Senior Scientist R&D
$94K - $135K/yr
... assist in IVD documentation efforts. You will rise to the challenge of designing, supporting and ... Demonstrated leadership capabilities in assay development in an FDA regulated environment for IVD ...
Senior Scientist R&D
$94K - $135K/yr
... assist in IVD documentation efforts. You will rise to the challenge of designing, supporting and ... Demonstrated leadership capabilities in assay development in an FDA regulated environment for IVD ...
Travel Clinical Laboratory Scientist (CLS)
Atlanta, GA · On-site
$1.3K - $1.5K/wk
Ensure compliance with AABB, CAP, CLIA, FDA, and other regulatory standards, actively preparing for ... Develop and implement laboratory policies, procedures, and quality assurance programs * Assist in ...
Travel Clinical Laboratory Scientist (CLS)
Atlanta, GA · On-site
$1.3K - $1.5K/wk
Ensure compliance with AABB, CAP, CLIA, FDA, and other regulatory standards, actively preparing for ... Develop and implement laboratory policies, procedures, and quality assurance programs * Assist in ...
Scientist II - Reagent & Assay Development
Peachtree Corners, GA · On-site
$43 - $55/hr
... * Assist with verification, validation, and design transfer activities for new and existing ... Knowledge of FDA, ISO, GMP, or quality system requirements. Why Join? * Opportunity to work with ...
New
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Scientist II - Reagent & Assay Development
Peachtree Corners, GA · On-site
$43 - $55/hr
... * Assist with verification, validation, and design transfer activities for new and existing ... Knowledge of FDA, ISO, GMP, or quality system requirements. Why Join? * Opportunity to work with ...
New
Ensure compliance with AABB, CAP, CLIA, FDA, and other regulatory standards, actively preparing for ... Develop and implement laboratory policies, procedures, and quality assurance programs * Assist in ...
Ensure compliance with AABB, CAP, CLIA, FDA, and other regulatory standards, actively preparing for ... Develop and implement laboratory policies, procedures, and quality assurance programs * Assist in ...
Research Assistant
Augusta, GA · On-site
$18 - $25/hr
Location Augusta University Our Health Sciences Campus: 1120 15th Street, Augusta, GA 30912 Our ... GCPs, HAC, FDA, and sponsor-required guidelines. Serves as the patient liaison, schedule ...
Research Assistant
Augusta, GA · On-site
$18 - $25/hr
Location Augusta University Our Health Sciences Campus: 1120 15th Street, Augusta, GA 30912 Our ... GCPs, HAC, FDA, and sponsor-required guidelines. Serves as the patient liaison, schedule ...
... FDA) Office of Regulatory Affairs (ORA). This role will perform operational support for StarLIMS and instruments/applications and scientific workstations. Responsibilities involve the daily ...
... FDA) Office of Regulatory Affairs (ORA). This role will perform operational support for StarLIMS and instruments/applications and scientific workstations. Responsibilities involve the daily ...
... Assist in evaluating complaints for potential quality, safety, or regulatory impact. · Support ... Bachelor's degree in a relevant scientific discipline (e.g., Chemistry, Biology, Microbiology ...
... Assist in evaluating complaints for potential quality, safety, or regulatory impact. · Support ... Bachelor's degree in a relevant scientific discipline (e.g., Chemistry, Biology, Microbiology ...
CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal ... Ensure product compliance with FDA regulations, ISO 13485, and applicable international standards.
Quick apply
CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal ... Ensure product compliance with FDA regulations, ISO 13485, and applicable international standards.
CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal ... Ensure product compliance with FDA regulations, ISO 13485, and applicable international standards.
CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal ... Ensure product compliance with FDA regulations, ISO 13485, and applicable international standards.
Regulatory Affairs Manager (Atlanta)
Atlanta, GA · On-site
$100 - $125/hr
CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal ... Ensure product compliance with FDA regulations, ISO 13485, and applicable international standards.
Regulatory Affairs Manager (Atlanta)
Atlanta, GA · On-site
$100 - $125/hr
CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal ... Ensure product compliance with FDA regulations, ISO 13485, and applicable international standards.
CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal ... Ensure product compliance with FDA regulations, ISO 13485, and applicable international standards.
CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal ... Ensure product compliance with FDA regulations, ISO 13485, and applicable international standards.
Senior QA Manager
Atlanta, GA · On-site
$100 - $125/hr
... cause analysis. * Assist in regulatory inspections and audits, serving as a key team member ... sciences. * At least 3 years in a leadership role. Regulatory Knowledge: * Knowledge of FDA 21 CFR ...
Senior QA Manager
Atlanta, GA · On-site
$100 - $125/hr
... cause analysis. * Assist in regulatory inspections and audits, serving as a key team member ... sciences. * At least 3 years in a leadership role. Regulatory Knowledge: * Knowledge of FDA 21 CFR ...
Manufacturing Engineer
Atlanta, GA · On-site
$70K - $90K/yr
Role Summary Lucid Scientific is seeking a Manufacturing Engineer to assist with the ongoing scale ... Experience operating under a Quality Management System (ISO 9001, ISO 13485, FDA, etc.) *This is an ...
Manufacturing Engineer
Atlanta, GA · On-site
$70K - $90K/yr
Role Summary Lucid Scientific is seeking a Manufacturing Engineer to assist with the ongoing scale ... Experience operating under a Quality Management System (ISO 9001, ISO 13485, FDA, etc.) *This is an ...
Clinical Research Assistant
Atlanta, GA · On-site
$60 - $80/hr
... medical science through high-quality clinical trials. Our Atlanta site is a hub of innovation ... FDA). Required Qualifications * Background: * Certified Nursing Assistant (CNA) with phlebotomy ...
Clinical Research Assistant
Atlanta, GA · On-site
$60 - $80/hr
... medical science through high-quality clinical trials. Our Atlanta site is a hub of innovation ... FDA). Required Qualifications * Background: * Certified Nursing Assistant (CNA) with phlebotomy ...
Support internal audits and prepare documentation for external audits/inspections (e.g., FDA ... Bachelor's degree in a relevant field (Quality, Engineering, Life Sciences) or equivalent ...
Quick apply
Support internal audits and prepare documentation for external audits/inspections (e.g., FDA ... Bachelor's degree in a relevant field (Quality, Engineering, Life Sciences) or equivalent ...
Join our Talent Community for Medical Science Liaisons in Interventional Spine
Atlanta, GA · On-site
... * Assist in development of medical materials, slide decks, and scientific resources * Support ... Working knowledge of FDA regulations, OIG compliance, and industry standards * Excellent scientific ...
Join our Talent Community for Medical Science Liaisons in Interventional Spine
Atlanta, GA · On-site
... * Assist in development of medical materials, slide decks, and scientific resources * Support ... Working knowledge of FDA regulations, OIG compliance, and industry standards * Excellent scientific ...
Metrology Technician
$56K - $70K/yr
Maintain all equipment records and calibration/PM schedule in electronic management system * Assist ... AATB, FDA, ISO and other state/federal regulations * Strong computer skills, including proficiency ...
Metrology Technician
$56K - $70K/yr
Maintain all equipment records and calibration/PM schedule in electronic management system * Assist ... AATB, FDA, ISO and other state/federal regulations * Strong computer skills, including proficiency ...
Manufacturing Quality Engineer
Suwanee, GA · On-site
$69K - $89K/yr
Process Validation and Manufacturing Controls * Assist in developing and executing validation ... Participate in FDA, Notified Body and customer audits. * Lead investigation and corrective actions ...
Manufacturing Quality Engineer
Suwanee, GA · On-site
$69K - $89K/yr
Process Validation and Manufacturing Controls * Assist in developing and executing validation ... Participate in FDA, Notified Body and customer audits. * Lead investigation and corrective actions ...
Manufacturing Quality Engineer
Suwanee, GA · On-site
$69K - $89K/yr
Process Validation and Manufacturing Controls * Assist in developing and executing validation ... Participate in FDA, Notified Body and customer audits. * Lead investigation and corrective actions ...
Manufacturing Quality Engineer
Suwanee, GA · On-site
$69K - $89K/yr
Process Validation and Manufacturing Controls * Assist in developing and executing validation ... Participate in FDA, Notified Body and customer audits. * Lead investigation and corrective actions ...
Clinical Research Manager
Atlanta, GA · On-site
$100 - $125/hr
Supervise and provide leadership to Clinical Research Coordinators and Research Assistants ... Bachelor's degree in nursing, life sciences, public health, healthcare administration, or a related ...
Clinical Research Manager
Atlanta, GA · On-site
$100 - $125/hr
Supervise and provide leadership to Clinical Research Coordinators and Research Assistants ... Bachelor's degree in nursing, life sciences, public health, healthcare administration, or a related ...
Assistant Fda Scientist information
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Job description
Passionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
Senior Scientist, Molecular Assay Development in R&DPassionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
We are looking for a Senior Scientist within the Molecular Assay Development group to co-lead the design and development of assays in support of IVD & CDx programs. In this role you will lead projects with staff scientists that lead the wet lab efforts during development and guide documentation specialists to assist in IVD documentation efforts. You will rise to the challenge of designing, supporting and documenting V&V studies for molecular assays, ensure project deliverables are compliant with applicable regulations, and provide technical reports to support FDA submissions. You are expected to collaborate cross-functionally with members of technology development, bioinformatics, quality control, regulatory affairs, and the clinical lab.
What you'll do:
Maintain overall knowledge of the assay characteristics
Provide scientific leadership to cross-functional teams
Manage and lead generation of R&D design documents
Lead validation team from project inception through launch including sample selection, hands-on laboratory validation, establishing workflow and SOPs, and authoring validation plans and summaries
Ensure activities are consistent with project critical path and respond appropriately to changing priorities
Assist in developing and tracking project budgets
Design assay performance specifications
Ensure assay development process meets milestones and timelines
Troubleshoot and solve technical issues
Maintain compliant laboratory documents and procedures
Proactively improve efficiency, quality and effectiveness of R&D efforts
Qualifications:
PhD in Nucleic Acids Biochemistry, Molecular Biology, or related field with 3+ years industry experience -or- MS with industry experience commensurate with requirements
Demonstrated leadership capabilities in assay development in an FDA regulated environment for IVD products under design controls
Strong technical expertise and hands on experience with nucleic acid technologies with a preference towards NGS, PCR, and qPCR techniques
Proven ability to apply principles of quality control and quality assurance to development activities
Strong understanding of FDA, EUA, and other global regulatory requirements
Demonstrated technical and project leadership expertise
Good organization skills, detailed oriented mindset
Ability to thrive in a fast paced environment
Team driven
$94,000.00-$135,000.00
The expected salary range above is applicable if the role is performed from Illinois and may vary for other locations (California, Colorado, New York). Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.
We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.