- Doctoral Degree
- Bachelor's Degree
- Master's Degree
- Clinical Trials
- Western Blot
- Heavy Lifting
- Manufacturing Experience
World leader in the field of in vitro diagnostics for over 50 years, bioMérieux 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.
bioMérieux is present in over 150 countries through 43 subsidiaries and a large network of distributors. More than 90% of our sales are done internationally. Its corporate headquarters are located in Marcy l’Etoile, near Lyon, in France.
Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture.
We look for candidates whose motivation is to invest in themselves, in the projects of the future, and to participate in a collective adventure led by a pioneering spirit.
We have the commitment to offer our collaborators a working environment which encourages team spirit, with priority given to training and development with international career opportunities.
Astute Medical, Inc. is an in-vitro diagnostics company dedicated to improving the diagnosis of high-risk medical conditions through the identification and validation of protein biomarkers that can serve as the basis for novel in-vitro diagnostic tests. To support the commercialization of its novel biomarker products, Astute Medical is seeking an energetic, self-motivated individual who can fill the role of Scientist, Product Development.
The Scientist supports technical development design verification/validation of quantitate immunoassays for novel protein biomarkers as well as provide technical support for product manufacturing transfer.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Independently conduct all aspects of experiments aimed at developing, optimizing, verifying / validating lateral flow immunoassay reagents, including study planning, recording observations, analyzing data, and interpreting results.
Independently draft, plan, and execute design verification protocol and reports
Provide technical support for design validation activities including clinical trials, in-house trials, data analysis and report writing.
Participate in cross-functional teams to complete design controls documentation and ensure smooth product development.
Provide hands-on support in the transfer of methods, specifications, and related technical information to manufacturers / suppliers, including establishing, documenting, and / or verifying / validating the following:
Product / process specification
Device master record
Critical raw materials
Manufacturing Equipment / Facilities
IQ / OQ / PQ activities
Present data, conclusions, technical plans / progress (both verbally and in writing) to all levels within the company and externally as required Support quality initiatives to maintain an environment of continuous improvement throughout the organization.
Ensure compliance with Company’s Quality Management System and ensures that all individuals reporting to him/her comply with the Company’s Quality Management System
PhD in the physical sciences, life sciences, or engineering disciplines (physics, chemistry, chemical / biochemical engineering, biochemistry, or biology) with 2-5 years of relevant experience. MS or BS degree with 5+ years of relevant experience will also be considered.
Familiarity in working within ISO 13485 environment.
Track record of success developing quantitative immunoassays on point-of-care or other complex immunoassay systems for in-vitro diagnostic (IVD) products.
Working experience with product development, product transfer, manufacturing scale-up, quality control procedures, design verification/validation and controlled documentation processes.
Proficiency with standard laboratory techniques including: ELISA, gel electrophoresis, western blotting, protein purification methods, and liquid chromatography methods.
Expertise in protein conjugation chemistry both in solution and on micro / nano particles with fluorescent labels / materials preferred.
Superior attention to detail.
Proficiency with data analysis using MS Excel or equivalent tools.
Su perior critical thinking skills.
Excellent organizational, record keeping and communication skills.
A strong work ethic to generate high quality data under tight deadlines.
While performing the duties the employee is:
Constantly required to reach computers and other office and laboratory equipment
Constantly required to view objects at close and distant ranges
Frequently required to communicate with others
Frequently required to sit
Frequently required to stand
Frequently required to use fine manipulation and simple grasping in order to handle laboratory equipment and to utilize the computer and other standard office equipment such as telephone, fax machines, copiers, etc.
Frequently required to lift and transport items weighing up to 25 lbs.
May occasionally be required to travel to meetings and tradeshows
Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.
Employee frequently works in an office environment with a moderate amount of noise and activity. The work environment is fast-paced and demanding. Workweeks exceeding 40 hours are required as necessary.
bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity
: AMER-AMER-US-CA-San Diego, CA
: Jun 13, 2019, 2:37:37 PM
: Day Job
: Yes, 10 % of the Time