Process Development Associate - Onsite

Aptask Global Workforce (AGW) is seeking a Process Development Associate for an Onsite position with a Global Biotechnology Company located in Thousand Oaks, CA. This is a 6+ month contract opportunity.


This is a hands-on laboratory associate role supporting the Process Development team. The ideal candidate will have practical laboratory experience and be comfortable working under the direction of scientists, assisting with method development, executing studies, and supporting routine laboratory activities. The role will work collaboratively with a team of scientists to execute studies supporting microbiological method development, optimization, and troubleshooting.


Responsibilities:

• Execute laboratory studies supporting microbiological method development, optimization, troubleshooting, and validation
• Perform studies including Endotoxin method/low endotoxin recovery (LER) studies, Microbial Challenge/Hold time studies, and Bacterial Retention Testing/Sterile Filtration Studies
• Advance existing methods and implement alternative technologies, such as recombinant reagents for endotoxin testing and Monocyte Activation Test (MAT) for pyrogen testing
• Evaluate rapid microbiology methods (RMMs)
• Analyze and interpret experimental data, summarize study results, and assist with the preparation of protocols, technical assessments, and reports
• Maintain knowledge of current compendial and regulatory requirements applicable to microbiological testing and microbial control (USP, Ph. Eur., JP, Annex 1, CFRs, etc.)
• Collaborate with QC Microbiology, Process Development, Manufacturing, Quality and other functions
• Participate in and represent Process Microbiology in scientific and cross-functional meetings
• Communicate effectively with cross-functional team members, clients, and partner organizations
• Support day-to-day laboratory operations, including maintaining supplies and inventory

Requirements:

• Bachelor's degree and 2 years of microbiology or related biological science experience
• Experience in a QC Microbiology Lab
• Knowledge of compendial methods for Bioburden, Sterility and Endotoxin (USP/EP/JP)
• Hands-on testing experience
• Familiarity with current compendial standards, laboratory procedures, and applicable regulatory requirements

Desired skills:

• Hands-on experience in microbiology and aseptic techniques
• Prior experience in a Microbiological Quality Lab or similar microbiology laboratory environment
• Demonstrated 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
• Proficiency with tools used to organize and manage projects and data, such as SharePoint and Smartsheet

Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position.


If you have the described qualifications and are interested in this exciting opportunity, apply today!


Aptask Global Workforce (AGW)


ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.


Benefits of working with ApTask Global Workforce include:

• Medical
• Dental
• Vision
• Sick Pay (for applicable states/municipalities)

Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website


ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.