Quality Recruiting. Established Experts.

Senior Director/Head, Analytical Sciences

Reference Number: 3902
Location: MD

Our client is a biopharmaceutical company with one of the most robust pipelines in industry. They have asked us to assist them in their search for a Senior Director/Head, Analytical Sciences. 

Major tasks and responsibilities will include:

  • Provides scientific, operational, and strategic leadership for the Analytical Sciences group responsible for structural characterization of a broad range of biologic molecules
  • Leads the group responsible for the development, qualification and transfer of in-process characterization and release test methods for the company’s biologics portfolio.
  • Establishes the tactics, direction, and objectives for a diverse group of analytical functions.
  • Develops strategic plans for clinical and commercial products in support of clinical product development, product life-cycle management and associated regulatory submissions. 
  • Provides technical advice, as needed, to assure the highest quality of data is developed and presented. 
  • Oversees the creation and review of presentations for external scientific meetings and conferences to assure they meet corporate standards.
  • Serves as Development representative in communications, both verbal and written, with regulatory agencies, R&D product development teams for all therapeutic areas, and other internal and external groups of interest.
  • Proactively engages in diligence activities with the Business Development group and authors the summary of findings.
  • Oversees the creation and review of documents such as: method development reports, SOPs, validation protocols/reports, CMC regulatory filings (IND, IMPD, BLA, etc.), and scientific journal publications.
  • Develops cutting-edge technologies in order to improve efficiency of in-process testing and product characterization.
  • Actively maintains and evolves the department’s strategic direction to meet organizational needs.
  • Maintains effective communications with other functional areas.
  • Facilitates tech transfer.
  • Assures all laboratory documentation and other regulatory compliance systems are maintained according to corporate standards.
  • Ensures effective day to day operations of the organization including talent development, performance management, budgeting, etc. 
  • Inspires and supports a can-do, solutions focused, science led culture within the organization.
  • Develops leaders at all levels within the organization to become effective functional, scientific and matrix leaders.
  • Leads CMC team(s) across Biopharmaceutical Development, as needed.

 We seek candidates with the following qualifications:

  • PhD in Biochemistry, Chemistry, or equivalent required.
  • Must have significant and established experience in the pharmaceutical industry.
  • Required relevant experience in analytical method development, optimization, validation, cGMP testing, and tech transfer for a portfolio of diverse molecular formats. 
  • Experience working across all phases of R&D including discovery, pre-clinical, clinical development and post-marketing life cycle management required.
  • Must have demonstrated experience progressing biologics to licensure.
  • Requires significant experience with methods used for structural characterization.
  • Must have a solid understanding of how development teams support multiple therapeutic areas including infectious diseases, inflammation, and oncology is essential. 
  • Experience leading and developing a diverse team of 50+ staff members is highly preferred. 

If interested, please email your resume as a Word attachment to us, reference 3902.  No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.