Section Lead , QC

Singapore, Tuas Singapore

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.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

Due to business growth in the Cell & Gene Therapy manufacturing, we are recruiting a QC Technical Expert. The role will act as a key team member of the Quality Control Environmental Monitoring department to support Manufacturing operations in areas of routine monitoring of the production environment as well as dynamic monitoring of critical operations. The Technical Expert will also provide on-time, high quality results to meet Manufacturing needs.

Key responsibilities:

  • Supervising the review of laboratory data (both internal and external) and the closeout of deviations

  • Author and review Change Controls, Deviations/Investigation as well as Test Methods, Specifications and SOPs

  • Perform report writing (Example: Deviations/Investigations/Trending)

  • Maintains knowledge of new technologies

  • Strong ability to manage multiple priorities and lead projects.

  • Source of expertise for rest of staff

  • Customer and regulatory agency interaction as required

  • Problem solving of analytical/ microbiological methods as well as troubleshooting of equipment as applicable

  • Manage/perform equipment qualification and validation maintenance review

  • Lead/ execute method transfers and validation/ qualification

  • In addition the technical contributions above, Section Leads and Senior Section Leads are expected to manage associates

  • Any other duties as assigned by your Manager

Key requirements:

  • Degree/Diploma in a relevant Science field or Equivalent

  • Extensive experience in Cell Count and Viability, Flow Cytometry (i.e. FACS), QPCR, ELISA, bioburden testing and endotoxin testing.

  • Understands the theory and practical aspects of method and equipment qualification

  • Strong ability to work and influence across different functional teams

  • Highly motivated and ability to work under challenging timelines

  • Excellent technical writing skills

  • Able to communicate effectively in professional manner with customers

  • Relevant experience and accomplishment to dictate final position for which the candidate may qualify

  • Well versed in cGMP regulations

  • Good problem solving and analytical skills

  • Good communication skills.

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.

Vaccination status: As the above role requires you to work on-site*, only fully vaccinated** employees will be shortlisted for the role.  For fully vaccinated applicants, please indicate your vaccination status as “fully vaccinated” when applying for the role.

*In line with the latest advisory from the Ministry of Manpower, from 1 January 2022 only employees who are fully vaccinated or have recovered from COVID-19 within the past 180 days, can return to the workplace.

** Lonza adopts the definition of “fully vaccinated” by the Ministry of Health in Singapore which means that you:

(a) have received the full regimen of WHO EUL vaccines from a specific manufacturer; and

(b) have met the prescribed post-vaccination period for the respective vaccine to be fully effective.

We provide company transport, both ways, at multiple pick up points.

Reference: R48504