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Date: Nov 11, 2017

Location: Singapore, SG

Company: MSD

Requisition ID: PRO016269

The GTO Senior Chemist
supports the Lead Engineer/Chemist in introducing new products to the site, providing
technical expertise on the
manufacture of all drug products on site and transferring drug products to
other facilities.  In collaboration with
supporting functional groups, the GTO Sr Chemist provides technical guidance on
deviations, investigations and customer complaints.  The GTO Sr. Chemist supports continuous
process improvement activities to enhance site performance metrics and
contributes to global technical networks to share site experiences and expand
on personal and site expertise.



 


  • Supports new product introductions to the site by assisting with process
    and equipment comparisons, new raw material introduction, development studies,
    cleaning processes development and validation and process fit and gap analysis.
  • Supports filing activities by
    assisting with process qualification activities, equipment qualification and cleaning
    validation. Expected to have a working knowledge of QMS chapter 13, 17, 25 and
    35 and understands the principles of Quality by Design (QbD) and executes the
    requirements in support of a QbD filing  
  • 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. Responds
    to shifts and trends in performance appropriately and based on the data
    identifies opportunities for improvement.
  • The GTO Sr. Chemist is the change owner for process Global Change
    Management (GCM) change controls.
  • Provides technical expertise related to Process Chemistry in
    manufacturing/cleaning processes in response to deviations to understand and
    eliminate the root cause(s).  Performs
    lab front runs and analytical testing to provide supporting data related to
    equipment and manufacturing/cleaning processes in response to deviations to
    understand and eliminate the root cause(s). 
  • Supports and/or leads investigations for non-emergency product
    complaints and deviations using problem solving tools such as KT. Ishikawa,
    FMEA, 5 Whys.
  • Actively participates and show commitment to collaboration and sharing
    of best practices with internal/external subject matter experts (SMEs) (e.g. CPDC,
    PCT, Sterile council, ADC, CMSE and other groups within the GSTC network.
  • Complies with all divisional and site-specific policies, guidelines and procedures.
    Making safety adherence as a pre-requisite to employment.
  • Demonstrates and promotes safety, health & environment (EHS)
    leadership behaviour, ensuring that all activities are carried out in
    accordance with EHS requirements. Actively participates in GEMBA safety walk, GPC
    lab safety and housekeeping activities, HazOp. 
    Participates in CAPA activities from lab safety inspections and audits.
    Speak on process and laboratory safety and lead by example GPC safety
    commitments.
  • Where applicable, develops SOPs,
    gap analysis and Job Aids for GTO Subsystems in compliance with divisional and
    corporate policies and guidelines
  • Where applicable, maintains GTO
    lab equipments as equipment owners and GTO labs as lab owners.  Develops documentation for GTO lab
    equipments, troubleshoot equipment issues and follow up on required PM for the
    equipments.  Provides training for use of
    lab equipments for GTO chemist/Engineer.
  • Demonstrate leadership behavior in alignment with Merck leadership standards
    (Individual Contributor)
  • Practice Inclusion as the How and Merck Production Systems (MPS)
  • Leads personal career development with manager assistance using MyCareer
    (Development Plan, Self Assessment).
  • Conducts all activities in
    compliance with site and divisional policies, guidelines and procedures and
    within the defined safety requirements
  • Solves a range of problems with
    moderate level of guidance and direction. Expected to be involved in higher
    impact and more complex issue. Expected to understand cost, delivery and supply
    chain impacts
  • Any other duties as assigned by the Supervisor.



Qualifications

Qualification:


Bachelors,
Masters or Ph.D. degree in a technical field, including Chemical or Mechanical
Engineering, Chemistry or Pharmaceutical Sciences



 


Experience:


Minimum
2 years technical experience in pharmaceutical manufacturing industry





Job: Process Engineering
Other Locations:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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