Senior Engineer - Drug Product Process Engineering
Amgen
- Thousand Oaks, CA
- $114,962-139,704 per year
- Permanent
- Full-time
- Work with a team of process scientists and/or engineers to design, implement, document, and generate primary data packages related to process development and technology transfer, while applying their experience in aseptic processing, equipment, automation, and unit operation characterization
- Act as a drug product technical specialist, to provide leadership and solutions for parenteral product manufacturing, for all unit operations including but not limited to formulation, filtration, filling, capping, lyophilization and visual inspection.
- Support continuous improvements in the drug product development process through technological innovation and application of first principles in process engineering
- Support technology transfers of pipeline and commercial products as well as lifecycle management of products for a variety of parenteral modalities
- Deliver progress reports and presentations to engage with and ensure that management is aware of the current status and progress
- Participate in global multi-functional teams, working effectively in a highly matrixed team environment to advance programs through clinical manufacturing and the commercialization process
- M.S. or PhD in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology or related field
- 5+ years of drug product process development experience in the pharmaceuticals/biotechnology industry
- Familiarity with aseptic processing, drug product manufacturing, drug product manufacturing, cGMPs, statistical design, analysis of experiments, and process characterization
- Process scale-up and technology transfer experience including the use of gap analysis, root cause analysis, and risk assessment tools
- The ability to use engineering principles to demonstrate bench and pilot scale models for process performance characterization
- Experience in a matrix team environment, in particular interacting with Attribute Sciences, Process Development, Project Management, Manufacturing, Regulatory, Compliance, and/or Quality
- Knowledge of bringing new products to market, across various dosage forms and delivery systems
- Knowledge of associated GMP/Device documentation and regulatory filings
- Experience with conducting statistical evaluations of data to evaluate statistical significance, assess potential correlations, evaluate process capability and/or perform Monte Carlo simulations.
- Ability to learn and act on dynamic information at a rapid pace
- Ability to travel domestically and internationally up to 25% of the time
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible