We have an exciting opportunity for an experienced Senior Assay Developer to support several cutting-edge research & development programs currently underway at StarFish Medical. Our areas of focus require an advanced knowledge of potential biological markers of digestive tract disease states (including IBS, SIBO, and cancer). The primary products are medical devices developed under ISO 13485. This role is within our Product Development department, reporting to the BioTec Manager.
Ideal candidates will possess an advanced degree, be an expert in assay development (Homogenous assay experience a plus) and preference will be given to those who have familiarly with GI diseases (IBD, IBS, CRC, Gastric Cancer, Liver and pancreatic diseases). The candidate requires good knowledge of biochemistry, physiology, basic microbiology/cell culture laboratory skills, along with a good understanding of Design for Manufacturing and Assembly.
- Develop, troubleshoot and validate Immunoassays
- Analyze and summarize data from research and laboratory findings
- Write development and validation reports, protocol generation and SOPs
- Support project teams through assistance in BSL2 laboratory work (performed at the University of Victoria)
- Practice clear documentation techniques
- Conduct research into a variety of materials (plastics, biochemistries, biological interactions, etc.) and biomedical areas (general microbiology, biochemistry, physiology, etc.)
- Identify capable suppliers and vendors to purchase and expedite the delivery of key biological components or reagents
- Work with manufacturing personnel to develop assembly procedures for mechanical/electrical/biochemical assemblies related to biological considerations
- Assist with training and supervision of projects students
- Any other related duties, as required
- Advanced Degree in Chemistry, Biochemistry, or related field.
- 5+ years’ experience in the development and/or validation of LOCI and/or ELISAs and/or LFI assays for protein biopharmaceuticals in a regulated environment under Good Laboratory Practices (GLP)
- Lab analysis techniques including HPLC, ELISAs, cell culture, molecular biology techniques (qPCR), flow cytometry and immunocytochemistry
- Superior organizational skills demonstrated in scientific development work and/or clinical trial planning and monitoring
- Basic Biosafety Level 2 laboratory skills
- Demonstrated ability to work effectively as part of a team and in a multi-site/multicultural organization where effective multi-tasking and both intra and cross-program communication is essential for efficient mission accomplishment.
- Demonstrated ability to work as an individual with minimal supervision
- Strong technical writing and oral presentation skills
- Basic to intermediate MS Office Skills (Outlook, Word, Excel, etc.)
- Demonstrated knowledge and understanding of product development processes, preferably in biologics, regulatory pathways for medical devices and biologics (e.g. FDA, EMA), and knowledge of cGLP and cGMP
- 1 or more years’ experience clinical trials experience
- Knowledge of GCP, ICH, and other Guidance documents and policies related to clinical trials operations
- Experience working in a high tech environment
Posted: September 22, 2016
Closes:November 21, 2016