Lead Chemist, PAT (Process Analytical Technology)

• Based in Singapore, the regional hub for Asia Pacific (AP) and top-ranked biopharmaceutical company on the Straits Times and Statista’s list of Best Employers in Singapore for two consecutive years (2020, 2021).
• Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years.

Our Manufacturing & Supply Division is committed to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that is committed to delivering high-quality, reliable supply to customers and patients on time, every time.

Our Engineers support internal and external manufacturing operations to remain operational, continuously improve, and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation.

The Lead Chemist, PAT (Process Analytical Technology) role provides drug substance and/or drug product PAT development and testing support for all manufacturing processes manufactured on-site, including providing technical expertise in the area of PAT to support manufacturing activities on-site and transferring of manufacturing activities to other facilities. The Lead Chemist PAT demonstrates advanced skills in developing PAT methods and validating methods, implementation strategy, and supports investigations involving PAT, as well as providing PAT solutions for process robustness issues and process-related investigations for manufacturing processes on-site. The Lead Chemist PAT performs all activities in compliance with all regulations, policies, and procedures on-site.

Main Responsibilities

• Leads the development and implementation of advanced in-line, on-line, and at-line PAT methods for the assessment of chemical and physical product and process parameters. The scope of the contributions includes methods to support development of design spaces on new products, support of technology transfer as well as methods for control either in-process and real-time testing (RTRT) applications including new and established products.
• Utilizes technologies that include but are not limited to spectroscopic techniques, PAT-adapted analytical technology such as online HPLC, online MS, Raman, FTIR Spectroscopy as well as multivariate modelling of process data, as well as further expanding on the PAT toolset to include at-line analysis, for example, conductivity, pH, refractive index, etc.
• Leads and advises others on experimental design and execution, statistical analysis, analytical method development, and validation.
• As a subject matter expert in PAT, both theory and practice, provides PAT solutions and technical expertise to support site process robustness issues and process-related investigations. Is able to independently problem-solve challenging PAT and analytical issues and design PAT-related experiments with limited guidance to efficiently gain results.
• Has an understanding of the pertinent regulatory guidance applicable to PAT. Leads contributions to regulatory filings and internal scientific as well as internal quality/GMP documents regarding PAT. Acts as primary lead of regulatory inspections of PAT installations for the site.
• Supports routine supply manufacture by providing ongoing PAT technical support to the IPT and proactively monitoring the performance of equipment module(s) or unit operation(s) during manufacturing and cleaning using PAT. Proposes and implements new PAT solutions to support manufacturing, understand shifts and trends, and process robustness issues.
• Provides training and coaches/mentors the PTO Engineers/Chemists in PAT-related equipment.
• Leads collaboration and sharing of best practices with internal/external SMEs (e.g., CPDC, PCT, ADC, CMSE, and other groups within the GSTC network) to build PAT and analytical capabilities for PTO.
• Complies with all divisional and site-specific policies, guidelines, and procedures, making safety adherence a prerequisite to employment. Demonstrates and promotes safety, health & environment (EHS) leadership behaviors, ensuring that all activities are carried out in accordance with EHS requirements.
• Where applicable, develops and reviews SOPs, gap analysis, and Job Aids for PAT within PTO Subsystems in compliance with divisional and corporate policies and guidelines.
• Demonstrates leadership behavior in alignment with the company’s Leadership standards.
• Practices inclusion as the How and Production Systems (MPS).
• Leads personal career development with manager assistance using myCareer and career mapping (development plan, self-assessment).
• Any other duties as assigned by the Supervisor.

Qualifications

• Bachelor, Master, or PhD in a related technical field, including Chemical or Mechanical Engineering, Chemistry, or Pharmaceutical Sciences.
• Minimum 4 years technical experience in the pharmaceutical manufacturing industry.
• Expert knowledge of core technology/unit operations relevant to active pharmaceutical ingredients, Biotech, and/or Non-Sterile drug product manufacturing.