QC Senior Scientist 1

The businesses of Merck KGaA, Darmstadt, Germany•Carlsbad, CA

3d•$68,000 - $98,900

About The Position

The QC Senior Scientist I supports daily Quality Control Group operations by performing a wide variety of analytical tests on raw materials, consumables, stability samples, in-process materials, and final products. Testing may include pH, osmolality, TOC, conductivity, chemical identification, HPLC, FTIR, CE-SDS, biochemical analysis, ELISAs, cell culture, and PCR methods such as qPCR and ddPCR. The role works in a fast-paced, dynamic environment with multifunctional groups and internal and external stakeholders. The position helps maintain laboratory readiness for testing and client audits; supports procedures, specifications, protocols, reports, data summaries, testing, and trending; and assists with change controls, CAPAs, investigations, method onboarding, stability programs, and raw-material qualification activities. The scientist communicates with network partners and Product Teams, promotes a safety-first culture, and may serve as an information resource for junior analysts.

Requirements

Bachelor’s degree in Biology, Chemistry, or a related life science discipline and 6–10 years of experience in the biopharmaceutical industry; or a master’s degree in one of these fields and 5 or more years of experience; or a PhD in one of these fields and 3 or more years of experience.
Strong critical and analytical thinking skills for problem-solving and improving outcomes.
Knowledge of cGMP manufacturing and quality systems in an FDA-regulated environment and ICH quality guidelines.
Proficiency in analytical techniques such as ELISA, HPLC/UPLC, qPCR/ddPCR, spectroscopy, and cell-based assays.
Knowledge of GMP documentation and instrument maintenance, and basic programming or data-analysis tools.
Knowledge of governmental regulatory guidelines for biologics manufacturing, including cGMP, ICH guidelines, and QA/QC systems.
Experience with Quality Management Systems for documenting investigations, change controls, and CAPAs.
Excellent written and oral scientific communication, problem-solving, time management, collaboration, adaptability, and mentoring skills.
Must be eligible to work in the United States; the role does not offer work-authorization sponsorship.

Nice To Haves

Experience in Quality Control performing analytical methods such as compendial testing, FTIR, UHPLC, spectroscopy, CE-SDS, cell culture, ELISA, PCR (ddPCR and qPCR), potency, FFU, PFU, and flow cytometry.
Experience providing technical advice and support for client and regulatory audits or inspections through meetings or teleconferences.
Experience managing stability programs.
Experience managing raw-material qualification activities.
Experience onboarding new methods into QC, including method transfers, qualifications, and validations.

Responsibilities

Perform analytical testing of raw materials, consumables, stability samples, in-process materials, and final products, including methods such as pH, osmolality, TOC, conductivity, chemical identification, HPLC, FTIR, CE-SDS, biochemical analysis, ELISA, cell culture, and PCR.
Support daily Quality Control Group operations and help ensure testing is completed by assigned deadlines.
Help maintain the laboratory in a state of readiness for testing and client audits.
Support generation and revision of SOPs and item specifications, protocol generation, final report preparation, data summaries, testing, and data trending.
Support management of change controls, CAPAs, investigations, and related documentation.
Support method onboarding, including method transfers, qualifications, and validations.
Support stability programs, including pull forecasts, scheduling, and timeline adherence.
Support commercial client raw-material qualification activities, including coordinating material acquisition, qualification testing, and reporting within provided timelines.
Communicate with internal and external network partners and Product Teams.
Promote a safety-first culture.
Serve as a potential information resource for junior analysts.