Job Description

Our Quality group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.  Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Senior Chemist is responsible for supporting QC testing activities for Finished Products and incoming Packaging Components, ensuring compliance with cGMP, regulatory requirements, and site procedures. The role provides technical expertise, supports laboratory investigations, coaches junior staff, drives continuous improvement initiatives, and maintains inspection readiness.

WHAT WILL YOU DO

Key Responsibilities

• Perform and review testing of finished products, cleaning samples, and/or incoming packaging components.
• Review and release laboratory results in compliance with approved procedures and specifications.
• Lead or support laboratory investigations (OOS, OOT, deviations, atypical results) and implement effective CAPAs.
• Provide technical troubleshooting and support method transfer, validation, verification, and equipment qualification activities.
• Author and review SOPs, test methods, protocols, reports, and other quality documents.
• Train, qualify, and mentor laboratory personnel while maintaining analyst qualification records.
• Support regulatory inspections, internal audits, and inspection readiness activities.
• Monitor laboratory metrics, identify improvement opportunities, and lead continuous improvement initiatives.
• Ensure effective management of laboratory equipment, reagents, reference standards, and consumables.

WHAT YOU MUST HAVE 

Qualifications 

• Bachelor's degree in chemistry, Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific discipline.
• With at least 5 years or more relevant experience in the pharmaceutical industry are preferred.
• Strong knowledge of cGMP, GLP, Data Integrity, laboratory investigations, and regulatory requirements.
• Proficient in analytical and physical testing techniques, including HPLC, dissolution, Karl Fischer, spectroscopy and wet chemistry.
• Experience with laboratory systems such as Empower, LIMS/GLIMS and SAP preferred.
• Strong technical troubleshooting, communication, coaching, and cross-functional collaboration skills.
• Demonstrated ability to lead initiatives, mentor staff, and drive continuous improvement.
• Good leadership skills, excellent working attitude and able to work well in teams.

Required Skills:

Preferred Skills:

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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:

Relocation:

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Travel Requirements:

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