Bellus Health

Director, Analytical Development

Director, Analytical Development

Director, Analytical Development

Director
Pennsylvania, United States (Remote)
Publié il y a 5 mois

Position Summary:

Bellus is seeking an experienced and effective individual to lead the Analytical development through late-stage development and approval of BLU-5937 as well as the expansion of the Bellus pipeline. This individual will be accountable for all Analytical Development and QC activities associated to the development and manufacture of drug substance and drug product. The Director, Analytical Development will report to the Head of CMC. The Chemistry, Manufacturing and Controls (CMC) team is highly collaborative and operates virtually, with a global network of highly qualified Contract Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs). The Director, Analytical Development will work closely with the CMC team, colleagues in cross functional departments and manage the Analytical Development and QC activities at vendors.

Job Function/Responsibilities:

  • Lead analytical development and QC of small molecule API and drug product, contribute to the overall CMC strategy of drug development
  • Develop phase-appropriate quality control strategy for starting materials, intermediates, drug substance and drug products
  • Efficiently support cross functional project teams. Coordinate Analytical development and QC activities with drug substance and drug product development teams within CMC
  • Direct analytical development activities at CDMOs including identification of impurities and degradation products, reference standard qualification and physical (solid-state) characterization
  • Execute phase appropriate validation of analytical methods at CDMOs
  • SME in analytical sciences, the candidate must be able to bolster Bellus analytical development capabilities by managing the strategic and technical needs of the projects
  • Manage stability programs, maintain data room, and provide trending to determine retest of API and shelf life of DP
  • Review release/stability testing data at CDMOs and collaborate with QA for release of batches
  • Oversight/review (and author, as appropriate) Analytical related CMC sections for regulatory submissions (including INDs, IMPDs, NDAs, briefing packages or other regulatory dossiers) to support our product candidate
  • Contribute to internal quality systems
  • Identify execution risks and develop contingency plans as needed

Requirements: Education/Experience:

  • Ph.D. level in Analytical Chemistry of Pharmaceutical Sciences with 7 or more years’ pharma-relevant experience or BS/MS level with 8-10 years
  • Ability to independently manage the technical and strategic needs of multiple simultaneously advancing clinical drug candidates in a multifunctional CMC team
  • Skilled in HPLC, LC-MS, GC, GC-MS, FT-IR, UV-VIS, KF, NMR, dissolution, and broad knowledge of other techniques used in small molecule pharmaceutical and oral solid dosage form analysis
  • Expertise with physiochemical analysis and solid-state chemistry techniques for characterizing API and interpretation of data to support drug formulation or BCS determination
  • Successful track record of method development and validation of analytical testing methods to support in-process, release, and stability assessment
  • Excellent familiarity with up-to-date cGMP, ICH, and other regulatory guidelines
  • Applied experience managing drug substance and drug product long term stability plans and retest/shelf life expirationsA proven track record of implementing phase appropriate quality control strategies
  • Direct experience in managing analytical development/QC activities at CROs and CDMOs
  • Experience in authoring analytical related sections of INDs and NDAs
  • Working knowledge of cGMP regulations and ICH guidelines as well as pharmacopeia standards required; experience working in a cGMP QC environment highly desirable
  • Working knowledge of GLP/GCP regulations pertaining bioanalysis
  • Excellent analytical, communication, presentation, writing, and leadership skill
  • Experienced working in in a fast-paced entrepreneurial environment

If you are interested in being part of an innovative team and believe your profile matches the descriptions above, we invite you to send your application.

Caractéristiques de l'emploi

Catégorie emploi

Full Time

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