Senior Analytical Scientist, Pharma Product Development

Yoh, A Day & Zimmermann Company; Corona (CA); On-site; USD 75,000 - 80,000; Full time

Benefits offered by this job

Medical, Prescription, Dental & Vision

Health Savings Account (HSA)

Life & Disability Insurance

MetLife Voluntary Benefits

Employee Assistance Program (EAP)

401K Retirement Savings Plan

Direct Deposit & weekly epayroll

Referral Bonus Programs

Certification and training机会

Job summary

Yoh, a Day & Zimmermann company, is seeking a Scientist III, Analytics – Product Development in Corona, CA to provide advanced analytical support for pharmaceutical R&D focused on generics. You will independently perform testing, method development, validation and regulatory documentation with CRO/CMO collaboration.

The ideal candidate has 5–10 years in pharma R&D, strong analytical chemistry expertise and working knowledge of FDA/ICH guidelines.

Qualifications

• Bachelor's degree in Chemistry, Biological Sciences, or a related scientific discipline required.
• Minimum of five (5) to ten (10) years of relevant Pharmaceutical R&D experience with demonstrated accomplishments.
• Strong expertise in analytical chemistry principles, methodologies, and laboratory techniques.
• Extensive hands-on experience with HPLC, GC, UV-Vis, FTIR, Karl Fischer, wet chemistry, spectrometry, chromatography, and related analytical instrumentation.
• Demonstrated experience with analytical method development, evaluation, validation, verification, and technology transfer.
• Strong knowledge of laboratory Quality Systems, safety requirements, and laboratory support processes.
• Thorough familiarity with FDA and ICH guidelines and other applicable pharmaceutical regulatory requirements.
• Knowledge of cGMP and cGLP requirements within a pharmaceutical R&D environment.
• Experience conducting and documenting OOS, OOT, and aberrant result investigations, including root cause analysis and CAPA.
• Experience reviewing CMC and analytical documentation supporting regulatory submissions.
• Demonstrated ability to independently write SOPs, policies, guidance documents, analytical study plans, protocols, and technical reports.
• Strong understanding of pharmaceutical terminology, laboratory operations, and regulatory expectations.
• Strong written and verbal English communication skills.

Responsibilities

• Independently perform analytical testing with limited or no supervision and communicate results to management within established timelines.
• Perform testing of raw materials, in-process samples, finished products, and stability samples using compendial and non-compendial methods.
• Perform analytical method development, evaluation, validation, and verification utilizing HPLC, GC, and other laboratory techniques.
• Conduct analytical testing using wet chemistry, spectrometry, chromatography, physical testing, and other applicable techniques.
• Operate analytical instrumentation including HPLC, GC, UV-Vis, FTIR, Karl Fischer, balances, and other laboratory equipment.
• Accurately document all laboratory testing in accordance with Good Documentation Practices, company policies, and applicable regulatory requirements.
• Write, review, and execute analytical study plans, protocols, and reports.
• Develop and review method development, method validation, and technology transfer protocols and reports.
• Author technical documentation, including SOPs, policies, guidance documents, validation protocols, and method transfer documentation.
• Review laboratory notebooks, instrument logbooks, calculations, and data entries for accuracy, completeness, and regulatory compliance.
• Conduct thorough laboratory investigations of OOS, OOT, and other aberrant analytical results.
• Determine root causes of laboratory investigations, develop and implement CAPAs, and prepare investigation reports.
• Review CMC documentation and related analytical documents for regulatory submissions.
• Perform gap assessments of CMC and analytical documentation and provide recommended actions to management.
• Support cGMP, cGLP, and safety audits conducted by FDA, OSHA, client companies, and other regulatory organizations.
• Maintain familiarity and compliance with applicable FDA, ICH, and other regulatory guidelines and requirements.
• Perform preventive maintenance, calibration, and qualification of laboratory equipment and analytical instruments.
• Maintain laboratory Quality Systems related to samples, standards, reagents, equipment qualification, preventive maintenance, calibration, stability chambers, and controlled-environment storage cabinets.
• Collaborate with internal Product Development teams, CROs, and CMOs to establish timelines, understand analytical work requests, identify and resolve issues, and communicate results.
• Support study design and ensure analytical development and technology transfer activities are completed in accordance with regulatory requirements and timelines.
• Provide effective and timely analytical support for R&D activities associated with generic drug development and approvals for U.S. and international markets.
• Prepare sample and standard reconciliation reports and other analytical reports as required.
• Support QC data management activities, including data review and control charting.
• Utilize Microsoft Word, Excel, Outlook, and related applications for data analysis, technical documentation, and communication.
• Maintain strict adherence to laboratory compliance and safety programs.
• Maintain a clean and safe laboratory environment, including proper cleaning and storage of laboratory equipment and glassware.
• Perform additional laboratory activities and responsibilities as assigned by management.

Skills

Analytical testing

Method development

Regulatory knowledge

Documentation

OOS/OOT investigations

GxP compliance

Team collaboration

FDA/ICH knowledge

English communication

Education

Bachelor's degree in Chemistry or related

Tools

HPLC

GC

UV-Vis

FTIR

Karl Fischer

Wet chemistry

Job description

Yoh, a Day & Zimmermann company, is seeking a Scientist III, Analytics – Product Development in Corona, CA to provide advanced analytical support for pharmaceutical R&D focused on generics. You will independently perform testing, method development, validation and regulatory documentation with CRO/CMO collaboration.

The ideal candidate has 5–10 years in pharma R&D, strong analytical chemistry expertise and working knowledge of FDA/ICH guidelines.