Aptask Global Workforce (AGW) is seeking a Process Development Engineer - Hybrid for a 12+ month contract opportunity with a Global Biotechnology Company located in Thousand Oaks, CA. As a member of the process development team, the candidate will be focused on supporting senior staff to develop and characterize drug product technologies and manufacturing capabilities. This role will assist in the process validation and technology transfer of multiple products to internal manufacturing sites by executing characterization studies and experiments at the lab-scale and production scale.
Responsibilities: - Apply fundamental engineering and scientific principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materials
- Assist in the design and execution of experiments to characterize and enable implementation of new capabilities and process changes such as filling, lyophilization and analytical technologies
- Support technology transfer leads during the transfer of drug products into manufacturing sites (clinical and commercial), including make-a-batch exercises, process transfer documents, and change control assessments
- Support development of technology transfer tools (clinical and commercial) and automation of routine activities
- Effectively communicate results of characterization studies, experimental execution, and technology transfer initiatives
- Author/review/data verify technical documents, such as technical protocols, technical assessments, technical reports and draft standard operating procedures
- Conduct analysis of data generated, including statistical analysis using Minitab, JMP etc
- Development of digital tools and models by leveraging data analytics and programming skills, and AI
Requirements: - Master's degree OR Bachelor's degree and 2 years of experience OR Associate's degree and 6 years of experience OR High school diploma / GED and 8 years of experience
- B.S. in engineering or biotechnology discipline with 1-3 years experience or M.S. in engineering or biotechnology discipline with 0-2 years experience
- Familiarity with cGMP and experience in drug product / drug substance manufacturing or process development
- Knowledge of and hands-on experience with various drug product technologies
- Displayed critical thinking, problem solving and independent research skills
- Excellent project management skills and ability to elevate relevant issues to project lead and line-management
- Strong cross functional team player with good communication skills (oral and written)
- Ability to work independently and as part of a team with internal and external partners
- Good computer and organizational skills with strong attention to detail
Pay range: up to $47.34 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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