3key Consulting, Inc.
Engineer, Biotech - Processing & Manufacturing (JP10528)
3key Consulting, Inc., Thousand Oaks, California, United States, 91362
Overview
Job Title:
Engineer, Biotech Processing & Manufacturing (JP10528)
Location:
Thousand Oaks, CA. (Hybrid - 50% onsite)
Employment Type:
Contract to Hire
Business Unit:
Commercial Drug Product
Duration:
1 year with likely extension of conversion to FTE
Posting Date:
7/7/2022
Overview of Role 3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company. 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. 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.
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 company 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
Qualifications
MS in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology
3+ years of 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. Fishbone 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
Strong organizational, technical problem solving, and communication skills
Ability to learn and act on dynamic information rapidly
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
Skills Requirements:
BS in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology with 3+ years of experience within the pharmaceutical/biotechnology industry
Why is the Position Open? Staff Augmentation
Top Must-Have Skill Sets
Experience in drug product filling
Laboratory experience
Employee Value Proposition To work for a dynamic team
Interview process Phone screen with hiring manager
In person or phone interviews with 3-4 team members
How to Apply Qualified candidates may send their resume to recruiting at 3keyconsulting dot com. If you are not interested in this position, please consider other positions on our website: www.3keyconsulting.com/careers.
#J-18808-Ljbffr
Engineer, Biotech Processing & Manufacturing (JP10528)
Location:
Thousand Oaks, CA. (Hybrid - 50% onsite)
Employment Type:
Contract to Hire
Business Unit:
Commercial Drug Product
Duration:
1 year with likely extension of conversion to FTE
Posting Date:
7/7/2022
Overview of Role 3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company. 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. 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.
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 company 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
Qualifications
MS in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology
3+ years of 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. Fishbone 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
Strong organizational, technical problem solving, and communication skills
Ability to learn and act on dynamic information rapidly
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
Skills Requirements:
BS in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology with 3+ years of experience within the pharmaceutical/biotechnology industry
Why is the Position Open? Staff Augmentation
Top Must-Have Skill Sets
Experience in drug product filling
Laboratory experience
Employee Value Proposition To work for a dynamic team
Interview process Phone screen with hiring manager
In person or phone interviews with 3-4 team members
How to Apply Qualified candidates may send their resume to recruiting at 3keyconsulting dot com. If you are not interested in this position, please consider other positions on our website: www.3keyconsulting.com/careers.
#J-18808-Ljbffr