Senior Scientist

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Job description

Title: Sr. Scientist

Location: San Jose CA Hybrid

Duration: After 180 days converted into permanent

Us citizen or GC holder only

From Manager: I 'm looking for someone with IVD medical device experience with also a microbiology background (ideally antimicrobial susceptibility testing experience). Industry experience is more important than academic (experience in industry over PhD, for example).

Job Overview

The Sr. Scientist will be responsible for performing and documenting experiments that are part of the development, verification and product stability studies. You will be responsible for planning experiments, authoring documents, following protocols, analysing, and presenting results. You will work in cross-functional teams to ensure that the studies performed meet all necessary regulatory and quality standards for in vitro diagnostic (IVD) products. Candidates with a strong background in microbiology, susceptibility testing, and product development experience in a regulated environment are strongly encouraged to apply.

Primary Duties

Independently design and plan experiments and studies

Performs microbiological testing to support ongoing study protocols, and testing of new instruments, AST panels, and consumables.

Process biological specimen samples using aseptic techniques and following lab safety protocols.

Maintain thorough records of experiments and data in lab notebook or study data sheets or designated project folders and follow Good Documentation Practices (GDP). Maintain accurate and comprehensive records of all activities conducted in accordance with company policies and regulatory standards.

Work independently and as a member of a cross-functional teams to support microbiology research and development activities for assigned projects.

Analyse generated data and report on it in a timely manner. Experience with large data set analysis and visualization is desired.

Write protocols, SOPs, work instructions, and other feasibility and development documents such as plans and reports.

Prepares weekly reports and PowerPoint slides to summarize activities and accomplishments clearly and concisely. Present findings periodically at meetings.

Provide mentorship and guidance to junior scientists and laboratory staff, fostering a culture of continuous learning and skill development.

Investigate and assist in the troubleshooting of microbiological and system issues, deviations, and unexpected results

Participate in routine lab equipment and inventory maintenance as needed.

Handle and dispose of biohazard material in compliance with OSHA and biosafety procedures and maintain a clean lab environment.

Ensure compliance with all company policies and procedures and relevant regulations, including FDA, ISO 13485, and Quality and PDP procedures to ensure that all developed work products meet regulatory standards and safety requirements.

Perform other related duties as required.

The job requires knowledge and proficiency in standard microbiological methods such as dilution and enumeration of microorganisms, stocking frozen strains, isolation and identification of pathogenic microorganisms, preparation and sterilization of culture media, aseptic techniques, investigating components of culture media and impact on growth.

Knowledge and Skills

B.S. with 5+ years relevant experience or M.S. with 3+ years relevant experience in Microbiology, Biochemistry or equivalent and/ or Medical Diagnostic development experience is desired.

Experience working within a fast-paced environment with strong product development background and proven proficiency in data analysis, study design, troubleshooting system issues.

Experience in the development, verification and validation of clinical diagnostic and susceptibility assays for infectious disease desired.

Strong organizational skills, decision making, communication, teamwork, and troubleshooting skills.

Excellent written and verbal communication skills with the ability to present complex scientific concepts in a clear and concise manner.

Knowledge of aseptic techniques, good documentation practices (GDP), and good laboratory practices (GLP).

Minimum 3 years of laboratory bench experience preferably in a BSL2 environment, clinical microbiology laboratory experience is advantageous.

Proficiency using Microsoft Office applications (Word, Excel, PowerPoint)

Knowledge of ISO 9001 and FDA Quality System Regulations.

Must be able to work both independently with minimal guidance and oversight as well as in tandem with all levels of corporate personnel. Show understanding, tact, and patience when working with diverse team members to maintain positive working relationships throughout the company.

Must be flexible and able to adapt to changes in task priority and able to work under time constraints.Make sound, well-informed judgments with the quality of product at the top of their mind when forming decisions. Lead by example and reinforcing corporate values that lead to the department's success.

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