The successful candidate will join a group to develop, qualify and perform analytical method characterization, product characterization and comparability activities for late-stage clinical and commercial recombinant protein pharmaceuticals, both drug substance and drug product.

Duties involve collaborating with other scientists in a multidisciplinary, multi-site team to execute the full scope of analytical methods for in-process testing, lot release, stability, comparability and protein structure characterization, while ensuring timely completion of notebook entries, and reports. This position will also have an emphasis of mass spectrometric method applications for product characterization, including primary structure / glycan structure elucidation, process characterization and product testing. Other duties include data analyses and testing against acceptance criteria in support of process development, process/method transfers, and comparability studies.

Additional responsibilities include providing regular updates, documentation, and communication of project results as appropriate, participating in national scientific meetings, and 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 evaluation, and monitoring and analyzing competitive scientific knowledge from external sources.

Basic Qualifications
Master’s degree & 2 years of Scientific experience OR Bachelor’s degree & 4 years of Scientific experience

Preferred Qualifications
– M.S. in biological sciences, biochemistry, physical sciences, chemical engineering
– Expertise with mass spectrometry of proteins, peptides and glycans.
– Expertise with statistical software is recommended
– 3 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.
– Troubleshooting skills