Senior Manufacturing Associate II; Principal Biotechnologist Scale Allogeneic - Day Shift

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

Location: Portsmouth, NH, USA.

Schedule: Day Shift, 7:00 AM - 7:00 PM, Rotational 2-2-3 Pattern. 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.

We are seeking a highly skilled technical leader to join our team in Portsmouth, NH, as a Senior Manufacturing Associate II (Principal 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.

• 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:

• 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 & E  Optimization: Author, review, and execute critical cGMP documentation, with a strong focus on generating, troubleshooting, and optimizing Electronic Batch Records (E ), 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.

• Experience: 5-10 years of advanced experience within a cGMP biological or cell therapy manufacturing environment is…