Sr. Associate Scientist/Scientist Mass Spectrometry
SystImmune is seeking an experienced and energetic person with hands-on LC/MS experience and proven abilities in characterizing antibodies and multi-specifics proteins. The Sr Associate Scientist/Scientist will be a part of a multidisciplinary team with capabilities in molecular engineering, cell line development and purification of large molecule therapeutics and is expected to design, evaluate, and complete analytical development projects consistent with company goals. This individual will be responsible for timely planning and coordination of regulatory submissions and will work closely with research and development associates to provide detailed characterization to enable robust protein production and formulation development.
- Participate in the development, optimization, and validation of bioanalytical methods for large molecule therapeutics and GMP comparability studies using LC-MS assays.
- ollow established protocols for sample management, sample preparation, sample analysis, and data processing.
- Provide high level analysis of experimental results, shows a deep understanding of developing assays methods, troubleshooting, and data interpretation.
- Prepare SOPs and IND documents as needed.
- Responsible for day to day instrument operation, routine instrument maintenance and troubleshooting.
- Work on multiple projects within timelines according to high scientific and ethical standards. Able to respond quickly to shifting priorities.
- Document, analyze, interpret, and present reports and results at various meetings, both internally and externally.
- Manage analytical transfer activities between Process development and QC lab.
- Plan time to accommodate meetings and technical support with team members in China during operating hours in China.
- Expertise in characterization of candidate biological drugs by peptide mapping, post-translational modification assignment, glycan characterization, disulfide mapping, intact and subunit mass analysis, focusing on antibodies and fusion proteins.
- Knowledge of sample preparation, and the fundamentals of chromatography and mass spectrometry are needed as the candidate is expected to identify assay issues and perform the associated troubleshooting.
- Maintain accurate records and write SOP, analytical and IND reports for FDA submission
- Hands on experience in operation, maintenance & trouble shooting of Waters QTOF LC-MS instrument and associated software.
- Provide technical/scientific guidance and training to team members and research associates
- The candidate must be able to prioritize his/her own work with minimum direction from supervisor.
- Excellent technical and problem-solving skills and ability to perform detailed laboratory experiments.
- Ability to work collaboratively with multiple groups on technical projects exhibiting self-initiative and drive for results.
- Proven record of being a fast learner, flexible, excellent communicator and mindful team member.
- Strong technical competency, well organized, good record keeping, excellent oral and written communication skills.
- Industry laboratory experience and bioanalysis training is preferred.
- Experience with H/UPLC methods (SEC, IEX, HILIC, RP), CE-SDS, cIEF, is a plus
- Experience with complex Glycoproteins and MS characterization methods
- Understanding of FDA regulations for submitting INDs. Knowledge/experience with regulatory requirements is desirable.
- Generate and analyzes data produced from a wide variety of analytical techniques and analytic instrumentation
Education & Experience:
Education Required: PhD + 0-2 years’ experience in Chemistry, Biochemistry or related field