QC Senior Scientist 1

Merck•Carlsbad, CA

About The Position

The QC Senior Scientist I supports daily Quality Control operations by performing a broad range of analytical testing for raw materials, consumables, stability samples, in-process materials, and final products. The role works in a fast-paced, dynamic environment with multifunctional groups and internal and external stakeholders, and helps ensure testing is completed by assigned deadlines and the laboratory is ready for testing and client audits. The position also supports procedures and specifications, protocols and reports, data summaries and trending, change controls, CAPAs, investigations, method onboarding and validation, 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.
Knowledge of governmental regulatory guidelines relating to biologics manufacturing, including cGMP, ICH guidelines, and QA/QC systems.
Experience with Quality Management Systems for documenting investigations, change controls, and CAPAs.
Proficiency in analytical techniques such as ELISA, HPLC/UPLC, qPCR/ddPCR, spectroscopy, and cell-based assays.
Proficiency with GMP documentation and instrument maintenance.
Strong written and oral scientific communication, problem-solving, time management, collaboration, adaptability, and mentoring ability.

Nice To Haves

Quality Control experience 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.
Strong critical and analytical thinking skills for effective problem-solving and outcome improvement.
Basic programming or data analysis tools.

Responsibilities

Perform analytical testing for 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, PCR, qPCR, and ddPCR.
Support daily QC operations and ensure assigned testing is completed by deadlines.
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 adherence to timelines.
Support raw material qualification activities for commercial clients, including coordinating material acquisition, qualification testing, and reporting within provided timelines.
Communicate effectively with internal and external network partners and Product Teams.
Promote a safety-first culture.
Serve as a potential information resource for junior analysts.