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Senior/Principal Scientist, Analytical Development (REMOTE)

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Posted a month ago United States Salary undisclosed
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Job Description

Position Summary:

We are seeking a Senior Scientist, Analytical Development to join our Analytical team.
Position can be fully REMOTE.

Lead and support Analytical Development activities related to analytical method development, product characterization and comparability assessment for multiple early-stage and late-stage programs of ADCs, mAbs and fusion proteins. This role will report to the Director of Analytical Development.
  • Work in a team environment to manage and co-ordinate analytical development activities between contract testing labs, CMO and internal.
  • Develop, improve, and implement platform methodology for release/stability and characterization testing for our products
  • Manage product characterization and analytical comparability assessment activities
  • Author and review analytical documents including but not limited to protocols, reports, procedures and certificates
  • Write and review analytical sections in regulatory submission documents (e.g. IND, IMPD, BLA)
  • Work closely with Quality Control in analytical method implementation, qualification/validation, and transfer. Serve as a technical expert to aid in analytical investigations and assay trouble shooting in routine GMP Quality Control testing.
  • Be a key member of the interdisciplinary CMC project teams.
  • Bachelor's degree required. Prefer candidates with a Master's and/or PhD in Biochemistry, Chemistry, a BS/MS degree
  • 5+ years of industry experience in (bio-) pharmaceutical manufacturing and testing
  • 5+ years' experience in Mass spectrometry, chromatography (e.g. SEC, RP-HPLC, IEX), and capillary electrophoresis (e.g. icIEF, CE-SDS) techniques for protein therapeutics
  • Experience with structural characterization of both large and/or small molecules
  • Experience in analytical method development and qualification/validation for GMP quality control testing
  • Experience with antibodies, highly potent cytotoxic active pharmaceutical ingredients and/or antibody-drug conjugates is a strong plus
  • Hands-on experience with outsourcing of assay development, stability and quality control in support of CMC activities
  • Knowledge of regulatory environment (ICH/FDA/EMA regulations) and experience with organizing and writing regulatory submissions
  • Excellent communication skills for both written and verbal presentations
  • Strong and proven leadership capabilities related to project management
  • Self-motivation, enthusiasm and ability to interact within a multi-disciplinary team across multiple locations.
  • Ability to articulate issues to management in a timely manner
  • Experience in working in entrepreneurial stage companies
  • Demonstrable ability to work proactively and independently, tenacious when necessary.
  • Self-motivated, goal-driven with a pragmatic, hands-on approach.
  • Positive, professional team member
  • Strong organizational skills
  • High-quality standards
  • Excellent oral and written communication skills.
  • Creative problem-solving skills.