Lead Chemist, API Job

Date: Dec 5, 2018

Location: Singapore, SG

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Requisition ID: PRO018729


  • Leads the method development and implementation of advanced in-line, on-line, and at-line PAT instruments, for eg, NIR, FTIR, pH, online MS for in process and real time release testing in both the active Pharmaceutical Ingredients (API) and secondary manufacturing plants. The scope of the contributions includes using chemometrics and multivariate analysis for development of methods to support online measurements during manufacturing, technology transfer of new PAT technology, instruments and methods for in process and/or real-time release testing (RTRT) applications for new or current supply manufacturing.

  • Has strong knowledge in PAT analytical technologies that include but are not limited to spectroscopic techniques, such as online HPLC, online MS, Raman, NIR spectroscopy, FTIR Spectroscopy, as well as multivariate and univariate modeling of process data and chemometrics.

  • Leads and advises others on experimental design and execution, statistical analysis for PAT analytical method development and validation.

  • As a subject matter expert in PAT, provides PAT solutions and technical expertise for the plant to support site process robustness issues and process related investigations. Is able to independently problem solve challenging technical issues related to PAT failure in the plant and able to design experiments with limited guidance to efficiently gain results. Experiment design includes designing and conducting feasibility studies for using of new PAT instruments for process understanding and data collection and method validation.

  • 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 for PAT. Act as primary lead of regulatory inspections of PAT installations for the site.

  • Supports routine supply manufacture by providing on going technical support to the IPT and proactively monitoring the performance of equipment module(s) or unit operation(s) during manufacturing and cleaning using PAT. Responds to shifts and trends in performance appropriately and based on the data identifies opportunities for improvement.

  • Develops and reviews SOPs, gap analysis and Job Aids for PAT systems in both the lab and the plant as so to be in compliance with divisional and corporate policies and guidelines.
Qualifications


  • Bachelor, Master or PHD in related Sciences, for eg Pharmaceutics/Pharmacy or Chemistry/Chemical Engineering.

  • Candidate with experience in PAT in a manufacturing setting and knowledge in chemometrics, NIR, multivariate analysis and SBOL is an added advantage.

  • Minimum 4 years technical experience in pharmaceutical manufacturing industry. Experience with PAT instruments and knowledge are preferred.

  • Good knowledge of secondary manufacturing/drug product manufacturing are preferred.


Job: Process Engineering
Other Locations:
Employee Status: Regular
Travel:
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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