About the Job
This position will have a key leadership role with in the Process Development Analytics (PDA) group in the Biologics Process Development in New Jersey. The role will report to the Associate Director of PDA and will be based in Hopewell location near Princeton, NJ. Specifically, the role will involve planning, managing and execution of PDA activities, leading a small group, to ensure timely analytics in support of multiple biological programs.
- The ideal candidate will manage a small group and supervise multiple in-process testing and development activities within PDA.
- Develop analytical methods for new biologics as needed and trouble shoot technical problems.
- Write and review reports, and ensure accuracy of data PDA communicates to its customers.
- Represent PDA on matrix and cross functional teams.
- Involved in the training of team member and assuring alignment across the network of platform processes.
- Ensure continuous improvement by developing and evaluating new analytical techniques.
- Remain current on industry trends with in PDA
- Perform bench support wet laboratory work will be required.
- Opportunity to support technical agenda and analytical gap analysis of early phase Biologics.
Responsibilities of PDA Group
- Ensures high quality in process protein analytical information is available to New Jersey Biologics Process Development so timely decisions can be made.
- Collaborate with Process Development, Analytical Development, and Research and Development to ensure transfer of methods and information occurs seamlessly to partners.
- Maintain alignment with the Analytic network on platform methods.
PhD in Analytical Biochemistry, Analytical Chemistry or Protein Chemistry with 7-9 years industrial experience or MS in Analytical Chemistry with 10 to 12 years of analytical and group management experience.
- Excellent verbal and written communication skills and is a team player.
- In-depth and broad experience in Bioanalytical techniques as they apply to Biologics Product Quality and related process impurities
- Experience in electrophoresis (Capillary and traditional gel technique)
- Experience with chromatography techniques (HPLC, UPLC, IEX, preparative LC) with multiplemodes of detection including UV, FL, MS, MALLS and RI.
- Experience in immunoassays (ELISA, 1D and 2D western blots)
- Automation experience in either analytical or process setting is highly desirable
- Biophysical techniques – FTIR, Raman, DSC, DLS and MALLS are desirable
- Working knowledge of Design of Experiments and Factorial Design
- Experience of managing a group of scientists is desirable
- Appreciation of the scientific basis and experimental background of upstream and downstream process development activities is highly desirable
- Knowledge of GLP/GMP laboratory and compliance documentation is a plus