1 Amgen Center Dr. Thousand Oaks, CA 91320 US
Pay range is $33 - $36 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.
THE PROMISES WE MAKE:
At Crystal Equation, we empower people and advance technology initiatives by building trust. Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. We will serve to empower you along the way and provide the path for your professional journey.
Top 3 Must Have Skill Sets:
- Strong academic background or commercial GMP experience
- Ability to work in fast pace environment
- Lab or pilot plant experience
Ideal candidate has solid manufacturing experience coming into the role (specifically being the "end user" in the manufacturing spectrum is great but not required)
- This role will be a hybrid role. We can provide some flexibility for WFH, but working on-site as projects need is expected. Some weeks may be completely WFH, but some may require every day on-site work.
Day to Day:
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.
- 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 our 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
- Master degree
- Bachelor degree and 2 years of experience
- Associate degree and 6 years of experience
- High school diploma / GED and 8 years of experience
- 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. 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