Director, Method Development and Validation / Protein Characterization

PPD   •  

Middleton, WI

Industry: Pharmaceuticals & Biotech

  •  

11 - 15 years

Posted 72 days ago

This job is no longer available.

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 employees located in laboratories in Middleton, Wisconsin and Athlone, Ireland. PPD GMP Laboratories is currently seeking a Director of Analytical Method Development and validation (AMDV), 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 75 employees, and will be responsible for all financial, operational and technical activities involved in delivering quality biopharmaceutical testing services to our clients.

We seek a highly collaborative, motivated and innovative candidate with demonstrated expertise to provide scientific and technological leadership in biophysical/analytical characterization to enable and support biologics drug development for large molecules. Key responsibilities include, management of a team focused on characterization of monoclonal and multi-specifics antibodies, antibody drug conjugates (ADC) and other protein therapeutics using state-of-art technology. Provide creative approaches to support client’s comparability protocols to drive the process characterization and/or process qualification studies.

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Qualifications

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

  • PhD, 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

  • 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 and Management Experience

  • 5+ years of management responsibility

  • Experience in phase appropriate method development and qualification.

  • Experience in protein Characterization or execution of complex comparability protocols.

  • 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 client’s programs (clinical vis commercial amendments)

  • Protein characterization experience: Knowledge in supporting clients in reference standard qualification by establishing extended characterization techniques.

  • 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
  • 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.

Responsibilities

  • Operationalize an efficient state-of-art protein characterization for drug substance or drug products e.g. monoclonal- and bispecific antibodies, ADCs and proteins
  • Apply protein structural and biophysical principles to optimize protein characterization methods for determination of post-translation modifications (PTM).
  • Identify and implement new technologies/applications/external collaborations in support of client needs; interface with new technology providers to understand the technology advancement within the analytical space.
  • Manage the workflow of characterization unit to ensure quality, priorities and timelines.
  • Recruit, retain, and develop high quality staff; manage performance of direct and indirect reports
  • Execution of master validation plan as required by clients.

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