• Full Time (Salaried)
  • , CA

Company:  Confidential

Job Title: RA/SRA, Analytical Dev. & QC

Job Number: 33163

Location: , CA

Job Description


  • Performing regular and irregular analyses on samples of in-process, toxicology, finished drug substance and drug product, such as release and stability testing.
  • Oversee the progress of new and ongoing development projects
  • Review analytical data for adherence to SOPs
  • Participate in internal and external scientific meetings
  • Collecting and documenting data for quality review
  • Revising SOPs as necessary, authoring qualification/validation protocols and reports, as well as scientific reports and portions of regulatory filings in the Chemistry, Manufacturing, and Controls (CMC) section
  • Conducting analytical investigations and potentially developing and optimizing analytical methods
  • Knowledge of cGMP and GLP standards and practices
  • May be responsible for managing one or more direct reports

Required Skills

  • A bachelor’s or master’s degree in Chemistry or a related field
  • A minimum of 5 years of experience in an analytical development and quality control role for a Research Associate, and a minimum of 10 years for a Senior Research Associate
  • Practical knowledge of HPLC, MS, and GC
  • Familiarity with cGMPs is preferred
  • Experience in following SOPs for Analytical Methods, Equipment Procedures, and Material Specifications
  • Ability to act as the technical leader of a scientific project
  • Capability to independently interpret experimental results and determine a path forward
  • Strong organizational abilities
  • Experience recording data in laboratory notebooks or data collection forms
  • Comfortable with operating and troubleshooting laboratory equipment and instrumentation
  • Effective communication skills, both written and verbal, to interact with all levels of the organization
  • Ability to meet deadlines and workloads and complete assigned tasks
  • Willingness to be flexible in job duties to support team objectives
  • Experience in managing development projects
  • Willingness to promote positive teamwork, encourage solutions, and seek feedback to resolve issues while demonstrating respect to others
  • Active listening skills and the ability to provide constructive feedback to suggestions or opinions presented.

Compensation and Benefits:
Salary range: $80,000 to $115,000/year

Health Insurance (medical, dental, vision)
Life Insurance
Short- and Long-Term Disability
Paid Time Off (PTO) – 3 weeks PTO and 16 Paid Holidays


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