Amgen Process Development Senior Scientist in Thousand Oaks, California
Amgen is seeking a Process Development Senior Scientist within our Pre-Pivotal Bioprocess Development team, to be based in our Thousand Oaks, CA office. The Process Development Senior Scientist will report to the Pre-Pivotal Bioprocess Development Director.
The Senior Scientist will lead a laboratory-focused group of cell culture and purification scientists who develop robust clinical processes to advance Amgen’s biologics pipeline. As part of this opportunity, the Incumbent will develop strong teams and support staff in career development. The Senior Scientist will also provide leadership of cross-functional teams that deliver technology transfer enabling drug substance manufacturing processes. The scope of work and responsibility span clinical process development, support of technology transfer, authoring regulatory CMC documents, and interacting with regulatory agencies. In addition, the Incumbent will lead and support efforts to develop and implement new technologies and new business strategies to drive organizational efficiency.
The Pre-Pivotal Drug Substance Technologies organization develops, characterizes and supports the production of the drug substance manufacturing processes for all early-stage programs across the Amgen portfolio, enabling advancement of programs from pre-clinical through Ph I/II clinical trials.
Responsibilities for the Process Development Senior Scientist include:
Independently authors technical reports, regulatory filings, patents, peer reviewed publications and actively participates in cutting edge scientific conferences
Conveys information and makes recommendations on scientific issues to senior management
Develops technology to deliver multi-kilogram quantities of drug substance candidates in a safe, practical and efficient manner
Provides significant contributions to drug substance development teams (e.g., product, process development and product quality teams) by providing drug substance updates, documentation, data interpretation, technical recommendations, etc.
Serves as a technical expert and keeps current in relevant literature and related technology with a track record of successful application of said technology complying to current and emerging regulatory requirements (FDA, EMA, ICH, etc)
Works cross-functionally to author CMC regulatory documents and documentation in support of Amgen’s regulatory filings
Develops processes amenable to cGMP operation and leads deliveries of drug substance in a cGMP manufacturing environment in both internal and external capacity for batch and continuous processes
Ensures that safe laboratory practices are followed.
Provides mentoring and expertise to less-experienced staff
Achieves work in a matrix organization through others who may or may not report directly to them, internally or externally.
Motivates, develops, and coaches staff while promoting team collaboration
Doctorate degree and 2 years of experience contributing to and/or participating in scientific project teams
Master’s degree and 6 years of experience contributing to and/or participating in scientific project teams
Bachelor’s degree and 8 years of experience contributing to and/or participating in scientific project teams
Associate’s degree and 10 years of experience contributing to and/or participating in scientific project teams
High school diploma / GED and 12 years of experience contributing to and/or participating in scientific project teams
Doctorate in biological science discipline or chemical engineering with 5+ years of experience
Expertise and experience in mammalian cell culture and cell sciences
Extensive experience in development and/or support of biomanufacturing processes, including process scale-up and GMP production
Experience in CMC clinical and commercialization process
Leadership of a lab group or leadership experience of functional or cross-functional projectteams
Demonstrated results from leadership opportunities
Track record of innovation and implementation of new technologies
Experience in authoring IND sections and interaction with regulatory agenciesAmgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.