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Director Analytical Development

Reference Number: 3112
Location: PA

Our client is a major global pharmaceutical and biotech company committed to improving health worldwide.  They have asked us to assist them in their search for a Director Analytical Development.

Major tasks and responsibilities will include:

  • Provides strategic and scientific guidance in all CMC technical areas, in particular, serves as in-house large molecule analytical development expert, including structure-function relationships, test method development and validation and establishment of specifications.
  • Guides teams in the preparation of technical reports and regulatory submissions, participates in their review and approval, and contributes to the development of strategies to comply with US and international regulatory standards.
  • Provides scientific guidance on complex manufacturing investigations.
  • Leads discussions to identify new scientific/technical opportunities for the large molecule product platform, and negotiates/influences acceptance of new opportunities and concepts through scientific leadership.
  • Supports a learning environment and fosters a culture of scientific excellence through training, influence and leading by example.
  • Ability to foster team productivity and cohesiveness and to work collaboratively in a complex, matrix environment.

We seek candidates with the following qualifications:

  • Ph.D. in Biochemistry, Analytical Chemistry, Chemical Engineering or related discipline is required.
  • At least 12 years of relevant experience in biopharmaceutical development, licensure and post-marketing support is required.
  • Primary in-depth experience and knowledge in large molecule analytics, as well substantial experience in other CMC functional areas (ie: Cell Culture, API Purification, Drug Product) is required.
  • Demonstrated ability to develop and transfer biologics manufacturing processes and product testing that meets customer needs is required.
  • Broad knowledge of the biopharmaceutical industry, including in-depth operating knowledge of the processes and functions involved in biologics drug development and life cycle management is required.
  • Experience with regulatory writing and submissions (ie: INDs, BLAs, etc.) is required.
  • A proven track record in leading scientific teams, including direct and/or indirect people management experience is required.
  • A proven ability to execute and get results in a matrix environment through leadership and accountability.
  • Excellent interpersonal skills with the ability to adapt effectively to rapidly changing organizational issues, structures and dynamics.
  • Demonstrated ability to make difficult decisions in a timely fashion.
  • Strong analytical problem solving skills and organizational skills.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 3112. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.