We are searching 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 infectious disease diagnostics, and potential biological markers of digestive tract disease states (including IBS, SIBO, and cancer). Our leading-edge products include medical devices developed under ISO 13485.
Ideal candidates will possess a PhD, and will be an expert in assay development (Homogenous assay experience a plus). Along with a sound foundation in biochemistry, physiology, basic microbiology/cell culture laboratory skills, this position will be relied upon to interface with electrical and mechanical engineering to help design products for manufacturing and assembly.
Do you consider yourself intellectually curious, self-directed, and a proven problem solver? Do you have experience bridging the gap to product development, and utilizing your ability to work with (i.e. speak the language of) electrical and mechanical engineers in order to make innovative and creative medical devices? If so, we have fascinating projects in process and would love to hear from you!
ABOUT STARFISH MEDICAL
StarFish Medical is Canada’s premier medical device development group, an integrated team of 80+ technical product development professionals who work on device design projects for North American and international customers. Our head office is located in beautiful Victoria, British Columbia and we have recently expanded to Toronto, Ontario based on our business growth and success.
You will work with some of the best medical device design strategists, designers and engineers and help direct, create and deliver exciting product experiences for varied device markets. Our project areas range from tactical EMS products, surgical tools and consumer diagnostic devices through to high volume disposables, complex IVD systems, imaging technologies and lab equipment.
StarFish offers a collegial, creative and casual working environment. In a recent survey, our employees rated: peers and culture, interesting and meaningful work, and working conditions (flexibility, environment) as the top reasons they most enjoyed working at StarFish.
Reporting to our BioTech Manager and working within our Product Development Department, this position will focus on the following responsibilities:
- 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 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 engineering and 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 (PhD or medical degree preferred)
- 8-10 years’ experience in the development and/or validation of LOCI and/or LFI assays for protein biopharmaceuticals in a regulated environment under Good Laboratory Practices (GLP)
- Lab analysis techniques including HPLC, 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
HOW TO APPLY
Qualified applicants are encouraged to apply in confidence to email@example.com with a covering letter, resume and salary expectations that clearly indicates which position you wish to be considered for, and describes exactly how your education and experience meet each of the requirements of this position.
We thank all applicants who apply; however only those selected for consideration will be contacted.