Alentic Microscience Inc. requires a career-oriented Biochemical Assay Development Specialist to be responsible for developing novel optical assays of physiologically significant ions, metabolites, peptides, proteins and other constituents of blood and other biological fluids, for use in point of care in vitro diagnostics. The Biochemical Assay developer will contribute to assay strategy, and be responsible for methodology development including design and performance of experimental tests, compiling and analyzing test data and writing final reports. The incumbent must also maintain familiarity with current cGMP regulations and scientific literature, as well as contribute to documentation of design history and development of Quality Control for the assays.
- Coordinate and ensure the successful completion of assigned projects, including compiling test data and writing final reports.
- Conduct data reviews of analysis samples to determine their acceptability.
- Develop, design, and write assay and equipment validations.
- Write and revise standard operating procedures (SOPs) for assays, products, procedures, and equipment for managerial review and approval.
- Analyze test results to verify meeting of all specifications.
- Write technical reports and perform data analysis and trending for both method development and investigations.
- Troubleshoot equipment when necessary.
- Train and educate less experienced analysts on basic and complex test methods.
- Interact with inspectors and provide technical guidance during lab tours.
- Conduct peer reviews of data gathered from method development and validation activities.
- Review technical problems, create solutions, and forecast major problems for key operations.
- Assist with and perform internal audits if required.
- Perform other tasks relevant to the position as necessary.
- Advanced degree in biochemistry, pharmacology, chemical sciences, or related discipline.
- Track record of successful design and implementation of novel biochemical assays for optical readout.
- Working experience in biomedical industry is highly desirable, preferably with at least 3 years’ experience in biomedical, med tech or pharmaceutical cGLP or cGMP laboratory.
- Proficiency in biochemical, chemical and cell biological analytical methods including quantitative fluorescence microscopy, ELISA, fluorescence immunoassay, PCR, next-gen DNA sequencing, UV-VIS Spectrometry, gel electrophoresis (SDS PAGE, nucleic acid, etc.), wet chemical analysis,
- Experience with nucleic acid, peptide and organic chemical synthesis is desirable, as is experience with aptamer and monoclonal antibody generation.
- Understanding of cGMP regulations as referenced in the Code of Federal Regulations (21CFR).
- Experience in interpreting and applying cGMPs, USP, regulatory requirements, and industry best practices.
- Demonstrated ability to lead a team, and to work both independently and collaboratively, to complete assignments within defined time constraints.
Alentic Microscience Inc. offers highly competitive salary packages, a hugely enjoyable and supportive work environment, and signifiant career advancement opportunities, in a dynamic, attractive, human-scale urban environment within minutes of magnificent unspoiled seacoasts, lakes and rivers.
Job Type: Full-time
- biomedical, med tech: 3 years