Job Information
PPD DEVELOPMENT LP Scientist in MIDDLETON, Wisconsin
JOB REQUIREMENTS: Company Name: PPD Development, L.P. Position Title: Scientist Location: 3230 Deming Way, Middleton, WI 53562 Summary of Duties: 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 for stability and analytical testing. Work with multiple functional groups to meet business needs. Plan and organize work with periodic supervision. Set up and maintain analytical instrumentation. Train on routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory procedures and guidelines. Ensure QA findings are addressed appropriately. Provide assistance and training to other team members. Problem solve, either independently or with assistance pertaining to extraction and/or instrumentation problems. Communicate project status to project leader. Perform work assignments accurately, and in a timely and safe manner. Review, interpret, and analyze data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP). Perform self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers. Work with GLP and / or GCP studies and GxP trained. Qualifications: Masters\' degree in Chemistry, Analytical Chemistry, Biology, Biochemistry, Molecular & Cellular Biology, Pharmaceutical Science, Environmental Sciences or related field. In the alternative, the employer will accept a Bachelor\'s in Chemistry, Analytical Chemistry, Biology, Biochemistry, Molecular & Cellular Biology, Pharmaceutical Science, Environmental Sciences or related field and two (2) years\' experience as Analytical Chemist I, Research Assistant, or related lab-based role. Must have any amount of experience with: Experience with: Multiple applicable techniques such as: HPLC, GC, MS, Analytical testing, Bioanalytical testing; Microsoft Excel and Word; Interpreting data by performing trend analysis; Writing detailed justifications about project data to respond to data review findings; Independently optimizing analytical methods; Independently troubleshooting equipment and instruments and mentoring others in troubleshooting; Reviewing clinical and non-clinical protocols and contracts for study design, dosing, and procedures; Performing challenging bioanalytical extraction techniques and providing training for junior analysts on lab techniques and instrumentation; Acting as a mentor for junior analysts; Reviewing documentation of junior analysts and overall study data to ensure regulatory compliance is met. (Recognizing and communicating any potential quality issues.); Analyzing results and providing detailed updates to team and client; Reviewing overall data sets for studies, ensuring data is complete and accurate; and Coordinating lab work and staff to deliver critical client deliverables. Experience can be gained through graduate level course work. To Apply: Send resume to: Thermofisherjobs@thermofisher.com. Reference Number: R-01272582 ***** APPLICATION INSTRUCTIONS: E-Mail a Rsum: Thermofisherjobs@thermofisher.com