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Senior Manager, Analytical Development Lead

2 months ago

Plymouth Meeting, Pennsylvania, United States Harmony Biosciences LLC Full time
Job Summary

We are seeking a highly skilled Senior Manager, Analytical Development to join our team at Harmony Biosciences LLC. As a key member of our Technical Operations organization, you will play a critical role in supporting the development and manufacturing of pharmaceutical drug products.

Key Responsibilities
  • Lead analytical development activities for multiple drug substance and drug product contractors, ensuring compliance with regulatory requirements and industry standards.
  • Develop and implement analytical methods for clinical and commercial programs, including method development, method improvements, and method validation.
  • Provide technical oversight and guidance to Contract Organizations (COs), ensuring they meet quality and compliance standards.
  • Collaborate with cross-functional teams to define analytical testing strategies and develop technical aspects of quality agreements.
  • Manage laboratory deviations and investigations, ensuring timely and effective resolution.
  • Oversee release testing and stability programs for drug substance and drug product, working closely with Quality Assurance.
  • Drive quality and compliance initiatives, ensuring COs meet Harmony business objectives.
Requirements
  • Bachelor's Degree in analytical chemistry, pharmaceutical sciences, or a related field; MS or PhD preferred.
  • 6+ years of experience in analytical method development and validation within the pharmaceutical industry.
  • Technical proficiency in analytical method development, including dissolution testing, chromatographic techniques, and spectroscopy methods.
  • Knowledge of regulatory environment (FDA/ICH regulations) and experience with organizing and writing regulatory submissions.
  • Knowledge and demonstrated mastery of current Good Manufacturing Practices (cGMPs) and associated quality guidance and principles.
What We Offer
  • Medical, Vision, and Dental benefits.
  • Generous paid time off and Company-designated Holidays.
  • Company-paid Disability benefits and Life Insurance coverage.
  • 401(k) Retirement Savings Plan.
  • Paid Parental leave.
  • Employee Stock Purchase Plan (ESPP).
  • Company-sponsored wellness programs.
  • Professional development initiatives and continuous learning opportunities.