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 Scientist/Senior 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.
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, shows a deep understanding of developing assays methods, troubleshooting, and data interpretation.
Prepare SOPs and IND documents as needed, maintain records to industry standards.
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.
Required Qualifications:
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 Qualifications:
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
Education & Experience:
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.
The hiring pay range for this position is $100,000 - $150,000 per year based on skills, education, and experience relevant to the role.
SystImmune is a stable, well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 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, plus 11 paid holidays and MORE.
SystImmune is an Equal Opportunity Employer. Interested applicants should send their CV and cover letter to hr@systimmune.com