Aptask Global Workforce (AGW) is seeking an Associate Scientist for an Onsite position with a Global Biotechnology Company located in Thousand Oaks, CA. This is a 12+ month contract opportunity. As a member of the process development team, this role will focus on identifying and developing aspects of drug product to advance process design for parenteral drug products. The candidate will perform experiments, organize data, and analyze results with minimal supervision, establishing experimental design, implementing protocols, and communicating findings to cross-functional groups.
Responsibilities: - Plan, design, execute, and document laboratory studies related to formulation, aseptic processing, visual inspection, and fill/finish process development
- Design, execute and document primary data packages related to drug product design and process development, and communicate key findings in presentations
- Develop solutions to technical problems during process characterization and aseptic manufacturing
- Support one or more clinical and commercial process introductions or process transfers into the manufacturing network
- Author and review technical protocols, reports, product impact assessments, and regulatory sections
- Provide ongoing support to clinical and commercial fill/finish manufacturing operations through troubleshooting and root cause analysis
- Participate in cross-functional teams to drive change, efficiency, and strong relationships
- Apply basic science/engineering skills and first principles modeling to solve technical problems
- Perform data analysis using advanced statistical/analytical techniques
Requirements: - Master's degree OR Bachelor's degree and 2 years of experience OR Associate's degree and 4 years of experience OR High school diploma / GED and 6 years of experience
- Aseptic fill finish manufacturing or manufacturing technical services experience including the development of control strategies and active process performance monitoring
- Ability to use scientific principles to leverage bench and pilot scale models for process performance characterization
- Fill/finish process scale-up and technology transfer experience including the use of gap analysis, root cause analysis, and risk assessment tools (e.g. Fish bone diagrams, FMEA, etc)
- Perform data analysis using advanced statistical/analytical techniques with a proficiency in statistical analysis software
Desired skills: - BS/MS in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology
- Experience in development/characterization of aseptic fill/finish unit operations (freeze/thaw, mixing, sterile filtration, filling, stoppering, visual inspection, etc)
- Understanding of process related stresses that impact the quality and stability of biologics
- Familiarity with Design of Experiments (DOE) and Quality by Design (QbD) principles
- Familiarity with cGMPs, regulatory filings, and compliance issues for sterile injectable products
- Experience leveraging advanced AI technologies, including generative AI, large language models (LLMs), and in silico modeling
- Laboratory or pilot plant experience with process equipment
Pay range: up to $28.85 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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