Manager, Scientist I
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The Scientist 1’s primary responsibility is to develop and lead studies that demonstrate an in vitro diagnostic (IVD) product meets the regulatory requirements. Specifically, the Scientist 1, under the supervision of the Associate Director of Clinical Affairs, is responsible for planning, designing, overseeing, and writing study reports for studies within the Clinical Affairs team that will be used to support the regulatory submissions. The studies may be conducted at BioFire or by external contractors.Essential Job Duties and Responsibilities
- Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
- Maintain current knowledge of FDA requirements for clinical studies and FDA expectations for establishing clinical performance of diagnostic products.
- Contribute to pre-submission documents for FDA feedback on clinical study plans.
- Develops plans for validation (study protocols) of in vitro diagnostic (IVD) reagent test kits under supervision of the Director of Clinical Affairs
- Collaborates with R&D scientists in the development and validation and new assays for use a comparator methods for clinical studies; responsible for scale-up of the assays into high-throughput workflows.
- Ensures specimen traceability and audits trails for all testing.
- Collaborates with the Postmarket Surveillance team in investigation and analysis of postmarket data.
- May supervise research associates in performance of laboratory work, documentation, maintenance of specimen and organism databases and associated activities.
- Oversees the performance of study protocols and data evaluation to ensure that the study is conducted according to the protocol and to identify technical issues.
- Writes study reports that will be used to support regulatory submissions.
- Maintains broad knowledge of state-of-the-art principles and theories.
- Makes contributions to literature and conferences as well as grant/proposal writing and patent applications, as needed.
- Advises management about scientific issues related to studies in support of regulatory submissions.
- Collaborates with other scientists and personnel in various company departments to resolve technical issues.
- Uses professional concepts to contribute to the development of company concepts and principles and to achieve objectives in creative and effective ways.
- Ensures that laboratory notebooks and study paperwork (as applicable) for assigned projects/experiments are maintained in accordance with BioFire’s Employment Handbook.
- Participates in writing of final regulatory documents (e.g. 510K Pre-Market Submission to US FDA)
- Maintains current knowledge of IHC/Good Clinical Practices, as well as international regulations and expectations for clinical performance evaluations as needed.
- Maintains current knowledge of General Data Protection Regulation (GDPR) and In Vitro Diagnostic Medical Device Regulation (IVDR).
- Maintains current Human Subjects Protections training through an accredited program (e.g. CITI).
1. This position requires excellent written and oral communication skills.
2. Excellent interpersonal skills and the ability work with a wide variety of people (physicians, laboratory directors, laboratory staff, etc) involved in conducting the clinical studies.
3. The ability to work closely with Associate Director of Clinical Affairs to identify and communicate areas of technical, schedule, and budget.
4. Excellent organizational skills are essential.
Training and Education:
Requires a PhD in scientific discipline or equivalent; may also include exceptional non-PhDs with demonstrated capabilities.
PhD with no additional experience or master’s with at least 5 years of experience. Postdoc or prior industry experience preferred.
Knowledge, Skills, and Abilities:
Strong written and oral communication skills. Basic statistical techniques.
May be required to lift 30 lbs.
Regular and consistent attendance
BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioFire Diagnostics’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).