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Manufacturing Associate Level 2

3 months ago

Newington, United States Lonza Full time
United States, Portsmouth (New Hampshire)

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 Biotechnologist/Manufacturing Associate, Level II, 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. Manufacturing Associate, Level II, will be proficient in an assigned area (i.e. Cell Growth, Drug Product Filling, etc.) and work in a team environment during manufacturing operations (i.e. harvest, fill/finish, visual inspection, etc.).

• Work with customer SMEs to transfer in and maintain customers' processes in production facility.

• Provide/Arrange effective trainings for manufacturing staff related to any new equipment or systems to be used in Cell Therapy.

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

• Collaborate with CT Manufacturing Leadership team to determine equipment and materials the suite will need to purchase in order to run the process.

Key Responsibilities

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

• Set up of manufacturing procedures & collaboration with QA to support CT quality systems aligned with existing and new operations.

• Support building & establishing the manufacturing team by participating in the interview, onboarding and training of new colleagues.

• Support the delivery of clinical & commercial material as required.

• Support the definition and execution of Technical Transfer activities for the CT projects at LPO to include:

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

• Operational support into defining & executing manufacturing activities 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.

• Support the development and execution of appropriate tasks with regard to suite readiness.

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

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;

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

• Prior work experience in a cleanroom, laboratory, other sterile setting is preferred.

• Prior experience with Aseptic Techniques and gowning procedures is preferred.

• Working experience in manufacturing; cGMP setting preferred. Ideal candidate will have experience within Cell and Gene Therapy field.

• Able to follow documentation procedures for day to day tasks in a regulated industry

• Proven logic and decision making abilities, critical thinking skills.

• Strong written and verbal communication skills are required.

• The employee is living the cultural beliefs with the flexibility to adapt to changing business priorities. Is open to and actively seeks out feedback on their performance and translates that feedback into action.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Reference: R61399