Senior Biotechnologist (Nights - Cell Therapy)

Lonza•Portsmouth, NH

3d•Onsite

About The Position

We are seeking a highly skilled and experienced professional to join our team in Portsmouth, NH, as a Senior Biotechnologist. This advanced, high-impact role is responsible for acting as the shop-floor Subject Matter Expert (SME) and leadership anchor during night shift cell therapy production campaigns. The ideal candidate will possess advanced technical knowledge of aseptic operations, lead complex processing runs, and play a pivotal role in operational readiness and customer tech transfer activities under general supervision.

Requirements

5–10 years of advanced manufacturing experience in biological and/or Cell Therapy processing.
Proven experience working in classified cleanroom settings with automated processing systems is required.
Expert knowledge of biological manufacturing operations (such as fermentation, purification, or drug product filling) paired with a deep understanding of electronic batch record (EBR) mapping and manual/automated visual inspection systems.
Demonstrated ability to manage complex initiatives simultaneously, provide real-time coaching via shop-floor GEMBAs, and effectively fill in for the Manufacturing Supervisor in their absence.
High School Diploma or equivalent is required.
High level of agility, proactive communication style, and the financial accountability required to track project milestones and manage material requisitions accurately.

Nice To Haves

An Associate’s or Bachelor’s Degree in a science-related discipline is preferred.

Responsibilities

Assume the lead role during complex night-shift unit operations (e.g., cell growth, harvest, vial filling, and visual inspection) and serve as the floor Subject Matter Expert until manufacturing staff are fully proficient.
Provide vital operational input into tech transfer activities—including water runs, training runs, and engineering runs—collaborating directly with customer tech teams and internal stakeholders.
Author, review, and approve critical cGMP documentation such as electronic batch records (EBR), Standard Operating Procedures (SOPs), and Work Instructions (WIs) to ensure optimal clarity and accuracy.
Coordinate suite readiness initiatives, leading the strategic integration of safety, gowning, cleanroom cleaning, environmental monitoring (EM), and scheduling strategies.
Arrange and provide effective hands-on training to manufacturing colleagues regarding new equipment, complex processes, and quality tracking systems.
Partner with the project specialist team and floor supervisors to incorporate process and operational enhancements into new customer campaigns.
Maintain strict compliance with EHS and cGMP guidelines, actively participating in continuous improvement activities and supporting regulatory or customer audits as needed.