Sr. Manager/Associate Director, Pre-formulation Development

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Responsibilities:

  1. Manage Pre-formulation group, work closely with Process group and Formulation group to meet project timelines, departmental goals.
  2. Plan, co-ordinate and oversee the work activities of Polymorph screening, Salt screening and selection, Solid state characterization (PXRD, TGA, DSC, Microscopy, etc.), Solubility determination, Particle size analysis, Recrystallization, pKa determination.
  3. Support Process group to control particle size of API with recrystallization and milling.
  4. Support Formulation group to develop new formulations for poorly soluble compounds(such as nano-particles, solid dispersion, microemulsion) to improve bioavailability.
  5. Quick adapt to new technology and be a technical leader in certain areas.
  6. Prepare document (Pre-formulation part) for IND and NDA filling.

Qualifications:

  1. D. (or equivalent) in Chemistry, Pharmaceutical Sciences, Chemical Engineering or closely related field preferred.
  2. 8+ years’ experience in the pharmaceutical or biotech industry.
  3. Strong technical knowledge of pre-formulation development. Working knowledge of process scale-up and technology transfer, cGMPs, ICH guidelines.
  4. Excellent interpersonal skills in internal and external (i.e. CMO/CRO management) interactions.
  5. Excellent communication skills both written and oral.
  6. Excellent time and project management skill.