Associate Staff Scientist - Product Lifecycle Specialist
Description The IVD Device Validation Department supports the analytical studies for regulatory submissions of molecular in vitro diagnostic (IVD) products developed by bioM rieux.
The Associate Staff Scientist (Product Lifecycle Specialist) is a salaried position with laboratory leadership and product lifecycle support responsibilities.
The Associate Staff Scientist works to meet deadlines in a dynamic environment and has the temperament to operate proactively and collaboratively in a team in support of pre-market and post-market product performance validation and sustainment activities.
Laboratory tasks will focus on molecular and microbiological experiments and procedures with associated collection, analysis, verification and recording of data in accordance with established protocols and work instruction documents, regulations, safety requirements, and the quality system.
The Product Lifecycle Specialist will also liaise and coordinate with Regulatory Affairs, Post-Market Surveillance, and Research and Development teams to collect and/or review data and literature to respond to Health Authority questions or requests and to maintain and revise documentation and performance claims through the product lifecycle.
Work is primarily collaborative and requires the ability to effectively and respectfully communicate and coordinate with peers and management.
The position requires expert laboratory technical and organizational skills, a strong foundation in sequence analysis and PCR technology, excellent technical writing and communication skills, attention to detail, critical thinking and good judgement, troubleshooting and problem-solving, data analysis, and a dedication to the mission and goals of the department and bioM rieux.
An Associate Staff Scientist is expected to self-direct in work and assignments with minimal supervision and may also supervise research associates and intern/trainees.
Please include a cover letter indicating your interest in and fit with the position.
Essential Job Duties and Responsibilities Perform all work in compliance with company quality procedures and standards.
Follow policies and procedures and conduct oneself professionally and in accordance with the bioM rieux Employment Handbook.
Ensure data integrity and accurate record-keeping by collecting, recording (laboratory notebooks and study worksheets), analyzing, and verifying data in compliance with SOPs, WIDs, and Study Protocols.
Oversee use and maintenance of laboratory equipment, supplies/inventory, and/or lab spaces according to operational, quality control, and safety requirements, protocols, SOPs, and WIDs.
Demonstrate expertise in routine or complex calculations and laboratory techniques as well as graphing data and statistical analyses.
Maintains and instructs others in the use of laboratory tools and databases (e.
g.
for tracking of reagents, organism strains, samples, specimens, etc.
) Act as an exemplary lab citizen and team-member.
Proactively teach, coordinate, collaborate, and communicate with supervisors and peers within and across teams and functional groups for lab activities, cleaning, equipment use, specific assigned tasks and projects, and sharing of knowledge, skills, and ideas.
Lead investigations and complex experiments, as well as protocol and process development, optimization, revision, and execution.
Play an active role in anticipating, identifying, and mitigating risks or hazards in processes, experiments and projects.
Use data and critical thinking to evaluate successful performance and/or deficiencies in products and experiments.
Includes identification of patterns and trends, and critical review of results.
Propose strategies and solutions for technical and operational issues and when deficiencies are identified.
Develops and maintains a technical, system level understanding of products.
Train others on laboratory and departmental practices and procedures.
Demonstrate good coordination and communication with direct reports.
Exercise good judgment and prioritization in time and task management, experimental design and execution, and presentation of results and outcomes to peers and leadership.
Be accountable for task completion and follow-through to maintain project goals and timelines.
Balance competing tasks from multiple projects.
Highly competent in written and oral communication of results, and development of study protocols and reports.
Stays current with knowledge of regulatory requirements, guidelines, and expectations for establishing performance of diagnostic products and maintains broad knowledge of state-of-the-art principles and theories.
Attend and participate in all assigned meetings at the group, department and company level (includes lifecycle documentation and sequence surveillance team meetings).
Attend and participate in learning and training opportunities.
May participate in scientific conferences, as appropriate.
May manage research associates and/or interns.
Performs other duties as assigned.
Qualifications:
Education and Experience Master's degree in biology, microbiology or equivalent and at least six years of relevant experience.
May also consider exceptional candidates with a Bachelor's degree and at least eight years of relevant experience, preferably in a clinical or industrial setting.
Molecular biology and/or microbiology laboratory experience required, with competency in PCR technology and sequence analysis.
Supervision and management experience in a professional setting preferred.
Technical writing experience preferred.
Knowledge, Skills, and Abilities Strong interpersonal skills and the ability to work with a variety of people (Research associates, Directors, Scientists, Regulatory professionals, Engineers, Project coordinator/managers) from different education and cultural backgrounds.
Excellent oral and written communication skills.
Able to independently plan experiments, analyze data and troubleshoot problems in real-time.
Strong organization and project management skills.
Ability to work in a biosafety laboratory environment and comply with safety and equipment use requirements.
Recommended Skills Attention To Detail Biology Biosafety Calculations Claim Processing Clinical Works Estimated Salary: $20 to $28 per hour based on qualifications.
The Associate Staff Scientist (Product Lifecycle Specialist) is a salaried position with laboratory leadership and product lifecycle support responsibilities.
The Associate Staff Scientist works to meet deadlines in a dynamic environment and has the temperament to operate proactively and collaboratively in a team in support of pre-market and post-market product performance validation and sustainment activities.
Laboratory tasks will focus on molecular and microbiological experiments and procedures with associated collection, analysis, verification and recording of data in accordance with established protocols and work instruction documents, regulations, safety requirements, and the quality system.
The Product Lifecycle Specialist will also liaise and coordinate with Regulatory Affairs, Post-Market Surveillance, and Research and Development teams to collect and/or review data and literature to respond to Health Authority questions or requests and to maintain and revise documentation and performance claims through the product lifecycle.
Work is primarily collaborative and requires the ability to effectively and respectfully communicate and coordinate with peers and management.
The position requires expert laboratory technical and organizational skills, a strong foundation in sequence analysis and PCR technology, excellent technical writing and communication skills, attention to detail, critical thinking and good judgement, troubleshooting and problem-solving, data analysis, and a dedication to the mission and goals of the department and bioM rieux.
An Associate Staff Scientist is expected to self-direct in work and assignments with minimal supervision and may also supervise research associates and intern/trainees.
Please include a cover letter indicating your interest in and fit with the position.
Essential Job Duties and Responsibilities Perform all work in compliance with company quality procedures and standards.
Follow policies and procedures and conduct oneself professionally and in accordance with the bioM rieux Employment Handbook.
Ensure data integrity and accurate record-keeping by collecting, recording (laboratory notebooks and study worksheets), analyzing, and verifying data in compliance with SOPs, WIDs, and Study Protocols.
Oversee use and maintenance of laboratory equipment, supplies/inventory, and/or lab spaces according to operational, quality control, and safety requirements, protocols, SOPs, and WIDs.
Demonstrate expertise in routine or complex calculations and laboratory techniques as well as graphing data and statistical analyses.
Maintains and instructs others in the use of laboratory tools and databases (e.
g.
for tracking of reagents, organism strains, samples, specimens, etc.
) Act as an exemplary lab citizen and team-member.
Proactively teach, coordinate, collaborate, and communicate with supervisors and peers within and across teams and functional groups for lab activities, cleaning, equipment use, specific assigned tasks and projects, and sharing of knowledge, skills, and ideas.
Lead investigations and complex experiments, as well as protocol and process development, optimization, revision, and execution.
Play an active role in anticipating, identifying, and mitigating risks or hazards in processes, experiments and projects.
Use data and critical thinking to evaluate successful performance and/or deficiencies in products and experiments.
Includes identification of patterns and trends, and critical review of results.
Propose strategies and solutions for technical and operational issues and when deficiencies are identified.
Develops and maintains a technical, system level understanding of products.
Train others on laboratory and departmental practices and procedures.
Demonstrate good coordination and communication with direct reports.
Exercise good judgment and prioritization in time and task management, experimental design and execution, and presentation of results and outcomes to peers and leadership.
Be accountable for task completion and follow-through to maintain project goals and timelines.
Balance competing tasks from multiple projects.
Highly competent in written and oral communication of results, and development of study protocols and reports.
Stays current with knowledge of regulatory requirements, guidelines, and expectations for establishing performance of diagnostic products and maintains broad knowledge of state-of-the-art principles and theories.
Attend and participate in all assigned meetings at the group, department and company level (includes lifecycle documentation and sequence surveillance team meetings).
Attend and participate in learning and training opportunities.
May participate in scientific conferences, as appropriate.
May manage research associates and/or interns.
Performs other duties as assigned.
Qualifications:
Education and Experience Master's degree in biology, microbiology or equivalent and at least six years of relevant experience.
May also consider exceptional candidates with a Bachelor's degree and at least eight years of relevant experience, preferably in a clinical or industrial setting.
Molecular biology and/or microbiology laboratory experience required, with competency in PCR technology and sequence analysis.
Supervision and management experience in a professional setting preferred.
Technical writing experience preferred.
Knowledge, Skills, and Abilities Strong interpersonal skills and the ability to work with a variety of people (Research associates, Directors, Scientists, Regulatory professionals, Engineers, Project coordinator/managers) from different education and cultural backgrounds.
Excellent oral and written communication skills.
Able to independently plan experiments, analyze data and troubleshoot problems in real-time.
Strong organization and project management skills.
Ability to work in a biosafety laboratory environment and comply with safety and equipment use requirements.
Recommended Skills Attention To Detail Biology Biosafety Calculations Claim Processing Clinical Works Estimated Salary: $20 to $28 per hour based on qualifications.
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