Job Details

Target PR Range: 19-26/hr DOE
 

Role Summary

This role is within Thousand Oaks microanalytical (Forensics) team, located within Attribute Sciences (AS) department and the Process Development (PD) organization. The Process Development Associate Scientist will broadly support microanalytical investigations by generating and analyzing data, and reporting out results of experiments designed to identify and assess unknown or unexpected materials (e.g., organic, inorganic, and/or biological in origin) observed during commercial or clinical manufacturing, product complaints, and/or product development activities. The Associate Scientist will need to understand and apply state-of-the-art spectroscopic and microscopic analytical tools to forensics investigations, applying a level of documentation and compliance rigor commensurate to the responsibility to ensure that products and processes meet the highest current Good Manufacturing Practices (cGMP) quality standards.

Key Responsibilities

• Apply spectroscopic, microscopic, wet chemistry, and sample-handling techniques to characterize unexpected organic, inorganic, and/or biological materials in support of root cause investigations
• Generate, organize, analyze, and interpret analytical data under minimal supervision
• Document experiments, data, interpretations, and conclusions with rigor consistent with GDocP and cGMP expectations
• Collaborate effectively within the Forensics team by providing support for ongoing forensics investigations and seeking input from colleagues
• Communicate technical findings clearly through scientific discussions, laboratory notebook records, and presentations
• Maintain safe, compliant, and efficient laboratory operations, including use of standard laboratory equipment and major analytical instruments relevant to forensic investigations
• Contribute as-needed to internal/external reports, papers, presentations, regulatory documents, invention disclosure submissions and/or patents
• Provide as-needed support for discussions with internal and external (e.g., contract manufacturing) partners across network to drive root cause analysis, corrective actions, and investigation closure

Basic Qualifications:

• Master’s degree OR
• Bachelor’s degree and 2 years of experience (academic or industrial)

Preferred Qualifications:

• Coursework and experience focused on Analytical Chemistry, Materials Science, or related discipline
• Experience in an investigational laboratory setting within a pharmaceutical or biotechnology company
• Hands-on experience in vibrational spectroscopies such as Fourier-Transform Infrared and Raman spectroscopies
• Hands-on experience with optical and electron microscopies
• Demonstrated ability to critically analyze analytical datasets to influence the investigational process
• Strong understanding and experience of wet chemistry and sample handling
• Strong commitment to compliance with Good Documentation Practices (GDocPs) and current Good Manufacturing Practices (cGMP) standards
• Excellent written and oral communication skills for the timely documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment