Aptask Global Workforce (AGW) is seeking a Scientist for a Hybrid position with a Global Biotechnology Company located in Thousand Oaks, CA. This is a 6+ month contract opportunity. This role will support microbiology-related methods such as endotoxin, bioburden, sterility, and other compendial methods associated with microbial control. The ideal candidate will have hands-on laboratory experience including method troubleshooting, and involvement in evaluating new technologies related to rapid microbiology methods. The candidate will be part of a team that supports various microbiology methods in various stages of the product life cycle, collaborating with Process Development, Manufacturing, and Quality departments.
Responsibilities: - Work on validations and studies to support QC labs as needed (e.g., rapid micro methods, LER troubleshooting)
- Help develop and execute sterile filter validations
- Attend meetings with QC and provide micro method technical support as needed
- Assist in reviewing regulation and pharmacopeia changes and determine overall impact
- Review protocols and summary reports executed by contract testing labs
- Develop and execute feasibility and/or validation studies
Requirements: - Doctorate Degree OR Master's Degree and 4 years of Scientific Experience OR Bachelor's degree and 6 years of Scientific experience
- Experience in a QC Microbiology Lab
- Knowledgeable on regulations (FDA CFRs, EMA Annex 1, Pharmacopeias)
- Experience in troubleshooting methods (endotoxin/LER) and sterile filter validation
- Must be willing to work 5 days onsite when needed
Desired skills: - Prior experience in Microbiological Quality at the technical level, including experience with sterile filtration validations
- Advanced understanding and hands-on experience in various analytical platforms such as compendial microbial methods, rapid methods for microbial detection/identification and advanced technologies for detection of bacteria
- Excellent written and oral communication skills
- Advanced ability to critically analyze and interrogate various analytical data sets to drive and influence the investigational process
- Advanced root cause analysis capabilities including leading advanced and complex events
- Expert in an investigational laboratory setting within a pharmaceutical or biotechnology company
- Advanced experience in working closely with scientific and manufacturing disciplines across process development, clinical, and commercial operations
- Familiarity with cGMP regulations, FDA and EU regulations and guidelines
Pay range: up to $42.16 per hour
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.
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