External:
Job Information
Business Title
BioReagents Formulator
Department
Reagent Manufacturing
Cost Center
2802140_Mfg Reagents_FAFORM
Title of Direct Supervisor
Reagent Production Supervisor
Description of Responsibilities
Position Summary
This is a full-time non-exempt position.
Responsible for manufacturing products efficiently, accurately, safely and on time. Operates manufacturing equipment and in-process instrumentation to manufacture regulated products in accordance to QSRs, company policy and safety regulations. Works on assignments that are routine in nature where ability to recognize deviation from accepted practice is required. Position requires attention to detail and fine motor dexterity. Relies on instructions and pre-established guidelines to perform the functions of the job and requires direct supervision or oversight by a senior employee. Works under immediate supervision of the BFDX Formulation Team Lead and reports to the BFDX Reagent Production Supervisor.
Responsible for manufacturing and formulation of some BioReagents products and sub-assemblies including FilmArray. Weighs, measures, and checks raw materials to assure that manufactured batches, lots, buffers and sub-assemblies contain the proper reagents and qualities. Assists in complex functional testing and troubleshooting product, process material or formulation processes. Applicant must be mathematically competent, detail orientated, and able to follow written directions well. Familiar with a variety of the field’s concepts, practices, and procedures. A wide degree of organization and attention to detail is expected. Works with minimal instruction on routine work and Lead oversight/ instruction on new assignments.
Primary Duties
Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.Maintains records in compliance with regulatory requirements, current Good Manufacturing Practices, and Standard Operating Procedures.Relies on pre-established written guidelines to perform job functions.Operates Production EquipmentResponsible for wet and freeze-dried reagent formulations, sub-assemblies, and finished goods.Responsible for maintaining a clean environment of formulation labs and associated spaces.May assist with in-process testing to assure batches or lots meet specifications.Performs additional tasks as assigned by management.Works under immediate supervision of the BFDX Formulation Team Lead and reports to the BFDX Reagent Production Supervisor.Performs other duties as assigned.
Supplemental Data
None.
Qualifications
Training and Education
Minimum -Completed two years, or equivalent, of college coursework or 2+ years of work experience in an FDA/ISO regulated industry in lieu of education.
Preferred- Bachelor’s degree/4 year program with an emphasis on a biological science. 1+ years scientific/laboratory experience. 1+ years cGMP.
Check the highest-level education required (must be job-related). Identify the discipline, where applicable:
Bachelor’s Degree
Will work experience be accepted in lieu of a degree? Yes
If yes, number of years of experience accepted in lieu of degree and type: two years, or equivalent, of college coursework or 2+ years of work experience in an FDA/ISO regulated industry in lieu of education
Experience
Preferred - Experience pipetting/liquid handling, technical writing/reviewing, detail-oriented work. Software (Word, Excel, Web browser).
Knowledge, Skills, and Abilities
Proficient in math, specifically unit conversions. Good oral/written communication, pipetting/liquid handling of multiple volumes. Maintain attention to detail for extended periods of time. Execute repetitive tasks and maintain high level of consistency over time. Has knowledge of commonly used concepts, practices, and procedures including PCR, RT-PCR real-time PCR, and use of fluorescence based nucleic acid detection techniques.
Working Conditions and Physical Requirements
Check if applicable
Ability to remain in stationary position, often standing, for prolonged periods.
Ability to wear PPE correctly most of the day.
Ability to adjust or move objects up to 50 pounds in all directions.
Domestic travel required ____ % of time
International travel required ____ % of time
Able to safely lift and maneuver up to 50 lbs. Standing and/or sitting 2+ hours at time. Able to perform duties while wearing a Powered Air Purifying Respirator (PAPR).
Supervisory Responsibilities
N/A
Management Scope
Check appropriate decision-making authority below:
Decisions with long-term impact
With supervisory review/approval required
Decisions with short-term impact
With supervisory review/approval required
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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).