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Associate Scientist

US Tech Solutions, Inc.

Thousand Oaks, CA

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JOB DETAILS
SALARY
$26–$27.84 Per Hour
SKILLS
Analysis Skills, Artificial Intelligence (AI), Artificial Intelligence (AI) Programming Languages, Asepsis, Biochemistry, Biomedical Engineering, Biotech and Pharmaceutical, Chemical Engineering, Chemistry, Clinical Support, Computer Networks, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Analysis, Drug Design, Drug Development, Drug Products, Engineering, Experiment Design, Failure Mode and Effects Analysis (FMEA), GMP (Good Manufacturing Practices), Gap Analysis, High School Diploma, Identify Issues, Investigational New Drug (IND), Laboratory Notebook, Manufacturing, Manufacturing Operations, Manufacturing Requirements, Manufacturing Technology, Marketing Software, Modeling Languages, Performance Analysis, Performance Modeling, Pilot Plant, Presentation/Verbal Skills, Problem Solving Skills, Process Development, Process Improvement, Process Manufacturing, Process Modeling, Product Design, Product Development, Product Lifecycle Management, Product Support, Product/Service Launch, Project/Program Management, Quality Assurance Methodology, Record Keeping, Regulations, Regulatory Compliance, Regulatory Submissions, Risk Analysis, Root Cause Analysis, Sales Pipeline, Scientific Principles, Statistical Analysis System (SAS), Statistics, Statistics Software, Strategic Planning, Test Plan/Schedule, Testing, United States Department of Energy (DOE), Writing Skills
LOCATION
Thousand Oaks, CA
POSTED
16 days ago
Duration: 12 months Contract
 
Description:
  • As a member of the process development team, this role will be focused 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. The candidate will establish the experimental design, develop and implement protocols, obtain reproducible and reliable results, analyze data and communicate results to cross functional groups.
 Specific responsibilities include but are not limited to:
  • 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 manufacturing network
  • Author and review technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions
  • Provide ongoing support to clinical and commercial fill/finish manufacturing operations through troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements
  • Participate in cross-functional teams working effectively in a highly matrixed team environment to drive change, efficiency, and strong relationships
 Preferred Qualifications:
  • BS in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology with 3+ years of experience within the pharmaceutical/biotechnology industry
  • 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.) to define critical process parameters
  • Aseptic fill finish manufacturing or manufacturing technical services experience including the development of control strategies and active process performance monitoring
  • Understanding of process related stresses that impact the quality and stability of biologics
  • Ability to use engineering 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.)
  • Familiarity with Design of Experiments (DOE) and Quality by Design (QbD) principles
  • Familiarity with cGMPs, regulatory filings, and compliance issues for sterile injectable products manufactured by aseptic processing
  • Experience in a matrix team environment and interacting with Analytical Sciences, Process Development, Project Management, Manufacturing, Regulatory, Compliance, and/or Quality
  • Organizational, technical problem solving, communication (written and verbal) skills, and regular interactions
  • Ability to learn and act on dynamic information at a rapid pace
  • Familiar or ability to learn to use electronic record keeping, GMP, laboratory notebooks, statistical analysis and software.
  • Laboratory or pilot plant experience with process equipment
 Basic Qualifications:
  • Masters degree OR
  • Bachelors degree and 2 years of experience OR
  • Associates degree and 4 years of experience OR
  • High school diploma / GED and 6 years of experience.
 Top 3 Must Have Skill Sets:
  • 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.
  • Nice to have: Leverage advanced AI technologies, including generative AI, large language models (LLMs), and in silico modeling, to drive innovation and accelerate research, development, and testing processes.
  • Perform data analysis using advanced statistical/analytical techniques with a proficiency in statistical analysis software. 
Day to Day Responsibilities:
  • Plan, design, execute, and document laboratory studies related to formulation, aseptic processing, visual inspection and fill/finish process development in support of product commercialization and life cycle management
  • Apply basic science/engineering skills and first principles modeling to solve technical problems
  • Participate in Drug Product Commercialization Teams responsible for conducting process development on pipeline products, as well as, supporting commercial products in lifecycle management.
  • Perform data analysis using advanced statistical/analytical techniques with a proficiency in statistical analysis software.
  • Report authoring and presentation of scientific data to team leads.
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
 
"US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"
 
AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring.

About the Company

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US Tech Solutions, Inc.

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