SystImmune ยท 3 days ago
Scientist/Sr. Scientist
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Responsibilities
Participate in the development, optimization, and validation of bioanalytical methods for large molecule therapeutics and GMP comparability studies using LC-MS assays.
Follow established protocols for sample management, sample preparation, sample analysis, and data processing.
Provide high-level analysis of experimental results, troubleshoot, and interpret data.
Prepare SOPs and IND documents, maintain records to industry standards.
Responsible for instrument operation, maintenance, and troubleshooting.
Work on multiple projects within timelines, respond quickly to shifting priorities.
Document, analyze, interpret, and present reports and results 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.
Provide technical/scientific guidance and training to team members and research associates.
Prioritize work with minimum direction, perform detailed laboratory experiments.
Collaborate with multiple groups on technical projects, exhibit self-initiative and drive for results.
Qualification
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Required
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 QTOFLC-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.
Preferred
Industry laboratory experience and bioanalysis training is preferred.
Experience with H/UPLC methods (SEC, IEX, HILIC, RP), CE-SDS, cIEF, is a plus
Extensive hands-on experience with high-resolution mass spectrometry platforms, particularly Waters G2 XS XEVO MS, and proficiency with UNIFI software for data acquisition and analysis.
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
Ph.D. in Chemistry, Biochemistry, or related field with a focus on mass spectrometry.
Successful candidates would have 3-5 years of relevant industry experience, although exceptional candidates with less experience may be considered.
Benefits
100% paid employee premiums for medical/dental/vision
STD
LTD
401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years
15 PTO days per year
Sick leave
11 paid holidays
Company
SystImmune
SystImmune is a biotechnology company.
H1B Sponsorship
SystImmune has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2022 (3)
2021 (1)
2020 (2)
Funding
Current Stage
Early StageRecent News
2024-05-27
BioWorld MedTech
2024-05-24
2024-04-22
Company data provided by crunchbase