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: Adaptability, Analytical Instrumentation, Analytical Method Development, Dissolution Testing, Driving Continuous Improvement, GMP Compliance, Karl Fischer Titrations, Laboratory Documentation, Laboratory Safety, Microbiological Analysis, Microbiological Test, Teamwork, Technical Writing, Troubleshooting, Use of Laboratory Equipment Preferred Skills:
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Employee Status: Regular Relocation:
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Job Posting End Date: 12/31/2026*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.