Job Description

A great opportunity has arisen for an analytical scientist to join our global Supply Analytical Sciences (SAS) team based in Singapore. The successful candidate will join our team as a senior scientist supporting small molecule drug substance and drug product supply in our company and external partner manufacturing sites in Asia Pacific. WHAT YOU WILL DO Responsibility

• Provides comprehensive and scientifically appropriate analytical test methods to address quality requirements for release of pharmaceutical materials to be used for market supply.
• Support/Leads the development and optimization of reliable, validated, analytical methods to characterize the quality attributes of drug substances and drug products
• Assures that right information on the quality of raw materials and in-process control points is provided to support process optimization studies with a clear linkage to regulatory filing requirements.
• Manages change control for analytical methods and specifications ensuring that any changes to the methods or specifications are properly documented, justified, and implemented in a compliant manner for inclusion in the regulatory submissions
• Provides analytical information for regulatory filings and responses to question from regulatory agencies. This includes generating data, analyzing results, and responding to any queries or questions from regulatory agencies.
• Leads the transfer of analytical methods, specifications and development knowledge for the drug substance and drug products associated manufacturing process.
• Establishes relationships with partner scientific groups that facilitate a clear understanding of analytical issues and product supply.
• In partnership with the Quality organization, formulates and continually updates appropriate GMP procedures for analytical methods.
• Work with the teams of scientists to effectively coordinate and support analytical method execution in a compliant manner.

WHAT YOU MUST HAVE Qualifications, Skill & Experience Required

• Qualification (BSc, MSc, or PhD) in science with experience of analytical chemistry techniques.
• Effective communication skills and ability to work as part of cross functional team.
• Outstanding critical thinking skills.
• Ability to work in an interdisciplinary team environment.
• Strong verbal and written communication skills.
• Experience in small molecule analytical development or quality control analytical testing
• BSc minimum 4 years of experience
• MSc minimum 3 years of experience
• PhD minimum 1 year of experience

Preferred:
Extensive experience in analytical technology transfers. Who we are We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world\'s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What we look for Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us\xe2\x80\x94and start making your impact today. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Shift: Valid Driving License: Hazardous Material(s):
Requisition ID:R243157