Cell Therapy Senior Biotechnologist (Manufacturing)

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Check out this video about what a career at our Portsmouth NH facility could look like for you: Your Career with Lonza in Portsmouth, NH (youtube.com)

Shift Schedule: The shift schedule is from either 7am-7pm on a rotating schedule each week:

• Week 1: MON/TUE/FRI/SAT/SUN

• Week 2: WED/THUR

• Shift differentials are included for weekends worked

• 8 Hours of OT built into schedule each week

• Initial 2-week training period on day shift Monday-Friday upon hire for new hires

The Cell Therapy Senior Biotechnologist/Manufacturing Associate will help to provide a safe, controlled work environment in all areas of expertise. Be aware of the site safety objectives and make sure they are communicated and understood. Flexibility to work within the CT network and travel as necessary to support other sites.

Senior Manufacturing Associates will act as the Subject Matter Expert in the assigned area (i.e. Cell Growth, Drug Product Filling, etc.) during manufacturing operations. 

The Senior Manufacturing Associate will assume the lead role during manufacturing operations (i.e. harvest, vial filling, visual inspection, etc.). 

Work with customer SMEs to transfer in and maintain customers' processes in production facility.  Attend technical and project meetings as necessary as the manufacturing representative for processes during campaign preparation. 

Provide/Arrange effective trainings for manufacturing staff related to any new processes, batch records, or quality systems to be used in Cell Therapy . 

Collaborate with CT Manufacturing project specialist team to incorporate process and operational improvements into new customer processes in manufacturing. 

Collaborate with CT Manufacturing team to determine equipment and materials the suite will need to purchase in order to run the process.  May act as fill in for Manufacturing Supervisor.

Key Responsibilities

• Support the definition and execution of Operational Readiness Activities for all Cell Therapy projects at LPO to include:

• Collaboration with cross-functional teams and QA to support CT quality systems and alignment with existing /prospective operations.

• Support building & establishing the manufacturing team which may include interviewing, onboarding and training of new colleagues.

• Delivery of clinical & commercial material milestones and project deliverables as required.

• Support the development and execution of appropriate Safety, Training, Gowning, Material, Visual Inspection, APS, Cleaning, Scheduling, and EM strategies.

• Support the definition and execution of all activity in compliance with EHS requirements.

Support the definition and execution of Technical Transfer activities for CT Projects at LPO to include.

• Potentially assume Tech Transfer Lead role.

• Operational input into material requirements, process execution & procedure transfer.

• Operational input into defining & executing manufacturing activity related to Technical Transfer – water runs, training runs, particle runs, engineering runs etc.

• Enable timely delivery of milestones for the Technical Transfer.

• Author, review, and approve documentation (electronic batch records, SOPs, WIs, and logbooks) for completeness, clarity, accuracy, and submit edits for revision as required.

As project contributor collaborate with CT Manufacturing Leadership Team to ensure.

• Timely tracking of relevant project metrics

• Progression of necessary purchase requisitions/orders and tracking through delivery

• Appropriate interaction with assigned external (customer) and internal stakeholders.

Key Requirements

• High School Diploma or Equivalent minimum; AS/BS preferred;

• Senior Level Biotechnologists require prior experience in Cell and Gene Therapy manufacturing operations.

• Preferred area of study: Science related discipline, degrees in Genetics are relevant.

• Prior work experience in a cleanroom, laboratory, other sterile se