Operation Principal Scientist, Quality Control

-; Singapore; On-site; SGD 80,000 - 120,000; Full time

Job summary

A leading biopharmaceutical company in Singapore is seeking a Quality Control expert with 10 to 15 years of experience to manage daily QC operations and ensure compliance with GMP standards. The role includes developing QC documentation, supporting the QC management system, and contributing to continuous improvement initiatives. A bachelor's or advanced degree in a related scientific discipline is required, along with strong capabilities in statistical analysis and effective multitasking.

Qualifications

• 10 - 15 years of relevant experience in Quality Control or related field.
• Proficiency with statistical tools for data trending and shelf-life establishment.

Responsibilities

• Support the QC OPS management system in compliance with cGMP expectations.
• Manage daily QC operations and ensure adherence to laboratory safety standards.
• Draft sampling plans and prepare QC documentation.
• Participate in continuous improvement initiatives for QC.

Skills

GMP understanding

Statistical analysis

Multitasking

Time management

Judgment in complex situations

Team collaboration

Education

Bachelor's degree in Biology, Cell Biology, or related field

Job description

Location: Tuas Biomedical Park

Responsibilities

Startup Phase

Participate in establishing the Singapore QC laboratory to meet departmental goals and operational readiness:

1. Method Setup & Readiness Support feasibility assessments, method optimization, and method transfer activities in collaboration with the OPS lead.
2. Equipment & Computer System Setup Assist with user configuration, system testing, and SOP creation for QC instruments together with the OPS lead.
3. Materials Strategy Preparation Draft procedures related to material handling and ensure readiness for sample receipt and processing, working with the OPS lead.
4. Documentation Development Support controlled document creation, management, and versioning in alignment with quality system requirements in partnership with the OPS lead.
5. Training Job Codes / Modules Setup Develop training job codes, competency matrices, and draft OJT materials for QC analysts jointly with the OPS lead.

Routine GMP Phase

1. Support and execute the QC OPS management system in compliance with cGMP expectations.
2. Manage daily QC operations to ensure adherence to GMP, data integrity, data reliability, and laboratory safety standards.
3. Draft sampling plans and stability study protocols.
4. Prepare QC documentation such as departmental procedures, quality standards, analytical method SOPs, and submission-related materials; review QC-related documents from other departments.
5. Contribute to drafting OPS management procedures and analytical method updates; participate in LIRs, OOS investigations, and review change controls or deviations involving QC.
6. Provide laboratory expertise during investigations of production deviations and support problem-solving for issues arising during technology transfers or routine production.
7. Represent QC in training-related initiatives, discussions, or workshops (with QA) and support timely execution of GMP trainings.
8. Ensure that QC personnel are regularly trained on DI, GDP, and GMP policies and regulatory expectations.
9. Oversee inventory of laboratory reagents, consumables, and test solutions to ensure adequate stock levels and avoid testing delays.
10. Participate in QC project management activities as Functional Sponsor (FS) or Functional Leader (FL); support QC FLs by advising on risks, challenges, and issue resolution.
11. Draft applicable CMC sections for regulatory submissions (e.g., INDs, BLAs) and review project-related IPT, IPC, and testing protocols.
12. Participate in continuous improvement initiatives for the QC system and support integration of WBS (WuXi Business System) concepts into daily QC operations (e.g., GEMBA management, Tier 1 board reviews, SOP reviews/approvals, system functionalities for LIMS/ELN/SAP, and compliance support).
13. Travel to other WuXi Biologics sites as needed to support cross-site alignment, resolve workflow challenges, and promote collaboration with partner organizations.
14. Participate in client audits, regulatory inspections, and internal/external audits; ensure QC departmental compliance performance meets QA Quality Council and Quality Management Review requirements.
15. Support departmental budget planning and execution for CAPEX and OPEX in alignment with corporate cost-control policies.
16. Perform other duties as assigned by the supervisor.

Requirements

Education

• Bachelor's, or advanced degree (e.g., Master's/PhD) in Biology, Cell Biology, or a closely related scientific discipline.

Experience

• 10 - 15 years of relevant experience in Quality Control or a related field, with depth of experience commensurate with level of education and demonstrated competency.

Additional Requirements

1. Strong understanding of GMP expectations and familiarity with biopharmaceutical manufacturing and QC testing workflows.
2. Experience in designing or supporting ICH-based stability studies for therapeutic proteins.
3. Proficiency with statistical tools used for stability data trending, interpretation, and establishing shelf-life or expiry based on regulatory guidance.
4. Strong multitasking capability and effective time-management skills.
5. Ability to exercise sound judgment in complex or ambiguous situations.
6. Demonstrated ability to work effectively both independently and in a collaborative team setting.