Scientist - Attribute Sciences - Puerto Rico
This role will conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor. Under general guidance of supervisor,
Conceives and designs, executes or evaluates, and interprets experimental strategies
Provides input to new processes to generate robust and reliable data
Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations
SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
Designs, monitors or conducts experimental strategies with general guidance from supervisor.
Development, improvement, troubleshooting, and execution of a broad panel of methods used in the analysis of recombinant protein drug substances and/or drug products.
Provides data analysis and interpretation, and assesses impact of the data on projects.
Defines project timelines and delivery against deadlines.
Keeps current in field of scientific expertise and areas relevant to their function.
Monitors field of expertise, including literature and technology development, and communicates relevant observations
May introduce advanced scientific methods.
Develops and implements new and novel protocols to address specific issues.
Collaboration with cross-functional groups, including Attribute Sciences, Quality Control, Process Development, and Manufacturing.
May represent the department on project teams under supervision of a senior scientific staff member.
May initiate productive collaborations within and outside of the department or company.
Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies.
Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents.
Participates in external scientific community.
May assume lead role in department-wide support efforts such as safety, recruiting and committees.
May develop supervisory and mentoring skills.
Develops and follows timelines for completing project team work.
Motivate and/or supervise the activities of others.
Be flexible to support extended hour, non-standard shifts and manage changes.
Master’s degree and 3 years of scientific experience
Bachelor’s degree and 5 years of scientific experience
Education discipline/background in Life Sciences and/or Engineering.
Demonstrated history of method development in the biotechnology field with a focus on late stage development and analytical characterization.
Extensive experience with LC/MS and LC/MS/MS analysis of recombinant protein therapeutics.
Advanced scientific analysis, troubleshooting and laboratory work skills.
Broad skill set in the separations sciences (HPLC, UHPLC, CE, iCE), including:Size Exclusion Chromatography (SEC)
Ion Exchange Chromatography (IEX)
Reversed-phase Chromatography (RP)
Strong knowledge of cGMP’s.
Be well organized, have multi-task project experience, and be able to communicate and work well with other departments.
Skills in the following areas:Fluent verbal communication
Written communication including technical writing skills, negotiation and conflict resolution
Analytical problem solving
Computer literacy (Windows environment: Word, Excel, Power Point)
Application of scientific theory
Skills in the design and performance of scientific experiments and interpretation of results.
Fully bilingual (English/Spanish).
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.