Director, Drug Product Manufacturing And Development (sterile)

Kailera

Waltham, MA, US
$196,000 - $240,000 usd py
On-site (3-4 days per week)
Aseptic drug product manufacturing
Late-stage process development
Commercial readiness initiatives
Kailera is seeking a Director of Drug Product Manufacturing and Development for its sterile drug products in Waltham, MA. The ideal candidate will have extensive experience in the pharmaceutical or biotech industry, particularly in aseptic manufacturing, and will lead initiatives from clinical stages to commercialization

Job Summary

  • Oversee drug product manufacture from clinical through commercial stages, providing technical oversight of late-stage process development for robust aseptic drug products at commercial scale.
  • Develop and design strategies for late-stage process development, scale-up, optimization, and commercial readiness for aseptic drug products manufactured by external partners.
  • The company offers comprehensive health coverage, flexible time off, paid holidays, a year-end shutdown, a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants.

Matching Summary

Match Score: 85

Kailera is seeking a Director of Drug Product Manufacturing and Development for its sterile drug products in Waltham, MA. The ideal candidate will have extensive experience in the pharmaceutical or biotech industry, particularly in aseptic manufacturing, and will lead initiatives from clinical stages to commercialization.

Salary

$196,000 - $240,000 USD

Skills & Requirements

Must-have

  • aseptic drug product manufacturing
  • late-stage process development
  • commercial readiness initiatives
  • cGMP, ICH guidelines, FDA, EMA

Nice-to-have

  • entrepreneurial spirit
  • team-oriented culture
  • innovative team-player
  • fast-paced company environment

Key Requirements

  • 10+ years experience pharmaceutical/biotech
  • Experience with vials, pre-filled syringes, cartridges
  • Experience with quality systems
  • Bachelor of Science degree required

Work Rights

Not specified

Tailored Resume

Cover Letter