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Lumicity · 1 week ago

Executive Director Analytical Development and Quality Control

United States

Full-time

Remote

Director/Executive

8+ years exp

Lumicity is a clinical-stage biotechnology company advancing small molecule programs across discovery and early clinical development. The Executive Director of Analytical Development will provide technical leadership across multiple small molecule programs, ensuring regulatory compliance and overseeing analytical development and quality control activities.

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Hiring Manager

Aaron Bacon

Responsibilities

Act as the analytical technical lead for multiple small molecule programs

Develop strategies and oversee execution of analytical activities for drug substance and drug product development and manufacturing

Lead analytical method development, transfer, qualification/validation, in-process/release/stability testing, product characterization, and specification setting

Manage internal FTEs and mentor team members to foster a culture of scientific rigor, accountability, and inclusivity

Communicate progress to internal and external stakeholders through reports and presentations

Author, review, and approve development/stability reports, specifications, SOPs, deviation/investigation reports, and relevant regulatory submission sections

Travel to CDMOs for vendor assessment, troubleshooting, qualification, and oversight of analytical testing as needed

Qualification

Analytical ChemistryPharmaceutical Industry ExperienceCGMP ComplianceCDMO ManagementQuality ControlLeadership SkillsOrganizational SkillsCommunication Skills

Required

Ph.D. in Analytical Chemistry or related field with 8+ years of pharmaceutical/biotech industry experience in analytical development and quality control for small molecules

Experience managing CDMOs and contract testing labs

Strong understanding of cGMP, quality systems, ICH guidelines, FDA/EMA requirements, and small molecule drug development from preclinical to early clinical stages

Proven leadership, organizational, and communication skills, with the ability to manage multiple priorities effectively