Senior Scientist - Cell Bioassay
Company Overview
PPD is a leading global Contract Research Organization - currently operating in nearly 50 countries! At PPD we are passionate, deliberate, and driven by our purpose - to improve health. Our organization works with a diverse group of pharmaceutical companies to help bend the cost and time curve of small molecule, biologic, and vaccine product development.
This position is located at our GMP lab in Middleton, WI - the largest GMP laboratory in North America. Check out this video for a brief introduction to our lab as told by our scientists: https://vimeo.com/533240741.
We hire the best, develop ourselves and each other, and recognize the power of being one team. You will receive extensive training to allow you to be successful at PPD, and it's not just talk - our award-winning training programs speak for themselves. In addition, our teams support career growth, allowing you to explore the numerous career pathways available once you become part of our PPD team.
Role Description
As a Senior Scientist, you are committed to excellence and high-quality results in your complex laboratory analysis of key pharmaceutical products. Beyond the bench, you work as a project leader with a strong sense of urgency aligned to our customers, and you are committed to delivering results.
Summarized Purpose
Possesses a thorough understanding of laboratory procedures and can reliably conduct complex analysis with increased independence. Performs a variety of complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices. Follows validated or experimental analytical procedures with periodic direct supervision. Responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol and product specifications. Enters data into databases and reports. Performs self-review for own data prior to QC submission.
Essential Functions
- Independently performs method validations, method transfers and analytical testing of pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or delivery systems. Understands and conforms to methods and protocols applicable to assigned tasks. Designs and executes experiments with minimal supervision
- Prepares study protocols, project status reports, final study reports and other project-related technical documents
- Communicates data and technical issues to the client and responds to client needs and questions
- Mentors, trains and coordinates laboratory activities of other team members and assists in troubleshooting instrument and analytical problems
- Assists with quality systems and new equipment
- Assists in designing method validation or method transfer protocols and establish project timelines
- Reviews, interprets, and analyzes data for technical, quality, and compliance to protocols, methods, SOPs, client criteria, and GMP or 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
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)
- PhD will be equivalent to aforementioned Bachelor’s degree + 5 years required experience.
Knowledge, Skills and Abilities
- Proficient in use of analytical instrumentation such as BioPharmaceutical Testing (ELISA, Gel Electrophoresis, PCR, qPCR).
- Solid understanding and knowledge of general chemistry and separation science
- Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance
- Ability to utilize Microsoft Excel and Work to perform tasks
- Maintain a laboratory notebook and complete all documentation with clear and accurate language and according to the SOP
- Proficiency on technical operating systems
- Proven problem solving and troubleshooting abilities
- Effective oral and written communication skills
- Proven ability in technical writing skills
- Time management and project management skills
- Ability to work in a collaborative work environment with a team
- Proven problem solving and troubleshooting abilities
- Ability to train junior staff
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, 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.
What To Expect Next
We look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.