Lead Chemist, PAT (Process Analytical Technology)

Job Description

• 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 be the most trusted supplier of bio- pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.

Our Engineers support internal and external manufacturing operations 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 (Process Analytical technology) 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 method 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 tool set to include at line analysis, for e.g., 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 able to design PAT related experiments with limited guidance to efficiently gain results.
• Has an understanding of the pertinent regulatory guidance applicable to PAT. Lead contributions to regulatory filings and internal scientific as well as internal quality/GMP documents regarding PAT. Act as primary lead of regulatory inspections of PAT installations for the site.
• Supports routine supply manufacture by providing on going 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’s.
• Leads collaboration and sharing the best practices with internal/external SMEs (eg CPDC, PCT, ADC, CMSE and other groups within the GSTC network) so as to build PAT and analytical capabilities for PTO.
• Complies with all divisional and site-specific policies, guidelines, and procedures. Making safety adherence as 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.
• Demonstrate leadership behaviour in alignment with the company’s Leadership standards.
• Practice 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 related technical field, including Chemical or Mechanical Engineering, Chemistry or Pharmaceutical Sciences
• Minimum 4 years technical experience in pharmaceutical manufacturing industry
• Expert knowledge of core technology/unit operations relevant to active pharmaceutical ingredients, Biotech and/or Non-Sterile drug product manufacturing.

Current Employees apply

Current Contingent Workers apply

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