Senior Manager/Principal Scientist (Metrology)

WuXi Biologics; Singapore; On-site; SGD 70,000 - 100,000; Full time

Job summary

A biopharmaceutical company located in Singapore is looking for a highly skilled professional to oversee quality control metrology and ensure compliance with laboratory standards. The role requires a Bachelor of Science degree and at least 6 years of relevant experience, with 2 years in management. Ideal candidates will have strong communication skills and experience in a GMP environment, along with expertise in advanced laboratory equipment. This position involves preparing SOPs, providing training, and managing QC processes.

Qualifications

• 6+ years of relevant experience for Bachelor's degree.
• 4+ years of QC experience for Master's degree.
• 2 years of management experience required.

Responsibilities

• Oversee QC metrology qualification processes.
• Act as SME for qualification root cause analysis.
• Prepare SOPs and reports as needed.
• Maintain calibration/maintenance reports.
• Provide training relevant to compliance issues.

Skills

Strong communication skills

Scientific and technical writing

Problem-solving skills

Education

Bachelor of Science or advanced degree in relevant field

Tools

Advanced laboratory equipment (HPLC, CE, PCR)

Job description

Job Responsibility

1. Oversees the implementation and continual improvement of the QC metrology qualification/computer system qualification processes. Advises staff on areas of improvement, QC focus areas and efficiency in the quality control metrology process.
2. Act as on-site SME for metrology or computer system qualification root cause analysis or CAPA.
3. Provides key input and recommendation of data review or investigation process. Serves as lead for client discussions regarding project quality or investigations related to studies.
4. Have some knowledge of microbiological, protein-based assays, including bioburden, endotoxin, HPLC, CE electrophoresis, ELISA, PCR and/or potency methods.
5. Use proficiently advanced laboratory equipment, such as, but not limited to HPLC, CE, PCR, plate readers, etc.
6. Effective multi-tasking skills and time management required.
7. Evaluate technical data and record data accurately and legibly.
8. Able to work with QA in coordination towards adhering and supporting Data Integrity compliance towards work and review.
9. Provide training in the areas of technical expertise and compliance issues relevant to the lab setting.
10. Prepare SOP, protocols, final reports, investigations, and deviations as needed.
11. Conduct timely review of equipment calibration/maintenance reports and data appropriately.
12. Supervise personnel and assume all associated responsibilities.
13. Maintain/review laboratory notebooks and worksheets for QC equipment/software as required.
14. Able to develop/align QC equipment and software systems laboratory SOPs with global corporate standards.
15. Work on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
16. Normally receives minimal instructions on routine work and detailed instructions on new assignments.

Requirement

1. Bachelor of Science degree and/or advanced Graduate degree in Chemistry, Microbiology, Biochemistry or equivalent field.
2. 6+ years of relevant experience or equivalent for Bachelors’
3. 4+ years for Master’s in the Quality Control or related field or equivalent experience.
4. 2 years of Management experience required.

Other requirements (e.g.: working time, special skills)

1. Strong communication skills, both written and verbal, and outstanding interpersonal skills.
2. Strong skills in scientific and technical writing.
3. Good software operation skill, intermediate to advanced level in Microsoft Word, Excel, PowerPoint.
4. Critical thinking, scientific reasoning and problem-solving skills.
5. Experience in quality control laboratory or in a GMP environment.
6. Familiar with Computerized System related regulatory, such as CFR21 Part11, EU GMP Annex 11, etc.
7. Familiar with analytical instrument/equipment qualification, calibration, PM and repair, such as UPLC, HPLC, CE and CIEF etc.
8. Would be a plus if having the following working experiences:
   • 1). Analytical instrument/equipment operation and sample testing.
   • 2). Handling deviations, change control, and responding to audit questions.
   • 3). Operation of instrument software, including but not limited to LES, ELN, Cispro, Empower, SoftMax Pro, EndoScan-V, Lab-X., and LIMS for Lab Admin role.