Scientist III - Analytical Development

Yoh is hiring a Scientist III, Analytics – Product Development for our pharmaceutical client in Corona, CA. In this role, you will provide advanced analytical, quality, and laboratory support for pharmaceutical R&D programs focused on the development and approval of generic drug products for U.S. and international markets. The Scientist III will independently perform analytical testing, method development and validation, laboratory investigations, technical documentation, and regulatory support while collaborating with internal Product Development teams, CROs, and CMOs. The ideal candidate will bring extensive pharmaceutical R&D experience, strong analytical chemistry expertise, and a thorough understanding of FDA, ICH, cGMP, and cGLP requirements.

Industry: Pharmaceutical / Product Development
Location: Corona, CA
Compensation: 80k + ; based upon experience
Type: Direct Hire

Job Functions

• 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 Standard Operating Procedures (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 Out-of-Specification (OOS), Out-of-Trend (OOT), and other aberrant analytical results.
• Determine root causes of laboratory investigations, develop and implement appropriate Corrective and Preventive Actions (CAPAs), and prepare investigation reports.
• Review Chemistry, Manufacturing, and Controls (CMC) documentation and related analytical documents for regulatory submissions.
• Perform gap assessments of CMC and analytical documentation and provide recommended courses of action 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, periodic 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 established timelines.
• Provide effective and timely analytical support for R&D activities associated with the development and approval of generic drug products 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.

Education, Licensure and/or Experience

• 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.
• Excellent interpersonal skills with the ability to collaborate effectively with internal teams and external partners, including CROs and CMOs.
• Ability to independently manage multiple priorities and complete assignments with limited supervision.
• Proficiency with Microsoft Word, Excel, Outlook, and similar applications.
• Familiarity with pharmaceutical information systems, computers, office equipment, and related administrative procedures.

Physical Job Requirements

• Pharmaceutical R&D laboratory and office environment.
• Regularly required to perform hands-on analytical laboratory testing and operate analytical instrumentation and equipment.
• Regular handling of laboratory samples, standards, reagents, chemicals, and glassware in accordance with established safety procedures.
• Regular use of computers and related systems for data analysis, technical documentation, and communication.
• Must be able to maintain a clean, organized, and safe laboratory workspace while adhering to laboratory safety and compliance requirements.

#IND-SPG

Estimated Min Rate: $75000.00
Estimated Max Rate: $80000.00


What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

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