You are viewing a preview of this job. Log in or register to view more details about this job.

Senior Scientist - Biopharmaceuticals

Overview

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory, and lifecycle management services.  Our GMP Laboratories is a workplace where you get to work alongside expert scientists, utilize the newest technologies, and collaborate with industry leaders in drug development. At PPD GMP Laboratories, science is our passion, quality is our commitment, and people are the cornerstone of our success as we strive every day to improve health. We do this by hiring the best, developing ourselves and each other, and recognizing the power of being one team. We offer continued career advancement opportunities, award winning training, and benefits focused on the health and well-being of our employees.

As a Senior Scientist in the Biopharmaceutical Method Development and Validation team you will be responsible for supporting analytical method development and validation activities for a wide variety of cutting-edge biopharmaceutical products.
 

Role Summary:

As a Senior Scientist in the Biopharmaceutical Method Development and Validation team you will be expected to:

  • Possess a thorough understanding of laboratory procedures and be able to reliably conduct complex analyses independently in order to develop and validate methods for biopharmaceutical compounds in a variety of formulations.
  • Design, participate in, and oversee method development activities including critical interpretation of data, summarization of results and findings and communicating them both internally and to clients.
  • Design, participate in, and oversee method validation activities including authoring of study directives and methods, execution of experiments,
  • Drafts, oversees and provides feedback on the compilation and quality review of final study documents.
 

Qualifications

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 5+ 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. 


Essential Knowledge, Skills, Abilities, and Functions:

The successful applicant will:
  • Demonstrate expertise in applicable techniques consisting of one or more of the following: ELISA, CE, HPLC, plate-based assays, Gel Electrophoresis, and Compendial Assays.
  • Independently optimize analytical methods.
  • Collaborate with others within and across departments to meet business needs.
  • Train and maintain proficiency on routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory procedures and guidelines. 
  • Organize and work efficiently with minimal supervision.
  • Perform work assignments accurately, and in a timely and safe manner.
  • Interpret and analyze data for technical soundness, quality, and compliance to protocols, methods, SOPs, client criteria, and Good Manufacturing Practices (GMP).
  • Review their own and other’s data accurately and efficiently and ensure audit findings are addressed appropriately.
  • Apply critical thinking and problem solving, either independently or with assistance, pertaining to method development or analytical challenges.
  • Show proficiency in technical writing and present data clearly and succinctly in both written and verbal form.


Working Environment:

PPD values the health and well-being 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, possess the essential knowledge, skills and ability to excel in this role and want to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application.