Biological Dynamics has an opening for a full-time Senior Scientist, Assay Development to design, execute, and interpret experimental results for assay development projects focused on nucleic acid diagnostics. This is a hands-on role, requiring an individual capable of designing new assays utilizing our proprietary detection technology as well as those based on established molecular diagnostic platforms such as PCR. Our ideal candidate must be comfortable with, and thrive in, an entrepreneurial environment which necessitates a hands-on approach at all levels.
The individual in this position will work within the Assay Development department across product development stages, from establishing the technical feasibility of an assay through analytical validation. The successful candidate will perform the development and validation of new assays on our proprietary detection technology platform and will also excel in the applying his/her skills to traditional molecular assays. The candidate must be able to efficiently design and execute experiments, perform data analysis, and communicate results and observations effectively.
Responsibilities and Duties:
Independently designs and executes experiments in support of development of a range of nucleic acid-based assays.
Designs, performs, and analyzes verification and validation (V&V) studies as part of analytical validation.
Analyzes data, interprets and presents results, provides creative solutions to problems, and designs troubleshooting experiments as needed.
Works closely with all other teams, including Research, Product Development, Quality, Regulatory Affairs, and Commercial Operations, as part of the new product development process.
Prepares and presents technical data, including issues, risks, and opportunities, to cross-functional audiences.
Drafts and reviews SOPs and other technical documents, as necessary.
Accurately produces all required assay development design control documentation following the quality management system (QMS).
Performs scientific literature searches, selects methodologies, and selects appropriate reagents for assay development.
Manages the ordering and preparation of required reagents.
Other projects as assigned.
PhD degree in molecular biology, biochemistry, or another life science field, or an equivalent combination of education and applicable work experience
3+ years of experience in molecular assay development in the life sciences industry
Experience in the development of IVDs or medical diagnostics highly preferred
Expertise in analytical validation, including studies to determine precision, reproducibility, limits, and other key assay parameters, is a plus
Skills in product development processes performed under design control
Strong general molecular biology skills
Working knowledge of the use of statistical analysis software such as JMP
Familiarity in working with hardware and software development teams is a plus
Expertise in oncology preferred
o Desire and drive to work in a fast-paced, hands-on entrepreneurial environment;
o Skilled at writing clear plans, reports and SOPs;
o Effective at planning, organizing, and prioritizing;
o Demonstrated sense of urgency to deliver high-quality results under tight timelines;
o High attention to detail and accuracy;
o Effective troubleshooting and problem-solving skills;
o Able to handle pressure and ambiguity and maintain composure and focus in situations of uncertainty;
o Adept at building strong relationships and collaborating with colleagues at all levels;
o Highly collaborative, self-motivated, and team-oriented;
o Effective communication skills, both verbal and written; and
o Strong interpersonal skills and ability to work effectively across multiple multidisciplinary teams
Biological Dynamics is an equal opportunity employer.