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Senior Scientist - United States  

Company managed [?] Still accepting applications

Posted on : 26 September 2017

Project Description

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. Amgen Pharmacokinetics and Drug Metabolism (PKDM) is currently seeking a Senior Scientist with bioanalytical expertise who will be responsible for assay development, validation and GxP use of binding and neutralizing antibody assays for monitoring immunogenicity. The Senior Scientist will also have an opportunity to contribute to bioanalytical efforts for pharmacokinetic assays for biological therapeutics. The role reports to the Director, PKDM who heads the immunogenicity bioanalytical group in Thousand Oaks, CA.
The primary responsibilities include:
Drive innovative science for immunogenicity and pharmacokinetic measurement (PK) assays with emphasis on former, independently monitor or conduct experiments and studies, to advance projects or technologies.
Guide and supervise the development and validation of immunogenicity assays for the detection of binding and neutralizing antibodies.
Provide guidance for the successful transfer of immunogenicity assays to CROs.
Participate in onsite regulatory inspections.
Provide advanced immunogenicity data analysis and interpretation, and assess impact of data on the project and make recommendations.
Identify relevant external competitive knowledge.
Independently prepare new and novel bioanalytical assay protocols/experimental design.
Function as a key contributor to an independent research/project team.
Initiate productive collaborations outside of the department or company.
Introduce new or advanced bioanalytical assay technologies and/or concepts.
Contribute to scientific journal articles or complex technical documents as lead author.
Lead department-wide support efforts.
Develop or utilize supervisory and mentoring skills.
Make proactive decisions that contribute to the achievement of milestones.
Plan detailed procedures for defined projects, including timelines, milestones,methodological approaches, expected results and necessary resources.


Basic Qualifications:

Doctorate degree and 2 years of pharmaceutical-biotechnology and/or CRO industry experience
OR
Master’s degree and 5 years of pharmaceutical-biotechnology and/or CRO industry experience
OR
Bachelor’s degree and 7 years of pharmaceutical-biotechnology and/or CRO industry experience

Preferred Qualifications:

Ph.D and 5 years of pharmaceutical-biotechnology and/or CRO industry experience
Knowledge and experience in method development and validation of immunogenicity and large molecule (PK) assays for GxP use, experience with assay transfer to CROs, authoring of method-related sections in regulatory documents
Prior supervisory experience and excellent written and oral presentation skills
Ability to work in a team environment and to identify solutions for complex technical bioanalytical challenges
High degree of proficiency in immunogenicity based bioanalytical sciences
Demonstrated ability in understanding regulatory requirements for bioanalysis of biological therapeutics
Knowledge of cell-based assays for NAb detection
Experience in contributing to external sourcing efforts associated with transfer of bioanalytical methodology
Demonstrated ability in understanding regulatory requirements for bioanalysis of biological therapeutics

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.