Associate Director, Analytical Development And Quality Control

Kailera

Waltham, MA, US
$155,000—$190,000 usd; not specified; comprehensiv...
On-site (3-4 days per week)
Analytical methods and control strategies
Peptide drug substances and drug products
Analytical transfers and troubleshooting
Kailera is seeking an Associate Director of Analytical Development and Quality Control who will support the analytical development and quality control operations for their therapeutic pipeline, particularly in peptide drug substances and products. The ideal candidate will possess significant experience in the pharmaceutical or biotech industry, particularly in innovative drug development and regulatory filings

Job Summary

  • The Associate Director, Analytical Development and Quality Control will support analytical development and QC operations for clinical development and commercialization of Kailera’s pipeline compounds.
  • Support analytical development and QC activities related to characterization of peptide drug substances and drug products from early-stage clinical development through commercialization.
  • This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity.

Matching Summary

Match Score: 85

Kailera is seeking an Associate Director of Analytical Development and Quality Control who will support the analytical development and quality control operations for their therapeutic pipeline, particularly in peptide drug substances and products. The ideal candidate will possess significant experience in the pharmaceutical or biotech industry, particularly in innovative drug development and regulatory filings.

Salary

$155,000—$190,000 USD; Not specified; comprehensive health coverage, flexible time off, paid holidays, year-end shutdown, wellness stipend, 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, annual bonus opportunities, equity grants

Skills & Requirements

Must-have

  • analytical methods and control strategies
  • peptide drug substances and drug products
  • analytical transfers and troubleshooting
  • authoring of relevant CMC sections
  • oversight of analytical activities at CDMOs

Nice-to-have

  • innovative team-player
  • high energy for dynamic company
  • collaborative and inclusive workplace

Key Requirements

  • Bachelor's degree and 10+ years of experience or advanced degree with 5+ years
  • Knowledge of peptide chemistry required
  • Experience in authoring regulatory documents
  • Knowledge of cGMP, quality systems, ICH guidelines
  • Experience with oversight of analytical activities at CDMOs/CTLs

Work Rights

Not specified

Tailored Resume

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