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Associate Specialist, Drug Product Commercialisation, Development & Supply

Posted 3 days 4 hours ago by MSD Malaysia

Permanent
Full Time
Other
Not Specified, Ireland
Job Description

Job Title: Associate Specialist, Drug Product Commercialisation, Development & Supply

Responsibilities
  • Plan, conduct, evaluate and interpret process development studies, including scale up, drug product characterization, and design space development.
  • Process validation.
  • Clinical and formal stability batch manufacture.
  • Lead and participate in cross functional teams to carry out Quality Risk Assessments, Quality Investigations, Safety Assessments and Change Control Process.
  • Problem solving skills essential; knowledge of Quality by Design concepts, risk based approaches to development, design of experiments, and process modelling.
  • Support commercial supply activities: manufacturing and cleaning recipe and documentation preparations; technical support to manufacturing and cleaning campaigns; troubleshooting, investigations and documenting process issues and deviations.
  • Identify and implement process improvement and optimisation opportunities.
  • Other responsibilities include data analysis, technology evaluation, SOP authorship and compliance with applicable safety and current good manufacturing practices.
Qualifications
  • Minimum 1-3 years relevant experience in Oral Solid Dosage Manufacturing.
  • Strong oral communication skills.
  • Proficiency in technical writing.
  • Ability to work independently and deliver work on time.
  • Bachelor's or postgraduate degree in Chemical or Process Engineering or a Science related discipline.
Preferred Skills
  • Oral Solid Dosage, Problem Solving Tools, Process Development (PD).
EEO Statement

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.

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