Lead Chemist Job

• Responsible for planning, scheduling and performing laboratory testing of raw materials, packaging components, excipients, in-process control samples, intermediates, semi-finished products, final drug substances and finished products manufactured in API West, Biotech, Pharm West and Pharm South Facilities.


• Responsible for ensuring the analytical methods / specifications used are in accordance with requirements specified in MSD Quality Standards, regulatory dossiers and pharmacopoeia.


• Manage the calibration, maintenance and qualification of laboratory equipment.


• Conduct laboratory investigation on laboratory equipment failure, OOT and OOS.


• Responsible for testing of developmental and clinical products as required.


• Participate in analytical developmental activities as required.

Other responsibilities include: 

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  Perform analytical testing on incoming raw materials, packaging components and excipients.


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  Carry out testing activities associated with release and stability testing of the in-process control samples, intermediates, semi-finished products, final drug substances & finished products.


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  Ensure tests assigned are performed in a timely manner in compliance to Standard Operating procedures with necessary laboratory safety precautions.


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  Carry out cleaning sample testing related to any equipment or facility cleaning activities.


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  Co-ordinate with respective IPT facilities on the timing of drug substances change-over.


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  Perform second person verification of other analysts’ work.


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  Liaise and coordinate with external service providers in carrying out calibration/maintenance of lab equipment and tools when necessary.


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  Carry out lab equipment calibration and proper documentation of all instruments in laboratories.


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  Closely work with supervisor on the requirements of swabbing samples and to identify the appropriate sampling location and take swab samples for testing.


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  Participate in analytical method transfer / validation and equipment Qualifications when necessary.


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  Perform periodic reviews of existing cleaning method validation package & procedure, and to implement corrective actions for the periodic reviews.


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  Assist in writing protocol to support method transfer/validation, compendial method verification and equipment qualifications when necessary.


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  Conduct in Laboratory investigation using 5 whys & fishbone to identify the root cause and its report writing. Ensure laboratory related actions are effectively implemented within agreed time frame, to continually improve processes, prevent waste, and eliminate rework.


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  Provides inputs to new Quality Standards and Standard Analytical Tests; implementing new Quality Standards once approved and obsoleting previous revisions


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  Revise and write Standard Operating Procedures (SOPs) to reflect the current practice and ensuring that the current level of standard are met.


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  Oversee Annual Product Review to ensure that the activities are completed by the required timelines


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  Perform and maintain an acceptable level of good laboratory housekeeping.


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  Maintain inventory and control in-house stock, reference standards, chemical reagents, and consumables and ensure that there are sufficient stocks for testing.


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  Identify and execute laboratory efficiency improvement tasks, e.g., Kaizen.


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  Facilitate training of new recruits and generate the necessary training records and Analyst Qualification and Re-qualification Form (AQRF) for the trainee.


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  Revise and write Standard Operating Procedures (SOPs) to reflect the current practice and ensuring that the current level of standard are met.


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  Assist in responding to queries raised by regulatory agencies pertaining to analytical standards and methods.


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  Assist in periodic review of laboratory procedures and ensure that current practices and standards are incorporated and reflected in the procedures.


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  Responsible for release of batch results


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  Supports Laboratory related metrics analysis and reporting


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  Ensure all staff are appropriately trained and qualified to execute the duties assigned to them with respect to job, cGMP, GLP and SHE expectations as defined in the training matrix


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  Schedule periodic review of test procedure to ensure the test methods and specifications are in line with current requirement specified in MSD Quality Standards, regulatory dossiers and pharmacopoeia.


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  Work closely with global compendial group in reviewing of compendial changes and revise site test procedure and specification if necessary.


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  Review of all the tests datasheet / worksheet records to ensure that the testing results are within SPC limits and meet Product Specification.


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  Participate in SHE, Business Compliance, cGMP and all other compliance-related matters, where applicable.


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  Schedules routine testing and liaises within IPTs organization for priority testing and resource planning for testing I other activities pertaining to laboratory functions.


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  Executes technical laboratory investigations and analyze any analytical failures. Ensure timely closure to committed corrective actions.


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  Assists laboratory manager in day to day laboratory operation to ensure all business and compliance requirements are met.


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  Acts as back-up to lab manager and participates in daily tier 2 walkthroughs.


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  Performs special projects or activities to support IPTs and department objectives such as new production introduction, method transfer and method validation.


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  Leads in executing continuous improvement projects (A3 project) to improve Laboratory efficiency and cost savings.


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  Provides support to other lab function when necessary.
  

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  Bachelor Degree in Chemistry/ Biochemistry.


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  Prior working experience is preferred.


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  Minimum 7 years of experience in pharmaceutical analysis is preferred.


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  Demonstrable experience and competency in Particle size analyzer, GC, HPLC, Karl Fischer Titrator, spectroscopic and wet chemistry testing is preferred.


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  Demonstrated knowledge and application of Lean Six Sigma methodology and tools.


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  Demonstrated knowledge and application of sound scientific principles, theories, techniques and skills.


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  Technical competency in analytical troubleshooting.


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  Demonstrated knowledge and understanding of cGMP, GLP, and associated regulatory expectations related to Pharmaceutical Analytical Testing and Release.


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  Potential to teach and coach the team on technical and business process elements of analytical testing.


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  High level of independence with day to day staff leadership, performance management and development.