What you'll do:
The Biotechnologist role is responsible for the manufacture of therapeutic cell products under CGMP conditions. Working closely with a team of up to 40 technical, SME and supervisor/manager colleagues, Cell Therapy Biotechnologists are expected to execute CGMP Cell Therapy production activities through to filling of final dose product within a stringent CGMP clean room environment. As a member of the Cell Therapy Manufacturing team the aim of this position is to develop expert technical knowledge and flawless execution of the Cell Therapy production process.
Production activities occur in the classified production suite which requires change into cleanroom clothing and compliance with clean room standards. This includes removal of jewelry/make-up, donning of over suits/coveralls, safety shoes, shoe covers/booties, hair cover, gloves and safety glasses/shield.
This position could be an ideal opportunity for someone with an interest in Cell Therapy production wanting to develop their production career in a different technical/scientific area. Thorough training and continual assessment will be provided. After training successful applicants would be expected to join day, weekend and public holiday rotation shift. (12 hours)
Primary Responsibilities
· Complies with site/department EHS standards (policies, rules and regulations).
· Attains a thorough understanding of the principles of CGMP compliance and clean room practices.
· Contributes to appropriate maintenance of 'in-operation' production facilities and equipment. g. cleaning & sanitization, equipment monitoring, sampling, pH and conductivity checks.
· Solution and medium preparation followed by aseptic filtration into sterile containers.
· Revival and culturing of anchorage dependent cell lines in static flasks and cell factories.
· Harvest and concentration of cell factory generated cell cultures using tangential flow filtration or/and centrifugation.
· Final formulation and filling of vials. Visual inspection and cryopreservation.
· Participation in aseptic process simulations.
· Accurate and thorough completion of batch record documentation.
· Environmental monitoring (viable particulates, nori-viable particulates, surface and operator).
· Formulation of media and aseptic filling of media bags and bottles
What we're looking for:
· Degree/ Diploma/ NITEC in a related Science/ Engineering discipline
· Individual without prior working experience in the biopharmaceutical manufacturing industry is encouraged to apply as training will be provided
· Knowledge of cGMP applications
· Knowledge of cell culture and the principles of aseptic processing within a classified environment.
· Strong team oriented work ethic
· Positive team oriented attitude
· Strong communication and interpersonal skills
· Willing to perform rotating 12-hour shift pattern
· Able to perform physical activities in a clean room environment. Individual will be on the feet most of the time, and will be required to perform manual work (> 60% of activities) in a buddy system that includes standing, carrying items that weigh up to 12 kg, or moving equipment.
About Lonza
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.