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Associate Scientist (JP9301)

Thousand Oaks, ca · Biotech/Pharmaceutical
Job Title: Associate Scientist (JP9301)
Location: Thousand Oaks, CA
Employment Type: Contract
Duration: 3 years
Job posting date: 10/14/2021
Note: Onsite Essential

3 Key Consulting is hiring an Associate Scientist  for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.

Job Summary:
  • As a member of the process development team, this role will be passionate about identifying and developing aspects of drug product to advance process design for parenteral drug products.
  • The candidate will perform experiments, coordinate data, and analyze results with minimal direction.
  • The candidate will establish the experimental design, develop, and implement protocols, acquire reproducible and reliable results, analyze data and communicate results to multi-functional groups.

Day-To-Day Responsibilities:
  • 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 client 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 multi-functional teams working optimally in a highly matrixed team environment to inspire change, efficiency, and positive relationships.

Preferred Qualifications
  • MS in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology
  • 3+ years experience within the pharmaceutical/biotechnology industry
  • 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.

Top Must have Skill Sets:
  • experience within the pharmaceutical/biotechnology industry
  • Ability to learn and act on dynamic information at a rapid pace
  • 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
  • Analytical lab experience

Employee Value Proposition:
The person in this role will be working on supporting lab projects and running analytical testing and helping with process design.
Red Flags:


 
  • No PhD needed
  • No lab experiences
  • no team work

Interview Process:
1. phone screening
2. Virtual interview 


We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.



 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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