|Date Posted||June 3, 2021|
|Address||8551 Research Way, Suite 90|
PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, 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® Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success.
As a Research Scientist you will oversee complex analytical development and/or specialty technology projects to create new analytical methods, enhance existing methods, and transfer client-provided methods using multiple instrumentation techniques (HPLC, GC, UPLC, ICP-MS, LC/MS, GC/MS etc.) and multiple detection techniques (UV, FL, CAD, ELSD, IC etc.).
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.
Oversees complex analytical development and/or specialty technologies projects to create new analytical methods, enhance existing methods, and transfer client-provided methods using multiple instrumentation techniques (HPLC, GC, UPLC, ICP-MS, LC/MS, GC/MS etc.) and multiple detection techniques (UV, FL, CAD, ELSD, IC etc.). Provides technical and regulatory consulting to internal groups and clients about their programs. Provides technical guidance and mentorship to senior staff members in performing laboratory activities. Routinely acts as the technical project leader for multiple projects, interacts with clients to provide technical project updates, reviews and evaluates data, writes reports and protocols.
- Independently plans the best scientific approach to develop analytical methods and/or other specialty technologies studies that meet client requirements.
- Acts as on-site Subject Matter Expert (SME) for instrumentation / technique / technology.
- Evaluates available technical options to obtain desired quality of analytical results, economics, ease of introduction into a production environment, and robustness in analytical applications.
- Demonstrates viability of in-house developed methods and methods transferred from clients by designing appropriate validation experiments or other appropriate aspects of specialty methodology or technology.
- Ability to lead client discussions regarding project definitions, technical information exchanges and discussions of project status. Provides recommendations to clients on technical and regulatory issues.
- Reviews protocols, project status reports, final study reports and other project-related technical documents.
- Assists business development group in technical sales and marketing, and in preparation of technical marketing materials, and presents posters and makes podium presentations at 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 8+ years).
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:
- Effective written and oral communication skills as well as presentation skills
- Knowledge and application of industry best practices not yet represented by global regulatory requirements
- Full theoretical and hands-on understanding and knowledge of general chemistry and separation science
- Demonstrated ability of integrating changing regulatory or industry standards and comprehension of technical limitations
- Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance
- Ability to independently review and understand project proposals/plans
- Proven ability in technical writing skills
- Ability to work in a collaborative work environment with a team
- Proven problem solving and troubleshooting abilities
- Ability to independently optimize analytical methods
- Time management and project management skills
PPD 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 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.