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Associate Director, Analytical Development

๐Ÿ•’ 24 days ago
Analytical ChemistryPharmaceutical SciencesInhalation Drug DevelopmentCgmp Compliance

๐Ÿ“œ Description

  • Design and lead late-stage characterization of inhalation critical quality attributes, including delivered dose and particle size distribution.
  • Develop inhalation product control strategies linking analytical methods, specifications, and device performance to product quality attributes.
  • Define and support control strategies aligned with regulatory guidances.
  • Support comparability assessments for process, formulation, or supplier changes.
  • Develop and approve validation protocols and ensure compliance with global regulatory expectations.

๐Ÿ› ๏ธ Requirements

  • Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or related discipline preferred.
  • Master's degree with significant industry experience will also be considered.
  • 8+ years of analytical development experience in biotech/pharma required.
  • Experience with inhalation drug development is desirable.
  • Strong experience in cGMP late-stage development and commercial manufacturing.
  • Demonstrated experience with analytical method development and validation.
  • Lead development, optimization, qualification, validation, and lifecycle management of analytical methods for drug substances and inhalation products.

โœจ Benefits

  • Competitive salaries, a rewarding bonus program, and long-term incentive opportunitiesโ€‹
  • Enjoy flexible schedules and remote work options that support a healthy work-life balanceโ€‹
  • Comprehensive medical
  • Dental
  • Vision coverage
  • AD&D benefitsโ€‹
  • Includes vacation days
  • Sick and medical leaveโ€‹
  • Tuition reimbursement
  • Leadership trainingโ€‹
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