Sabin Vaccine Institute logo
Sabin Vaccine Institute

We are a global health non-profit on a mission to make vaccines more accessible, enable innovation & expand immunization

Senior Manager, CMC Analytical Sciences

ManagerManagerFull TimeRemoteSeniorTeam 51-200Since 1993H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

8 days ago

Salary

$145K - $160K / year

Seniority

Senior

Bachelor Degree9 yrs expEnglish

Job Description

Senior Manager, CMC Analytical Sciences

Sabin Vaccine Institute

• Direct analytical activities conducted by external laboratories and contract development and manufacturing organizations (CDMOs) • Provide expert technical leadership in CMC analytical sciences including development, qualification, validation, and transfer of analytical methods • Collaborate cross-functionally to ensure analytical strategies meet regulatory expectations • Lead and oversee ICH-compliant stability programs including forced degradation studies • Compile, review, and analyze analytical data in support of development programs

Job Requirements

  • Bachelor’s degree in biochemistry, chemistry, biology, chemical engineering, or related pharmaceutical science required; advanced degree preferred
  • 9+ years of experience in biopharmaceutical product development, including management of CMC analytical activities
  • Experience in vaccines, cell therapy, or gene therapy strongly preferred
  • Demonstrated experience overseeing CDMOs and/or managing remote external analytical activities
  • Strong technical expertise in biologics and/or vaccine development
  • Hands-on experience with analytical techniques such as qPCR/RT-PCR, HPLC, ELISA, mass spectrometry, light scattering, and cell-based potency assays
  • Proven ability to define and justify Critical Quality Attributes (CQAs)
  • Experience supporting GMP manufacturing process characterization strongly preferred
  • In-depth understanding of US and EU CMC regulatory requirements
  • Comprehensive working knowledge of current Good Manufacturing Practices (cGMPs)
  • Experience authoring CMC sections for INDs, NDAs, BLAs, and ex-US regulatory submissions
  • Strong attention to detail with excellent organizational and problem-solving skills
  • Willingness to travel domestically and internationally as needed

Benefits

  • Comprehensive benefits package including medical, dental, and vision coverage
  • Flexible spending accounts
  • Flexible vacation and sick leave
  • Employer-paid life and disability insurance
  • Observance of 11 federal holidays
  • End-of-year winter break
  • Employer-matching 401(k) plan

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