Quality Control Scientist: Method Development & Validation

Bayer AG; Berkeley (CA); Presencial; USD 120 000 - 180 000; Tempo integral

Resumo da oferta

Bayer AG in Berkeley seeks a seasoned Quality Control Chemistry professional to advance analytical capabilities and drive method development and validation in a regulated pharmaceutical setting.

You will operate modern instrumentation (HPLC/UPLC, KF titrator, polarimeter) and maintain rigorous documentation while collaborating with manufacturing, research, and quality units to ensure product quality and regulatory compliance.

Qualificações

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field required.
• Master's degree or PhD in a relevant scientific discipline preferred.
• Minimum 6 years of experience in pharmaceutical or related industry with a Bachelor's degree, OR 2 years with Master's, OR PhD with relevant exposure.
• Minimum 3 years of experience in Quality Control laboratory operations.

Responsabilidades

• Support the implementation and integration of new analytical methods within the Quality Control Chemistry department.
• Maintain comprehensive logs, notebooks, and electronic documentation systems in accordance with regulatory requirements.
• Conduct method feasibility studies and method development activities to support analytical testing needs.
• Execute laboratory assays for method validation protocols utilizing various chemistry instrumentation.
• Operate and maintain analytical equipment including HPLC, UPLC, KF Titrator, Autotitrator, Melting Point meter, Chloride meter, and Polarimeter.
• Troubleshoot assays and analytical instrumentation to ensure optimal method performance and data quality.
• Prepare samples using wet chemistry techniques and various analytical methodologies.
• Generate comprehensive method development reports and method validation reports.
• Follow established SOPs, pharmacopoeial guidelines, regulatory requirements, and safety protocols.
• Manage multiple concurrent tasks while working effectively with technical leads across different projects.
• Interface and collaborate with manufacturing, research, and other cross-functional teams.
• Utilize LIMS, SAP, and chromatographic software systems for data management and analysis.

Conhecimentos

HPLC

GMP

GDP

LIMS

SAP

EMPOWER

Method development

Validation protocols

Formação académica

Bachelor's degree in Chemistry

Master's degree or PhD preferred

Ferramentas

LIMS

SAP

EMPOWER chromatographic software

HPLC/UPLC instrumentation

Descrição da oferta de emprego

Bayer AG in Berkeley seeks a seasoned Quality Control Chemistry professional to advance analytical capabilities and drive method development and validation in a regulated pharmaceutical setting.

You will operate modern instrumentation (HPLC/UPLC, KF titrator, polarimeter) and maintain rigorous documentation while collaborating with manufacturing, research, and quality units to ensure product quality and regulatory compliance.