Vacancy expired!
Requirements: Experience in drug product filling Laboratory or pilot plant experience with process equipment BS 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. 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 Familiar or ability to learn to use electronic record keeping, GMP, laboratory notebooks, statistical analysis and software. Job Description: 50% onsite Perform experiments, organize data and analyze results with minimal supervision. Establish the experimental design, develop and implement protocols, obtain reproducible and reliable results, analyze data and communicate results to cross functional groups. 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 Amgen 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 Equal Opportunity Employer/Veterans/DisabledTo read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/The Company will consider qualified applicants with arrest and conviction records
- ID: #44408354
-
State: California
Simivalley
93062
Simivalley
USA
- City: Simivalley
- Salary:
USD
TBD
TBD
- Job type: Permanent
- Showed: 2022-07-27
- Deadline: 2022-09-24
- Category: Et cetera