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Manager, Scientist II
$127k-161k (estimate)
Full Time | Scientific Services
3 Months Ago
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bioMérieux is Hiring a Manager, Scientist II Near Salt Lake, UT
Job Summary
The Scientist 2’s primary responsibility is to develop and lead studies that demonstrate an in vitro diagnostic (IVD) product meets the regulatory requirements. Specifically, the Scientist 2, with general guidance of the 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.
- Supervises 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).Supplemental Data
- This position requires excellent written and oral communication skills.
- The ability to work closely with Director of Clinical Affairs to identify and communicate areas of technical, schedule, and budget risk.
- Excellent organizational skills are essential.
- Domestic and international travel required – up to 5%
Qualifications
Training and Education
Requires a PhD in scientific discipline or equivalent; may also include exceptional non-PhDs with demonstrated capabilities.
Experience
PhD with 3-5 years of relevant experience. MS with at least 8 years for relevant experience.
Knowledge, Skills and Abilities
Strong written and oral communication skills. Basic statistical techniques.
Physical Requirements
May be required to lift 30 lbs.
Regular and consistent attendance
Job Summary
JOB TYPE
Full Time
INDUSTRY
Scientific Services
SALARY
$127k-161k (estimate)
POST DATE
02/17/2024
EXPIRATION DATE
05/13/2024
WEBSITE
www.biomerieux.com
HEADQUARTERS
Rio de Janeiro - RJ
SIZE
7,500 - 15,000
CEO
Kaitlyn Larrabee
INDUSTRY
Scientific Services
Related Companies
About bioMérieux
bioMrieux conceives, develops, produces and markets diagnostics solutions (systems, reagents, software and services) intended for clinical and industrial applications, which determine the origin of a disease or a contamination to improve the health of patients and insure consumer safety. The company headquarters is located in Marcy-l'toile, Auvergne-Rhne-Alpes.
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