Scientist II, Analytical Product Development

Yoh is hiring a Scientist II, Analytics - Product Development for our pharmaceutical client in Corona, CA.

In this role, you will provide analytical support for pharmaceutical product development programs, helping advance the development and approval of generic drug products for U.S. and international markets.

Industry: Pharmaceutical / Product Development

Location:

Corona, CA

Compensation: $65,000 - $75,000 per year; based upon experience

Type:
Direct Hire

• Perform analytical testing of raw materials, in-process samples, finished products, and stability samples using compendial and non-compendial methods.
• Perform method development, evaluation, validation, and verification using HPLC, GC, and other analytical laboratory techniques.
• Utilize analytical techniques including wet chemistry, spectrometry, chromatography, and physical testing.
• Perform testing using instrumentation including HPLC, GC, UV-Vis, FTIR, Karl Fischer, balances, and other laboratory equipment.
• Accurately document laboratory testing according to Good Documentation Practices (GDP), company procedures, and applicable regulatory requirements.
• Analyze testing results and communicate findings to management in a timely manner.
• Write, review, and execute study plans, analytical protocols, validation protocols, technical transfer protocols, and associated reports.
• Author technical documents including Standard Operating Procedures (SOPs), method validation protocols/reports, and method transfer protocols/reports.
• Review laboratory documentation, including notebooks and instrument logbooks, for calculations, data entry accuracy, and regulatory compliance.
• Perform preventive maintenance, calibration, qualification, and routine monitoring of laboratory equipment and analytical instruments.
• Maintain laboratory Quality Systems related to samples, standards, reagents, equipment qualification, preventive maintenance, periodic calibration, stability chambers, and controlled-environment storage cabinets.
• Prepare sample and standard reconciliation reports and other laboratory reports as required.
• Assist with analytical data management, including data review and control charting.
• Collaborate with internal product development teams, CROs, and CMOs to establish timelines, understand analytical work requests, resolve technical issues, and communicate results.
• Support the creation of study designs, method development protocols and reports, and technology transfer protocols and reports.
• Provide timely analytical support for R&D activities associated with the development and approval of generic pharmaceutical products for U.S. and international markets.
• Utilize Microsoft Word, Excel, Outlook, and related software for data analysis, technical documentation, and communication.
• Maintain strict compliance with laboratory procedures and applicable compliance programs.
• Maintain a clean and safe laboratory work environment, including proper cleaning and storage of laboratory equipment and glassware.
• Perform additional responsibilities as assigned by management.

• Bachelor's degree in a science-related field required; advanced degree preferred.
• Minimum of three (3) to six (6) years of relevant professional experience.
• Minimum of one (1) year of experience in a relevant area of Pharmaceutical R&D.
• Strong knowledge of basic analytical chemistry principles and techniques.
• Hands-on experience with analytical instrumentation and techniques, including HPLC, GC, UV-Vis, FTIR, Karl Fischer, wet chemistry, chromatography, and spectrometry.
• Experience with analytical method development, validation, verification, and/or method transfer.
• Familiarity with pharmaceutical R&D environments, terminology, procedures, and regulatory expectations.
• Knowledge of Good Documentation Practices and laboratory compliance requirements.
• Experience preparing and reviewing analytical protocols, reports, SOPs, and other technical documentation.
• Proficiency with Microsoft Word, Excel, Outlook, and similar programs.
• Strong written and verbal English communication skills.
• Strong interpersonal skills with the ability to collaborate effectively with internal teams and external partners, including CROs and CMOs.
• Ability to organize and manage analytical activities while meeting established project timelines.
• Strong attention to detail and commitment to accurate laboratory documentation and data integrity.

Estimated Min Rate: $65000.00

Estimated Max Rate: $75000.00

Benefits include:

• Medical,…