QC Senior Scientist 1

MilliporeSigma; Carlsbad (CA); Sur place; USD 68 000 - 99 000; Plein temps

Avantages offerts par ce poste

Health insurance

Paid time off

Retirement contributions

Résumé du poste

MilliporeSigma in Carlsbad, CA is seeking a QC Senior Scientist I to support daily Quality Control operations, performing a wide range of analytical tests from raw materials to final product under cGMP guidelines.

You will collaborate with internal and external teams, aid method transfers and stability programs, and mentor junior analysts while maintaining a safe, compliant laboratory environment.

Qualifications

• Bachelor’s Degree in Biology, Chemistry or related Life Science discipline.
• 6-10 years of experience in the biopharmaceutical industry.
• OR
• Master’s Degree in Biology, Chemistry or related Life Science discipline
• 5+ years of experience in the biopharmaceutical industry.
• OR
• PhD in Biology, Chemistry or related Life Science discipline
• 3+ years of experience in the biopharmaceutical industry.

Responsabilités

• Perform a wide variety of analytical testing methods including raw material, in-process, and final product testing.
• Support lab readiness for testing and client audits.
• Assist SOP generation, protocol generation, data summarization, and reporting.
• Support change controls, CAPAs, investigations, and related documentation.
• Support method onboarding, transfers, qualifications, and validations.
• Support stability programs, including scheduling and timelines.
• Coordinate raw material qualification activities for commercial clients and reporting.
• Communicate with internal/external network partners and Product Teams.
• Promote a safety-first culture.
• Act as a resource for junior analysts.

Connaissances

Analytical testing

Data analysis

GMP documentation

Regulatory audits support

Formation

Bachelor’s Degree in Biology, Chemistry or related Life Science discipline

Master’s Degree in Biology, Chemistry or related Life Science discipline

PhD in Biology, Chemistry or related Life Science discipline

Outils

ELISA

HPLC/UPLC

qPCR/ddPCR

Spectroscopy

Cell culture

CE-SDS

Description du poste

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.

Your Role

As a QC Senior Scientist I, you will support the daily operations of the Quality Control Group activities which include performing a wide variety of analytical testing methods including raw material testing for raw materials, consumables, stability, in-process, and final product testing. The role will entail operating in a fast-paced, highly dynamic environment with multifunctional groups/departments, including both internal and external stakeholders as needed.

• Support the daily operations of the Quality Control group to ensure raw materials, consumables, stability, in-process, and final product testing are completed by assigned deadline (i.e. pH, Osmolality, TOC, Conductivity, Chemical ID, HPLC, FTIR, CE-SDS, Biochemical analysis, ELISAs, Cell Culture, PCR (qPCR & ddPCR, etc.).
• Supports the daily operations of the Quality Control group to ensure lab is in a state of readiness for both testing and client audits.
• Supports SOP generation and revisions, item specification revisions, protocol generation, final report preparation, data summary, testing, and data trending.
• Supports management of change controls, CAPAs, investigations, and other related documentation as needed.
• Supports method onboarding, including method transfers, qualifications, and validations as needed.
• Supports stability programs as needed, including pull forecasts, scheduling, and adherence to timelines.
• Supports raw material qualification activities for commercial clients as needed, including coordinating material acquisition, qualification testing, and reporting within provided timelines.
• Communicate effectively with the internal and external network partners, and the Product Teams
• Promote a safety-first culture
• Act as potential resource of information for the junior analysts

Who You Are

Minimum Qualifications

• Bachelor’s Degree in Biology, Chemistry or related Life Science discipline
• 6-10 years of experience in the biopharmaceutical industry

OR

• Master’s Degree in Biology, Chemistry or related Life Science discipline
• 5+ years of experience in the biopharmaceutical industry

OR

• PhD in Biology, Chemistry or related Life Science discipline
• 3+ years of experience in the biopharmaceutical industry

Preferred Qualifications

• Experience in Quality Control performing analytical methods such as Compendial testing, FTIR, UHPLC, Spectroscopy, CE-SDS, Cell Culture, ELISA, PCR (ddPCR & qPCR), Potency, FFU, PFU, and Flow Cytometry.
• Experience with providing technical advice and support for client and regulatory audits/inspections via meetings/teleconferences.
• Experience managing Stability programs
• Experience managing Raw Material qualification activities
• Experience onboarding new methods into QC (Method Transfers, Qualifications, and Validations)
• Strong critical and analytical thinking skills for effective problem-solving and outcome improvement.
• Knowledge of cGMP manufacturing and quality systems within an FDA-regulated environment and ICH quality guidelines.
• Technical Skills: Proficiency in analytical techniques (e.g., ELISA, HPLC/UPLC, qPCR/ddPCR, spectroscopy, cell-based assays); GMP documentation, instrument maintenance; basic programming or data analysis tools.
• Regulatory/Quality: Knowledge of governmental regulatory guidelines relating to the manufacturing of biologics (cGMP, ICH guidelines, and QA/QC systems); Experience with Quality Management Systems to document investigations, change controls, and CAPAs.
• Soft Skills: Excellent scientific communication (written and oral), problem-solving, time management, collaboration, adaptability, and mentoring ability.

Pay Range for this position: $68,000-$98,900 per year. The offer range represents the anticipated low and high end of the base pay compensation for this position. 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. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites.

What we offer

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!