or engineering discipline is preferred.

Skills

• Strong working knowledge of cleanroom classifications, aseptic processing techniques, and electronic quality documentation platforms (such as TrackWise).
• 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.

Benefits

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

Pay

Nights and weekend shifts include additional shift differential pay.

Schedule

Night Shift, 7:00 PM – 7:00 AM, Rotational 2-2-3 Pattern.