Director, Injectable Drug Product Development

Alexion

Base: $175,000 to $263,000; bonus/equity: short-te...
Onsite
Formulation and process development
Injectable drug product development
Drug/device combination products
Lead and direct the formulation and process development of patient-centered injectable drug products for Alexion's diverse portfolio

Job Summary

  • Lead and direct the formulation and process development of patient-centered injectable drug products for Alexion's diverse portfolio.
  • Ensure the development of portfolio projects in a phase-appropriate manner while managing the budget and your partners.
  • Provide subject matter expertise for preparing regulatory filings, regulatory interactions including inspections, audits and is accountable for the technical content of the relevant drug product sections of regulatory submissions.

Matching Summary

Lead and direct the formulation and process development of patient-centered injectable drug products for Alexion's diverse portfolio.

Salary

Base: $175,000 to $263,000; Bonus/Equity: short-term incentive bonus opportunity, equity-based long-term incentive program; Benefits: qualified retirement program, paid vacation, holidays, paid leaves, health benefits

Skills & Requirements

Must-have

  • formulation and process development
  • injectable drug product development
  • drug/device combination products
  • technology transfer
  • aseptic processes
  • high concentration protein formulation

Nice-to-have

  • patient-centered product development
  • life cycle development opportunities
  • internal and external partnerships
  • matrix team leadership

Key Requirements

  • BS or equivalent in Bio/Chemical Engineering, Pharmaceutical Sciences, Biochemistry, or related discipline
  • Years of drug product development experience in formulation and process development
  • At least 8 years of experience developing drug product for early and late-stage programs
  • At least 5 years of experience managing scientists and engineers
  • Proficient in current approaches for formulation and drug product process development
  • Knowledge of current regulatory guidelines and cGMP requirements

Work Rights

Not specified

Tailored Resume

Cover Letter