Skip to content
Process Development Sr. Associate
| Company | Amgen |
|---|
| Location | Thousand Oaks, CA, USA |
|---|
| Salary | $85306 – $103484 |
|---|
| Type | Full-Time |
|---|
| Degrees | Master’s |
|---|
| Experience Level | Mid Level, Senior |
|---|
Requirements
- Master’s degree
- Bachelor’s degree and 2 years of scientific experience
- Associate’s degree and 4 years of scientific experience
- High school diploma / GED and 6 years of scientific experience
Responsibilities
- Plan, design, execute, and document laboratory studies related to formulation and fill/finish process development in support of product commercialization and life cycle management
- Work independently, taking ownership of projects and self-managing work packages with appropriate communication and partner concern
- Apply basic science/engineering skills and first principle modeling to solve technical problems
- Participate in Drug Product Commercialization Teams responsible for conducting process development on pipeline products, as well as, supporting commercial products in lifecycle management
- Perform data analysis using advanced statistical/analytical techniques with a proficiency in statistical analysis software
- Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements
- Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions
- Deliver progress reports and presentations to ensure management awareness and engagement of the current status, advancement, and future program functional needs
- Ability to travel domestically and internationally up to 10% of the time
Preferred Qualifications
- Advanced degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Pharmaceutics or related subject area or Statistics degree with experience in pharmaceutical development and manufacturing
- 2+ years of post-doctoral or experience in pharmaceuticals/biotechnology industry or related field
- Experience with unit operation (i.e. filling, filtration, mixing, etc.) specific scale down model development, characterization, and scale-up
- Strong problem solving and effective cross-functional communication abilities
- Experience with coding/scripting for automated data analysis and modeling
- Experience with data visualization tools or packages, such as Tableau or Spotfire
- Experience that includes elements of new product development, formulation development, process characterization, equipment design and implementation, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments
- Ability to learn and act on dynamic information at a rapid pace
