Scientist - Tech Transfer
This job posting is no longer active.
Location: Hazelwood, MO, United States
Position Type: Unfixed Term
Job Function: Bioscience R&D
A world leader in the field of in vitro diagnostics for more than 60 years, bioMérieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety.
In North America we have more than 6,200 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada.
Come and join a family-owned global company with a long-term vision, and a human-centered culture.
Description
Position Summary:
The Industrialization department at bioMerieux is seeking a Scientist to lead transfer of drug development into manufacturing. The scientist performs process validations and provides development support which includes data review, perform experiments, and risk assessments. This individual job function would be to provide technical knowledge of manufacturing needs and support project team.
Primary Responsibilities:
- Serve as manufacturing SME to support transfer of AST development.
- Design, execute, & present reports on experiments, qualifications, and validations. Present results to cross functional team &/or upper management.
- Provide technical expertise to projects related to scaling up and/or automating production process to meet market demands and ensure the appropriate manufacturing parameters are evaluated.
- Conduct design transfer readiness reviews and manufacturing readiness reviews as part of the product development process.
- Lead Industrialization risk analysis for the project and ensure the VITEK process risk analysis is updated prior to release of the antimicrobial test into manufacturing. This task involves understanding the manufacturing environment and the details associated with implementing a new manufacturing process.
- This person is expected to work in a team environment to execute validations and to support and troubleshoot issues that may arise in Industrialization to support the manufacturing area.
Education, Skills, & Experience:
- B.S. with 3+ years experience with process validation of manufacturing processes in a regulated environment or M.S. with 1+ year experience in validation of manufacturing processes in a regulated environment.
- Preferred degree in medical technology, biochemistry, or microbiology.
- Validation experience - Validation experience includes but not limited to risk/CQA evaluation, data analysis, & technical writing
- Strong problem-solving ability.
- Proficient computer skills including but not limited to MS Excel, MS Word, MS Project.
- Knowledge and/or work experience with regulatory agency (eg FDA, ISO) requirements.
- Must possess interpersonal skills to work as a team or individual contributor. Must work in a structured & organized manner to delivery on given tasks while having multiple projects timelines.
- Experience in a manufacturing environment and manufacturing systems (MES or ERP system). In particular, a device regulated manufacturing facility desired
- Statistics knowledge and working knowledge of statistical software packages (eg Minitab, Sigma Stat) desired.
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Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [email protected].
BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. 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 BioMérieux’s or its affiliates’ 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).
