Head of Analytical Development (Reading)

Compensation

: $94,360.00 - $141,170.00 /year *

Employment Type

: Full-Time

Industry

: Scientific Research



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Major tasks and responsibilities will include:

  • Leads phase-appropriate analytical development strategy for all live biotherapeutic product candidates within the CMC function.
  • Serves as a member of a dynamic and motivated Development team to bring novel medicines to clinical trials and commercialization.
  • Provides critical expertise on a cross functional CMC team.
  • Provides strategic and scientific guidance for the analytical development of novel drug substance and drug product.
  • Leads the development of cell-function relationships and analytical characterization to define critical quality attributes of the drug substance and drug product.
  • Supports the development of analytical correlations to process variables and recommends PAT strategies as appropriate.
  • Builds an in-house testing group to support high-throughput testing of internal process and formulation development samples.
  • Implements assay automation as needed.
  • Leads the test method generation, tech transfers, and validation to support GMP manufacturing.
  • Provides analytical guidance to support manufacturing investigations.
  • Leads the analytical development function in the preparation of technical reports.
  • Leads the analytical sections of regulatory submissions, participates in their review and approval, and contributes to the development of strategies to comply with US and international regulatory standards.
  • Communicates assay development project objectives, advances, challenges, and timelines to project teams.
  • Advances scientific and regulatory approaches for LBPs via active participation and leadership across industry trade groups and conferences.
  • We seek candidates with the following qualifications:

  • Ph.D. in microbiology, biochemistry, or related discipline required.
  • Must have 12+ years of experience in biopharmaceutical analytical development, licensure and post-marketing support
  • Requires in-depth experience and knowledge of biological analytics and microbiological assays.
  • Must have understanding of the processes and functions involved in biologics drug development and life cycle management.
  • Requires the demonstrated ability to develop and transfer test methods for biologics manufacturing.
  • Experience with regulatory submission writing and review required.
  • Must have a proven track record in leading scientific teams, including direct and/or indirect people management experience.

  • Associated topics: antibody, biopharma, biopharmaceutical, clinical, immunohematology, industrial hygienist, injury, pharmacology, therapy, toxicologist * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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