Senior Specialist, QC (Technical Reviewer)

Reposted 18 Days Ago
Be an Early Applicant
Singapore, SGP
In-Office
Senior level
Pharmaceutical
At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization.
The Role
The Senior Specialist is responsible for leading technical reviews, ensuring compliance, mentoring junior staff, and supporting quality investigations related to assays and technologies in a life sciences environment.
Summary Generated by Built In

 

What you’ll get

  • An agile career and dynamic working culture in a global life sciences leader.

  • An inclusive and ethical workplace that values diversity and integrity.

  • Competitive compensation programs that recognize high performance.

  • Professional growth opportunities through cross-functional projects and global exposure.

  • Comprehensive medical insurance, with the option to enroll family members at partially subsidized premiums.

  • Company transport provided from designated MRT locations to and from the Tuas site.

  • Access to Lonza’s full suite of employee benefits: www.lonza.com/careers/benefits

What you’ll do

  • Perform and/or lead technical review of assays for stability, batch release, evaluation, method transfer, and characterisation studies in accordance with SOPs, protocols, and GMP principles.

  • Independently assess assay validity and make sound technical and quality decisions, including handling complex scenarios in a safe and compliant manner.

  • Interpret analytical data against study specifications, identifying trends, atypical, OOS (Out of Specification), and OOT (Out of Trend) results.

  • Lead and support investigations (e.g. deviations, atypical/OOS/OOT results, CAPAs, change controls, invalid assays), ensuring robust root cause analysis and timely closure.

  • Plan, prioritise, and deliver assigned tasks within required timelines, proactively communicating progress and escalating issues when necessary.

  • Collaborate with operators, study directors, managers, and cross-functional teams to complete technical reviews and ensure quality outcomes.

  • Provide feedback to support development of team members and act as a mentor/trainer to junior staff.

  • Contribute to and lead continuous improvement initiatives, promoting best practices and addressing non-compliant or inefficient processes.

  • Support quality records management, ensuring accurate documentation, reporting, and audit readiness.

  • Participate in project teams and technical discussions, and where required, act as a QC representative in customer interactions.

  • Support regulatory and customer audits by providing technical expertise and ensuring compliance.

  • Assist in the introduction, transfer, and validation of new methods and technologies.

  • Contribute to QC laboratory operations, including housekeeping, equipment monitoring and maintenance, and potential system ownership responsibilities.

  • Support scheduling and coordination of technical reviews as required.

  • Work collaboratively to meet business, regulatory, and customer expectations.

  • Perform other duties as assigned.

What we’re looking for

  • Bachelor’s or master’s degree in biology, Biochemistry, Biotechnology, or related discipline (or equivalent industry experience).

  • Good understanding of protein stability and relevant analytical techniques.

  • Working knowledge of cGMP within a regulated environment.

  • Strong ability to interpret scientific data and make sound quality decisions.

  • Good organisational and time management skills, with the ability to prioritise effectively.

  • Proactive mindset with strong problem-solving skills and attention to quality.

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.

Skills Required

  • Bachelor's or master's degree in biology, Biochemistry, Biotechnology, or related discipline
  • Good understanding of protein stability and relevant analytical techniques
  • Working knowledge of cGMP within a regulated environment
  • Strong ability to interpret scientific data and make sound quality decisions
  • Good organisational and time management skills
  • Proactive mindset with strong problem-solving skills and attention to quality
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The Company
HQ: Basel
0 Employees
Year Founded: 1897

What We Do

At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization. Our community of 16,000 talented employees work across a global network of more than 30 sites to deliver for our customers across the pharma, biotech and nutrition markets.

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