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Research Scientist

Company: PPD
Location: Richmond
Posted on: August 7, 2022

Job Description:

PPD clinical research services, Thermo Fisher Scientific's clinical research business is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD clinical research services, we are passionate, deliberate, and driven by our purpose- to improve health!Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD clinical research services, where science is our passion, quality is our commitment and people are the cornerstone of our success.As a Research Scientist, you will conduct and provide technical guidance on scientific method development and validation projects and/or other specialty technologies studies OR perform troubleshooting for your own and others instruments, methods, procedures, and in writie protocols and reports. At PPD clinical research services, we hire the best, develop ourselves and each other, andrecognizethe power of being one team.Weoffer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.Summarized Purpose: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 (GC, ICP-MS, LC/MS, GC/MS etc.) and multiple detection techniques (UV, FL, CAD, ELSD, IC etc.), methods and procedures. Routinely acts as the technical project leader for multiple projects, provide updates, reviews and evaluates data, writes reports and protocols.Essential Functions:

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.

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to BS degree plus 8+ years' of experience or MS plus 6+ years' of experience, or PhD plus 4+ 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:

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

Working Environment:PPD clinical research services values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideaswith diverse groups of peoplein a comprehensible and reasonable manner.
Ableto work upright and stationary and/or standingfor 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 technologywith 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.


Our 4i Values:
Integrity - Innovation - Intensity - Involvement
If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, submit your application - we'd love to hear from you!


Diversity Statement
PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.
PI187850518

Keywords: PPD, Richmond , Research Scientist, Other , Richmond, Virginia

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