Analytical Sciences Specialist

Job Description

Our Carlow site, which broke ground in 2008, is a strategic manufacturing facility supporting the launch and commercial supply of vaccines, biologics, and small molecule drug products.

Since its establishment, the site has benefited from significant investment and is home to state-of-the-art manufacturing facilities, laboratories, and temperature-controlled warehousing. As a major employer in the Southeast region, the Carlow site attracts high-performing talent through strong collaborations with local universities and colleges.

Our Carlow site is seeking an Analytical Sciences specialist to join the team.

As our Site Analytical Science Specialist, you will champion the end-to-end lifecycle management of site analytical procedures. In this role, you will lead the introduction and transfer of new analytical methods, provide expert SME assessments for equipment and method qualifications, and head technical investigations. You will also oversee product testing and deliver robust technical rationales to support site operations.

Bring energy, knowledge, and innovation to carry out the following:

• Lead new method introductions, including method validation and technical transfers across site laboratories.
• Evaluate and implement new technologies to optimize analytical performance and efficiency.
• Assessment and implementation of changes for existing methods and equipment:
  • Change in technical element of method e.g. Parameter change,
  • Change in equipment element of method e.g., column/reagent change.
• Provide expert troubleshooting for analytical methods and laboratory instrumentation to resolve complex technical issues.
• Technical SME for regulatory questions, audit support, reagent changes / supply issues to provided justification / rationale for analytical methods and equipment.
• Technical review of impact on Analytical methods and equipment as part of cross-functional team assessment of new/revised Global Test method / Compendia changes or updates.
• Analytical equipment troubleshooting.
• Initial training of end users in QC and Manufacturing and training of site analytical sciences personnel on lab systems, processes and methods where agreed.
• Investigation support for lab investigations.
• Authoring technical documentation in support of investigation and regulatory responses.
• Technical Impact Assessment of proposed and finalized compendial changes.
• Development and ownership of change control for new analytical methods.
• Routine Assay Monitoring and lifecycle management of analytical methods.
• Supporting digital method development.

What Skills You Will Need

• Bachelor’s degree in science or equivalent experience.
• 3-5 years relevant experience in the pharma industry.
• Strong experience in tech transfer/validation
• Excellent communication skills to build strong cross functional relationships

We keep patients at the heart of everything we do and are committed to addressing some of the world's most challenging healthcare needs through scientific innovation and operational excellence.

As an equal opportunity employer, we value diversity and are committed to fostering an inclusive environment where talented and committed people can thrive and contribute their best work.

Should you require support during the recruitment process, please contact the Talent Acquisition Advisor assigned to this role.

We are committed to flexible working wherever possible and have introduced a hybrid working model for eligible office-based employees. We encourage candidates to discuss any flexibility requirements during the recruitment process.

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Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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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.

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