|Date Posted||January 21, 2021|
|Address||8551 Research Way, Suite 90|
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/284382895/ce7832f6d9
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.
Our Gene Cell Therapy team is one of the fastest growing teams at our Middleton location, as one of the newer branches of our services. This team focuses on large molecule analytical testing centered around genetic disease remedies. Surrounded by varying levels of Scientists, you will have the support to succeed, as well as the opportunity to assist the progress of others. Check out our website for more information about our lab services and further information about PPD: https://www.ppd.com/our-solutions/ppd-laboratories/gmp-lab/
As a Scientist you will perform 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. 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.
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 for stability and analytical testing.
Works with multiple functional groups to meet business needs.
Plans and organizes work with periodic supervision.
Sets up and maintains analytical instrumentation.
Trains on routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory procedures and guidelines.
Ensures QA findings are addressed appropriately.
Aids and training to other team members.
Problem solving, either independently or with assistance pertaining to extraction and/or instrumentation problems.
Communicates project status to project leader.
Performs work assignments accurately, and in a timely and safe manner.
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. Molecular Biology/genetics degree or experience preferred. Work with large molecules preferred.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ 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:
- Demonstrated knowledge of multiple applicable techniques such as: qPCR, ddPCR, ELISA, Western Blot, Sanger Sequencing, SDS-PAGE. Experience with HPLC, GC, MS, Dissolution Testing,Inhalation Testing, Biopharmaceutical Testing, Karl Fischer, UV-Vis, FT-IR, TOC, also helpful.
- Proficient in Microsoft Excel and Word
- Proven ability to interpret data by performing trend analysis
- Proven ability in technical writing skills
- Ability to independently optimize analytical methods
- Proven problem solving and troubleshooting abilities
- Good written and oral communication skills
- Time management and project management skills
- Ability to work in a collaborative work environment with a team
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
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.