Process Development Senior Scientist

Scientific leadership of analytical and biochemical characterization activities for pre-clinical biotherapeutic protein development, including: assay development, planning and execution in support of pre-clinical candidate selection, process development and lead molecule characterization.

Specific activities will include characterizing candidate molecules to support protein primary structure for drug substance and drug product, as well as characterizing candidate attributes and their susceptibility to modification during process and product development activities. This includes the use of mass spectrometry coupled with a variety of separation techniques, including liquid chromatography (reversed-phase, size-exclusion, cation-exchange) and capillary zone electrophoresis to identify, characterize, and quantitate quality attributes.

In addition, there will be a focus on developing sample preparation and MS-based technologies to reduce time and material requirements during all phases of candidate selection. This role will also emphasize mass spectrometric method development and application for product characterization, including primary structure / glycan structure elucidation, determination of product purity profiles, product attribute criticality and target product profiles (TPP). Generation of technical documents and technical presentations is required.

Other duties include working as part of a multi-functional team to define strategies for protein mass spectrometry testing, performing sophisticated data analyses, and developing high efficiency strategies to monitor attributes supporting the quality target product profile (qTPP). Requires the ability to work collaboratively with other scientists on multidisciplinary teams.

Additional responsibilities include keeping current with field of expertise, including literature and technology development. This position is also responsible for providing scientific results that support the generation of publications, patents and regulatory submissions, participating in recruiting and candidate review, exploring and evaluating new technologies relevant to MS-based characterization of therapeutic proteins, and monitoring and analyzing competitive scientific knowledge from external sources.

Basic Qualifications

Doctorate degree and 2 years of experience

OR

Masters degree and 5 years of experience

OR

Bachelors degree and 7 years of experience

Preferred Qualifications

• Ph.D. in biological sciences, biochemistry, pharmaceutical sciences, physical sciences, chemical engineering
• Expertise with mass spectrometry of proteins, peptides and glycans.
• Familiarity with Thermo mass spectrometers, Agilent and Waters LC systems, and corresponding data acquisition software such as Chromeleon and Empower.
• Familiarity with mass spectrometry data processing software (BioPharma Finder, Byonic, Byos, Expressionist, Pinpoint, Skyline)
• Expertise with statistical software is recommended
• 5 years of scientific experience within the biotech industry, experience to include data analyses, statistical analysis, setting acceptance criteria in support of process development, process/method transfers, and comparability studies.
• Good problem solving skills requiring the application of scientific theory
• Ability to demonstrate skills in independently determining and developing scientific analysis and solutions, as well as demonstrate strong laboratory work skills to include the design and performance of scientific experiments and interpretation of results.
• Excellent written and oral communication skills for the timely documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary environment.

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If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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