Regulatory Affairs Specialist – Biotechnology

Lonza; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading biotechnology firm in Singapore is seeking a Regulatory Affairs Specialist to perform GMP manufacturing operations and maintain high lab standards. The ideal candidate possesses a degree in a relevant field, knowledge of cGMP applications, and excellent interpersonal skills. This role offers a dynamic work environment and opportunities for career growth.

Benefits

Daily company bus service

Fully paid medical insurance

Dynamic working culture

Qualifications

• Knowledge of Biopharmaceutical processing is an added asset.
• Relevant work experience in a similar manufacturing industry or cleanroom environment preferred.
• Knowledge of cGMP applications.

Responsibilities

• Perform GMP manufacturing operations, equipment handling, and troubleshooting.
• Maintain facility and lab standards through sanitization and 6S housekeeping.
• Apply aseptic techniques for material and cell culture handling.
• Operate bioreactors, monitoring pH/DO, CO2/O2, and cell performance.
• Execute chromatography, ultrafiltration, and pH/conductivity adjustments.

Skills

Team-oriented demeanor

Strong communication skills

Interpersonal skills

Education

Degree or diploma in a related Science/Engineering field

Tools

UNICORN

DeltaV

Job description

Regulatory Affairs Specialist – Biotechnology

Today, Lonza is a global leader in life sciences operating across five 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.

As a Biotechnologist at Lonza Mammalian business, you’ll be part of our globally recognized network, driving the production of mammalian cell culture and treatments.

Join our best-in‑class high performance Integrated Biologics team at our Tuas site in Singapore to gain unparalleled exposure to cutting‑edge biotechnology and innovation and make a difference from day one. Learn new skills and capabilities. Grow your career with us in manufacturing therapeutic proteins under cGMP conditions. Find out more about what a life at Lonza in Singapore could look like for you by watching this short video.

What you’ll get:

An agile career and dynamic working culture.

An inclusive and ethical workplace.

Compensation programs that recognize high performance.

Daily company bus from the MRT location near your home to and from the Tuas site.

Fully paid medical insurance, with the option to enroll family members at partially subsidized premiums.

The full list of our global benefits can be also found on https://www.lonza.com/careers/benefits.

What you’ll do:

Perform GMP manufacturing operations, equipment handling, and troubleshooting.

Maintain facility and lab standards through sanitization and 6S housekeeping.

Apply aseptic techniques for material and cell culture handling.

Operate bioreactors, monitoring pH/DO, CO2/O2, and cell performance.

Execute chromatography, ultrafiltration, and pH/conductivity adjustments.

Utilize process control systems (UNICORN, DeltaV) and documentation (SOPs, logbooks, BRs).

Handle single‑use technologies and sample submissions via LIMS.

Prepare customer‑specific solutions and set up equipment for operations (CIPs, buffer transfer).

Plan and execute CIPs (downstream), ensuring correct pathways and configurations.

What we’re looking for:

Degree or diploma in a related Science/Engineering field.

Knowledge of Biopharmaceutical processing is an added asset.

Relevant work experience in a similar manufacturing industry or cleanroom environment preferred.

Knowledge of cGMP applications.

Positive team oriented demeanor.

Strong communication and interpersonal skills.

Willing to perform a rotating 12‑hour shift pattern.