Antheia

Antheia

Senior Quality Control Manager

Menlo Park, CA · Senior · Part-time

Sponsorship not specified$160k-$195kDetected 44 days ago
ComplianceProduct ManagementSupply ChainPublic HealthGMPFDA RegulatoryMass SpectrometryLeadershipCommunicationMentoring

About the role

  • About Antheia: Antheia is the advanced biosynthesis company transforming pharmaceutical manufacturing and innovation for the 21st century.
  • Duties, responsibilities and activities may change or new ones may be assigned at any time with or without notice.
  • Please note that Antheia doesn't discriminate based on age, race, ethnicity, national origin, religion, gender, sexual orientation, disability, medical history, and other non-merit characteristics.

Responsibilities

  • We're looking for a Senior QC Manager to own quality control across our GMP and non-GMP environments, from R&D through commercial manufacturing.
  • You'd lead a team of QC Analysts and Specialists, serve as the primary interface with our CDMO and contract lab partners, and build the systems and processes that scale with us as we grow.
  • What You'll Own

Requirements

  • Solid experience in OOS/OOT investigations, deviation handling, and CAPA implementation.
  • Familiarity with laboratory systems such as LIMS, Empower, and ELNs.
  • This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee.
  • Legal authorization to work in the United States is required.
  • In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire..
  • Bachelor's or Master's degree in Chemistry, Biology, or related field. Advanced degree preferred.
  • Deep knowledge of chromatographic (HPLC, GC), spectroscopic (UV/Vis, FTIR), and wet chemistry techniques; bioanalytical familiarity is a plus.
  • Strong background in method development, validation, and lifecycle management (ICH Q2, Q14).
  • In-depth understanding of FDA, EMA, and ICH regulatory expectations; prior audit experience highly desirable.
  • Excellent written and verbal communication skills with ability to lead cross-functional teams and interface with regulatory agencies and partners.

Nice to have

  • Ensure compliance with GMP, ICH, USP/EP, and FDA/EMA standards across all applicable testing
  • Serve as the primary QC point of contact for CDMOs, CROs, and contract testing labs
  • Review and approve analytical packages, protocols, and reports from third parties for regulatory compliance and data integrity
  • Ensure data integrity across workflows (ALCOA+ principles, LIMS, Empower, ELNs)
  • Contribute to vendor selection, lab qualification, and capital planning
  • Bachelor's or Master's degree in Chemistry, Biology, or related field.
  • Advanced degree preferred.
  • 10+ years of progressive experience in pharmaceutical QC under GMP regulations, with 5+ years in a leadership or managerial role.

Compensation

  • Comprehensive compensation package, which includes annual bonus potential and equity opportunities
  • Menlo Park Labs free shuttle service to CalTrain, BART Station, and SF
  • $160,000 - $195,000 + annual bonus + equity in a high-growth company
  • This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee.
  • Duties, responsibilities and activities may change or new ones may be assigned at any time with or without notice.
  • In addition, Antheia prohibits the harassment of any individual on any of the bases listed above or any other characteristics protected under federal, state, or local laws.

Benefits

  • Our cross-functional team shares a vision for the future: improved pharmaceutical supply chains that can end drug shortages and drive equitable access to essential medicines.
  • Base salary: $160,000 - $195,000 + annual bonus + equity in a high-growth company

Company info

  • Part-time ( temporary roles are not eligible for Company sponsored benefits.
  • The company provides its global pharmaceutical customers with a resilient, efficient supply of critical ingredients at scale, while expanding the innovation frontier for new therapeutic development.
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This listing is sourced directly from Antheia's careers page and normalized into a canonical job model.