Quality Control Validation Scientist

About the role

Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Responsibilities

• Execute analytical method validations to support testing of raw materials, intermediates, stability samples, and finished goods.
• Operate strictly in accordance with ICH and cGMP guidelines to ensure testing processes meet highest regulatory standards for product quality and compliance.
• Perform analytical method and cleaning validations to support release of commercial products, preferably with prior pharmaceutical industry experience.
• Write method-specific protocols, standard operating procedures (SOPs), and comprehensive final reports for assigned validation projects.
• Execute and review laboratory testing in strict accordance with Good Documentation Practices (GDP) and specific validation protocols.
• Lead technical troubleshooting and process improvement initiatives to optimize laboratory performance, managing project milestones for internal and external stakeholders to ensure on-time, high-quality deliverables.
• Draft and review analytical methods, equipment procedures, and operational protocols for non-validated methods as assigned.
• Perform technical reviews of assays and other GMP documentation while actively working in accordance with current cGMPs and championing proper laboratory safety and housekeeping practices.

Qualifications

Minimum Qualifications: Bachelor’s degree in Chemistry, Biochemistry, Biology, or other life science discipline; 5+ years of GMP experience in the pharmaceutical, biopharmaceutical or chemical industry.

Preferred Qualifications: 2+ years of experience validating analytical methods and cleaning methods; experience performing, reviewing, and troubleshooting analytical methods for bio-organics, proteins, or bio-conjugate products, using techniques such as UV, HPLC, GC, iCE, CGE, and wet chemistry; strong background in technical writing, root cause analysis, and scientific reasoning; proven ability to communicate effectively within cross-functional teams and collaborate directly with external customers.

Benefits

• Health insurance
• Paid time off (PTO)
• Retirement contributions
• Other perquisites

Pay

Pay range: $64,900 – $107,900 annually. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses.