Director, Biopharmacuetical Analytical Method Development and Validation Services - GMP

PPD - Middleton, WI (30+ days ago)3.5

Director, Biopharmacuetical Analytical Method Development and Validation Services - GMP - 142382

Expect more from your career. Expect PPD.

The GMP Laboratories business unit of PPD is a market leader in providing GMP analytical services to the Pharmaceutical, Biotechnology, and Medical Device industries. The PPD GMP Laboratories business has 1100 employees located in laboratories in Middleton, Wisconsin and Athlone, Ireland. PPD GMP Laboratories is currently seeking a Director of Biopharmaceutical Services, to be based in our Middleton, Wisconsin facility. This is an exciting opportunity to join a rapidly growing scientific service business within one of the world’s premier drug development companies. The Director will oversee of team of 65 employees, and will be responsible for all financial, operational and technical activities involved in delivering quality biopharmaceutical testing services to our clients.

As the Director, Analytical Method Development and Validation (GMP) you will oversee a team of 65+ employees, and will be responsible for all financial, operational and technical activities involved in delivering quality biopharmaceutical testing services to clients. In this Senior leadership role, you will be based out of our best in class GMP Laboratory in the Madison, WI, area.


Education and Experience:
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12+ years) or equivalent and relevant combination of education, training, & experience
  • 5+ years of management responsibility
  • Preferred qualifications include a graduate degree in protein chemistry, molecular biology, virology, or related discipline, as well as at least 10 years of leadership experience in the cGMP biotechnology industry
  • Business education and/or experience is a plus.
Technical Experience
  • MS or PhD.
  • Clear understanding and experience in development of “greenfield” methods based on product target quality attribute profile quality.
  • Experience in phase appropriate method development and qualification.
  • Global experience in ICH, (FDA, EU and JP) method validation requirements for release and stability indicating methods.
  • Identify and address technical and validation gaps in analytical methods and implement improvements in analytical methods per ICH requirements.
  • Knowledge of data requirements for major amendments for new and existing filing of the clients programs (clinical vis commercial amendments)
  • Protein characterization experience: Knowledge in supporting clients in reference standard qualification by establishing extended characterization techniques.
  • A good level of understanding of protein handling and storage conditions.
  • Strong experience in setting up systems for GMP method development for release and stability testing of Biopharmaceutical starting materials, intermediates, and final products.
Managerial/Leadership Experience
  • Strong leadership skills with Equivalent and relevant combination of education, training, and experience, 5+ years of management responsibility
  • Advanced knowledge of regulatory and business requirements.
  • Expert planning and tracking skills, able to see big picture, well-organized, focused on results, capable of managing multiple projects, excellent time management with respect to priorities and self-management.
  • Strong interpersonal and communication skills for bridging between scientific and business participants, for negotiating timelines and for effective collaboration.
  • Strong verbal communication and expert in written communications.
  • Effective delegation practices to maximize resources utilization
  • Exposure to large group management dynamics.
  • Experience in ensuring effective, proactive and open communications, horizontally and vertically, in order to achieve transparency and clarity of program goals, progress and issues.
  • Experience in managing high performing teams for Client programs
  • Experience in managing and resolving conflicts at functional team level
  • Experience in Management and implementation of effective annual Performance review System.
  • Ability to implement strong career employee development program.
  • Strong ability to work collaboratively within BP team and PPD site functions to ensure that QC analytical methods are aligned with process needs/capabilities and product requirements.

Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.

Organization - Biopharmaceuticals
Primary Location - North America-United States-Wisconsin-Middleton - Research Way