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Sr. Manager/Associate Director, Analytical Development & Quality Control

Genezen
Location
Indianapolis, IN
Posted
1 month ago
Department
Quality Control
What they actually want (must-haves)
  • BS in Molecular Biology, Biochemistry, Chemistry or related field
  • Minimum 4 years in a leadership role
  • Minimum 8 - 10 years progressive experience in analytical development, quality control, or related discipline within biopharma or CDMO environments
  • Extensive experience supporting viral vector products across clinical development phases and regulatory submissions
  • Demonstrated success leading analytical development, method validation, and QC Operations in a cGMP environment
  • Strong understanding of analytical methods used for viral vector characterization including: qPCR and ddPCR, ELISA, Flow cytometry, Cell-based potency assays, Genome integrity assays, Empty/full capsid analysis
Nice to have
  • MS in Molecular Biology, Biochemistry, Chemistry or related field
What the job really is

The Senior Manager/Associate Director of Analytical Development & Quality Control at Genezen will lead scientific and operational efforts in analytical development and quality control for viral vector programs. This role involves managing method development, overseeing QC laboratory operations, ensuring regulatory compliance, and fostering collaboration across various departments to support program needs and GMP execution.

Benefits
  • Paid vacation days, amount based on tenure
  • Paid sick time
  • 10 observed holidays + 2 floating holiday + 1 volunteer day
  • 401(k) plan with company match up to 6% of salary
  • Share Appreciation Rights
  • Choice of several healthcare plans
Things to weigh
  • No salary listed
  • The role requires working in a BSL 2 environment with personal protective equipment/aseptic gowning
  • The position involves oversight of both QC and indirect leadership of Analytical Development, which may lead to a broad scope of responsibilities
  • The job may require occasional exposure to hazardous conditions and high noise levels
Job score3.8/5
Benefits5/5
Freshness4/5
Career value5/5
Role clarity5/5
Pay transparency0/5

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