Job Description

An amazing opportunity has arisen for a Scientist, Analytical R&D. The Global Quality Large Molecule Analytical Sciences Organization is at the forefront of supporting pipeline and commercial products within a multi-product commercialization biologics facility. Our Analytical Science Team is committed to ensuring analytical methods are robust and ready for quality control (QC), facilitating end-to-end method lifecycle management.

What you will do:

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

Conduct compendial and non-compendial analytical method verification/validation for drug substances and raw materials.Provide analytical method support for new product introductions, including new technology introduction.Involve in the development, troubleshooting, and optimization of analytical methods to ensure their robustness and QC readiness.Assess and implement changes to existing methods and equipment, including technical troubleshooting in cross-functional investigations.Interface across our Company network and with external partners to ensure the successful commercialization of assays promoting our pipeline programs.Perform technical reviews to evaluate the impact of new/revised global test methods and compendial changes as part of a cross-functional team.Contribute to the assessment of analytical methods and equipment regarding proposed compendial changes.Partner with sister sites for analytical transfers and standardization efforts.Participate in internal and external audits and inspections, ensuring department compliance and readiness.Strong industry knowledge and GMP understandingMaintain contacts within the scientific community and monitor industry trends, new technology initiatives, and worldwide regulatory guidance.Support routine Real Time Data Trending (RTDT) and lifecycle management of analytical methods.Oversee the Performance Qualification (PQ) aspect of equipment qualification, supporting Installation Qualification (IQ) and Operational Qualification (OQ) as needed.Author technical documentation for investigations and regulatory responses.Serve as an analytical impact assessor for analytical change controls.Engage in routine assay monitoring and lifecycle management of analytical methods.Support digital method development initiatives.

What skills you will need:

In order to excel in this role, you will more than likely have:

Bachelor’s degree in Biochemistry, Analytical Science, or a related fieldMinimum of 3 years of experience in analytical method introduction and qualification within the biopharmaceutical and/or pharmaceutical industry, with a comprehensive understanding of the end-to-end manufacturing process.Proficient in analytical methods, including but not limited to HPLC, UPLC, CEKnowledge of ICH, USP, and other compendial chapters required for method transfer and validation, particularly in late-stage method development, validation, and transfer.Flexible and self-motivated with the ability to manage multiple priorities effectively.Strong project management and stakeholder management skills, with a proven ability to influence internal and external stakeholders.Demonstrated capability to work collaboratively as part of a team and independently to ensure prioritization and progress.Excellent problem-solving skills, including risk management, decision-making, and troubleshooting abilities.

As a company, we are committed to ‘Inventing for Life’ in all that we do. 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. 

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply 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:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

02/28/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R334503