RESEARCH SCIENTIST - PCR TESTING

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 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 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.

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 (HPLC, GC, UPLC, 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 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:

• 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 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.

PPD Defining Principles:
- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you

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.