Research Scientist

Thermo Fisher Scientific•Richmond, VA

1d•Onsite

About The Position

Position: Research Scientist Location: Richmond, VA - 8700 Quioccasin Road Department: Chromatography Science - Research and Development Department This is a fully onsite role based at our BIOA Laboratory in 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: The Research Scientist conducts and provides technical guidance on scientific method development and validation projects and/or other specialty technologies studies OR performs troubleshooting for own and others instruments, methods, procedures, and in writing protocols and reports. Designs and executes method development/validation and/or extractable/leachable studies independently and interprets and reviews analytical data for self and others OR designs and executes multiple stability and inhalation procedures as well as assists others in performing routine maintenance and troubleshooting on multiple instruments (HPLC, GC, UPLC, ICP-MS, LC/MS, GC/MS etc.) methods and procedures. Routinely acts as the technical project leader for multiple projects, provide updates, reviews and evaluates data, writes reports and protocols. A Day in the Life: Independently performs analytical method development/optimization/validation, and/or other specialty technologies studies OR method transfers for pharmaceutical and biopharmaceutical compounds or equivalent levels of expertise and experience in mass spectrometetry or other related areas such as structural elucidation or extractable leachable testing in a variety of formulations and/or delivery systems. Designs and executes experiments independently for self and others. Writes, reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents. Leads analytical (procedural and instrumental) troubleshooting sessions. Assists business development group in technical sales and marketing, and presents posters at technical conferences. Leads in preparation and implementation of SOPs and quality systems, as well as developing innovative technology and in evaluating and implementing new capabilities. Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP). Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.

Requirements

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 8+ years) or equivalent combination of education, training, & experience.
Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 6+ years)
PhD and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 4+ years)
Intermediate knowledge of general chemistry and separation science
Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance
Full knowledge of technical operating systems
Ability to independently optimize analytical methods
Ability to independently perform root cause analysis for method investigations
Proven technical writing skills
Proven problem solving and troubleshooting abilities
Effective written and oral communication skills as well as presentation skills
Time management and project management skills
Ability to mentor others on technical operating systems
Ability to independently review and understand project proposals/plans
Ability to work in a collaborative work environment with a team
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary and/or standing for typical working hours.
Able to lift and move objects up to 25 pounds.
Able to work in non-traditional work environments.
Able to use and learn standard office equipment and technology with proficiency.
May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Responsibilities

Conducts and provides technical guidance on scientific method development and validation projects and/or other specialty technologies studies
Performs troubleshooting for own and others instruments, methods, procedures, and in writing protocols and reports.
Designs and executes method development/validation and/or extractable/leachable studies independently and interprets and reviews analytical data for self and others
Designs and executes multiple stability and inhalation procedures as well as assists others in performing routine maintenance and troubleshooting on multiple instruments (HPLC, GC, UPLC, ICP-MS, LC/MS, GC/MS etc.) methods and procedures.
Routinely acts as the technical project leader for multiple projects, provide updates, reviews and evaluates data, writes reports and protocols.
Independently performs analytical method development/optimization/validation, and/or other specialty technologies studies OR method transfers for pharmaceutical and biopharmaceutical compounds or equivalent levels of expertise and experience in mass spectrometetry or other related areas such as structural elucidation or extractable leachable testing in a variety of formulations and/or delivery systems.
Designs and executes experiments independently for self and others.
Writes, reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents.
Leads analytical (procedural and instrumental) troubleshooting sessions.
Assists business development group in technical sales and marketing, and presents posters at technical conferences.
Leads in preparation and implementation of SOPs and quality systems, as well as developing innovative technology and in evaluating and implementing new capabilities.
Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP).
Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.