Amgen

Scientist, Pre-pivotal Bioprocess Development

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Apr 25, 2019
Ref
R-75227
Required Education
Doctorate/PHD/MD
Position Type
Full time
Amgen is seeking a Process Development Scientist within our Pre-Pivotal Bioprocess Development team, to be based in our Thousand Oaks, CA office.

You will lead laboratory-focused projects, collaborating with cell culture and purification scientists who develop robust clinical processes to advance Amgen's biologics pipeline. As part of this opportunity, you will develop strong technical skills, cross-functional teams, and mentor junior staff in career development. The scope of work and responsibility span protein construct selection, clinical process development, support of technology transfer, authoring regulatory CMC documents, and interacting with regulatory agencies. In addition, you will lead and support efforts to develop and implement new technologies and new business strategies to drive organizational efficiency. This 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.

Basic Qualifications:
Doctorate degree
OR
Master's degree and 4 years of experience contributing to and/or participating in scientific project teams
OR
Bachelor's degree and 6 years of experience contributing to and/or participating in scientific project teams
OR
Associate's degree and 8 years of experience contributing to and/or participating in scientific project teams
OR
High school diploma / GED and 10 years of experience contributing to and/or participating in scientific project teams

Responsibilities for the Process Development Scientist include:
• Independently authors technical reports, regulatory filings, patents, peer reviewed publications and actively participates in scientific conferences
• Conveys information and makes recommendations on scientific issues to senior management
• Develops technology to deliver multi-kilogram quantities of drug substance 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 authority and keeps current in relevant literature and related technology with a 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

Preferred Qualifications:
• Doctorate in biological science discipline or chemical engineering with 2+ years of experience
• Expertise and experience in mammalian cell culture and/or purification process development
• Extensive experience in development and/or support of bio-manufacturing processes, including process scale-up and GMP production
• Experience in CMC clinical and commercialization process
• Track record of innovation and implementation of new technologies
• Experience in authoring IND sections and interaction with regulatory agencies

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.