Associate Research Scientist - Molecular Genomics - Microarray

Thermo Fisher Scientific•Richmond, VA

1d•Onsite

About The Position

This is a fully onsite role based at our laboratory at 2244 Dabney Road, Richmond, VA. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations. Discover Impactful Work: Independently performs a variety of complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices. Responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol, and product specifications. Coordinates laboratory activities of other team members in conjunction with the lab management. Performs study design and protocol authoring. Leads data evaluation and study close-out. Provides technical guidance and mentorship to junior scientists. Trains on routine operation, maintenance, and theory of complex analytical instrumentation, SOPs, and regulatory procedures and guidelines. A Day in the Life: Operate and maintain the SwiftArrayStudio instrument for routine hybridization and scanning. Perform RNA isolation, labeling, and QC using standard molecular biology tools. Develop SOPs, conduct IQ/OQ/PQ, and ensure assay reproducibility. Collaborate with vendors for training, troubleshooting, and performance qualification. Review and verify data quality before delivery to clients or data systems. Coordinate with automation and informatics teams for process efficiency. Trains on routine operation, maintenance, and theory of complex analytical instrumentation, SOPs, and regulatory procedures and guidelines. Independently performs and gives guidance on a variety of complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices for stability and analytical testing. Completes all laboratory documentation in clear and accurate language and according to SOP and GLPs. Leads troubleshooting for various equipment & instruments Reviews and compiles results from assignments and makes initial determination on acceptability per SOP acceptance criteria. Reviews overall study results. Navigates the OOS/OOT/Atypical investigation process. Leads more complex investigations and Root Cause Analysis and leads CAPAs. Independently manages QC responsibilities. Communicates project status to project leader and helps to address gaps and solutions to overcoming roadblocks in project team workflow. May act as project leader. Coordinates laboratory activities of other team members in conjunction with lab management. Performs study design & protocol authoring. Leads data evaluation and study close-out. Independently completes QA facing tasks. Authors and leads more complex quality records (eg. quality records which may require more in-depth investigation to identify true root causes, quality records requiring cross departmental input and/or collation of data etc.) Mentors other staff members in applicable areas as needed. Keys to Success: BS and six years of experience OR MS and four years of experience OR PhD and two years of experience In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role Knowledge, Skills and Abilities: Knowledge of relevant scientific principles applicable to role Ability to independently perform root cause analysis for quality records Proficiency on technical operating systems Proven problem solving and troubleshooting abilities Proven ability in technical writing skills Time management and project management skills Good written and oral communication skills Ability to work in a collaborative work environment with a team Ability to train junior staff Ability to mentor others on technical operating systems Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and regulatory guidance Working Conditions and Environment: Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment. Occasional drives to site locations, occasional domestic travel. Exposure to biological fluids with potential exposure to infectious organisms. Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste. Personal protective equipment required such as protective eyewear, garments and gloves. Exposure to fluctuating and/or extreme temperatures on rare occasions. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

Requirements

BS and six years of experience OR MS and four years of experience OR PhD and two years of experience
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role
Knowledge of relevant scientific principles applicable to role
Ability to independently perform root cause analysis for quality records
Proficiency on technical operating systems
Proven problem solving and troubleshooting abilities
Proven ability in technical writing skills
Time management and project management skills
Good written and oral communication skills
Ability to work in a collaborative work environment with a team
Ability to train junior staff
Ability to mentor others on technical operating systems
Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and regulatory guidance

Responsibilities

Independently performs a variety of complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices.
Responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol, and product specifications.
Coordinates laboratory activities of other team members in conjunction with the lab management.
Performs study design and protocol authoring.
Leads data evaluation and study close-out.
Provides technical guidance and mentorship to junior scientists.
Trains on routine operation, maintenance, and theory of complex analytical instrumentation, SOPs, and regulatory procedures and guidelines.
Operate and maintain the SwiftArrayStudio instrument for routine hybridization and scanning.
Perform RNA isolation, labeling, and QC using standard molecular biology tools.
Develop SOPs, conduct IQ/OQ/PQ, and ensure assay reproducibility.
Collaborate with vendors for training, troubleshooting, and performance qualification.
Review and verify data quality before delivery to clients or data systems.
Coordinate with automation and informatics teams for process efficiency.
Independently performs and gives guidance on a variety of complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices for stability and analytical testing.
Completes all laboratory documentation in clear and accurate language and according to SOP and GLPs.
Leads troubleshooting for various equipment & instruments
Reviews and compiles results from assignments and makes initial determination on acceptability per SOP acceptance criteria.
Reviews overall study results.
Navigates the OOS/OOT/Atypical investigation process.
Leads more complex investigations and Root Cause Analysis and leads CAPAs.
Independently manages QC responsibilities.
Communicates project status to project leader and helps to address gaps and solutions to overcoming roadblocks in project team workflow.
May act as project leader.
Independently completes QA facing tasks.
Authors and leads more complex quality records (eg. quality records which may require more in-depth investigation to identify true root causes, quality records requiring cross departmental input and/or collation of data etc.)
Mentors other staff members in applicable areas as needed.