Amgen Process Development Principal Scientist in Thousand Oaks, California
Amgen is seeking a Process Development Principal Scientist in our Process Development team, to be based in our Thousand Oaks, CA headquarters. The Process Development Principal Scientist will report to the Director of Process Development and will support the Pivotal Drug Product Technologies team responsible for developing and commercializing robust formulations and processes for our small molecule pipeline.
The Principal Scientist will contribute to and lead cross-functional drug product development teams, drive technical strategy for small molecule programs, serve as the Formulation and Process technical lead, and be actively involved with other functional areas to provide technical expertise during the overall drug product commercialization process. The Incumbent will have a broad range of experience with formulation and process unit operations to guide teams and junior staff toward establishing robust control strategies for the manufacture of new drug products. A track record of creative problem solving using established and novel technology that impact processes and programs will distinguish the successful candidate. Further, the Principal Scientist must have excellent interpersonal and communication skills and demonstrated ability to work effectively in a global team environment.
Responsibilities for the Process Development Principal Scientist include:
Conveys information and makes recommendations on scientific issues to senior management
Effectively interfaces within the Drug Product Technology department and with external functions, such as Drug Substance, Attribute Sciences, CMC Lifecycle Management, Quality Assurance, Regulatory Affairs, Supply Chain, Contract Manufacturing, Clinical Development, etc. to advance the DP commercialization process
Executes experiments and interprets results to characterize commercial drug products
Serves as a technical expert and keeps current in literature, drug delivery technologies, and regulatory requirements (FDA, EMA, ICH, etc) to effectively and proactively mitigate potential program risks.
Works cross-functionally to author CMC regulatory documents and documentation in support of Amgen's regulatory filings, particularly MA and NDAs
Develops processes that can be scaled-up in a cGMP manufacturing environment at external contract manufacturing organizations.
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.
Independently authors technical reports, regulatory filings, patents, peer reviewed publications and actively participates in cutting edge scientific conferences
Participates in cross-functional initiatives to advance and enable Amgen long term goals
Ensures that safe working practices are followed in laboratories and pilot plants
Motivates, develops, and coaches staff while promoting team collaboration
Doctorate degree and 2 years of Process Development and/or contributing to and/or participating in scientific project teams experience
Master's degree and 6 years of Process Development and/or contributing to and/or participating in scientific project teams experience
Bachelor's degree and 8 years of Process Development and/or contributing to and/or participating in scientific project teams experience
Associate's degree and 10 years of Process Development and/or contributing to and/or participating in scientific project teams experience
High school diploma / GED and 12 years of Process Development and/or contributing to and/or participating in scientific project teams experience
PhD degree or equivalent in Pharmaceutical Sciences, Material Sciences, Chemistry, Chemical Engineering, or another relevant scientific field
Experience in DP scale-up and Process Performance Qualification
Experience interacting with Contract Research/Manufacturing Organizations to Technology Transfer DP to a commercial setting
Understanding of regulatory requirements for chemistry, manufacturing and controls (CMC) production including cGMP's and ICH guidelines
An external scientific track record of peer reviewed publications, scientific conference participation or participation in industry working groups or panels
In depth understanding at a fundamental level of multiple unit operations for the manufacture of oral solid dosage forms (i.e. granulation, roller compaction, drying, milling, blending, compression, etc.)
Demonstrated hands-on experience in formulation and process optimization by use of statistical designed experiments leading to a well-defined design space and robust control strategy
Demonstrated ability to be effective and fungible in a fast-paced team environment
Excellent interpersonal, presentation, written and verbal skills
Amgen 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.