Process Development Senior Associate

Target PR Range: open market rate

Job Summary:

The Thousand Oaks Cellular Sciences organization is seeking an enthusiastic, highly motivated, and team-oriented individual with a background in microbiology for the position of Process Development Associate within the Process Microbiology Group. The Process Microbiology Group supports the global network by providing scientific and technical expertise for trouble shooting microbiological methods across various analytical platforms, as well as compendial methods and technologies related to microbial control.

The PD Associate will work collaboratively with a team of scientists to execute studies supporting microbiological method development, optimization, and troubleshooting. The role will primarily focus on laboratory execution while also contributing to study design, data analysis, as well as support scientists in drafting protocols/summary reports. Activities also include the evaluation of new technologies/rapid microbiology methods (RMM).

The successful candidate will perform studies independently and collaborate with scientists on study execution, support team on data analysis and drafting of protocols/summary reports. In addition, the PD Associate will interface with QC and other cross-functional partners and represent the Process Microbiology team in scientific and technical discussions.

Responsibilities:

• Execute laboratory studies supporting microbiological method development, optimization, troubleshooting, validation including (but not limited to):
  • Endotoxin method/low endotoxin recovery (LER) studies
  • Microbial Challenge/Hold time studies
  • Bacterial Retention Testing/Sterile Filtration Studies
  • Advancement of existing methods and implementation of alternative technologies, such as recombinant reagents for endotoxin testing and Monocyte Activation Test (MAT) for pyrogen testing
  • Evaluation of RMMs
• Analyze and interpret experimental data, summarize study results, and assist with the preparation of protocols, technical assessments, reports
• Maintain knowledge of current compendial and regulatory requirements applicable to microbiological testing and microbial control, including USP, Ph. Eur., JP, and relevant regulatory guidance (Annex 1, CFRs, etc.)
• Collaborate with QC Microbiology, Process Development, Manufacturing, Quality and other functions to support the network
• Participate in and represent Process Microbiology in scientific and cross-functional meetings, including communicating study progress, study results, and technical findings
• Communicate effectively and efficiently with cross-functional team members, clients, and partner organizations
• Support day-to-day laboratory operations, including maintaining laboratory supplies and inventory, coordinating ordering of materials, and ensuring appropriate supplies are available to support study execution

Basic Qualifications:

Bachelor’s degree and 2 years microbiology, related biological science experience

Preferred Qualifications

• Hands-on experience in microbiology and aseptic techniques.
• Prior experience in Microbiological Quality Lab or similar microbiology laboratory environment
• Demonstrate the ability to understand, apply, and evaluate microbiological principles
• Experience with compendial microbiological methods, including bioburden, bacterial endotoxins, and/or sterility testing
• Detail-oriented with strong laboratory documentation and technical writing skills.
• Ability to independently organize and execute laboratory studies while effectively managing multiple priorities and timelines
• Effective written and verbal communication skills with the ability to work independently as well as collaboratively in cross-functional teams
• Proficiency with tools used to organize and manage projects and data, such as SharePoint and Smartsheet