Senior Quality Control Manager

About Antheia:

Antheia is the advanced biosynthesis company transforming pharmaceutical manufacturing and innovation for the 21st century. Antheia’s commercially proven technology platform produces high-value pharmaceutical ingredients in a fraction of the time compared to legacy approaches while significantly reducing supply chain risk. 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. Backed by leading investors and recognized by the U.S. government as a priority technology for public health and national and economic security, Antheia is manufacturing the medicines the world needs today while enabling tomorrow’s breakthrough therapeutics.

Working at Antheia:

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. As a team, we aim to embody a culture that celebrates diversity, prioritizes knowledge sharing, encourages exploration and ideation, challenges constructively, and supports individuals in their professional and personal journeys. At Antheia, you can expect to be inspired by the science, by your teammates, and by the opportunity we have to bring about change in the pharmaceutical industry.

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

Team & Operations

• Lead and develop a team of QC Analysts and Specialists: hiring, mentoring, performance, day-to-day priorities
• Build and improve lab operations infrastructure (scheduling, resource planning, data review workflows)
• Ensure compliance with GMP, ICH, USP/EP, and FDA/EMA standards across all applicable testing

External Partnerships

• 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
• Drive resolution when external partners hit analytical issues or timeline delays

Technical Leadership

• Lead method development, transfer, and validation aligned with ICH Q2(R2) and Q14
• Own complex investigations (OOS, OOT) through root cause analysis and CAPA, with a bias toward speed and continuous improvement
• Ensure data integrity across workflows (ALCOA+ principles, LIMS, Empower, ELNs)

Strategy

• Develop QC strategies that align with product lifecycle and multi-site growth
• Contribute to vendor selection, lab qualification, and capital planning
• Support regulatory filings with accurate, complete analytical documentation

Qualifications

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.

Demonstrated experience managing QC laboratories, supervising analytical staff, and coordinating external testing activities.

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).
• Solid experience in OOS/OOT investigations, deviation handling, and CAPA implementation.
• In-depth understanding of FDA, EMA, and ICH regulatory expectations; prior audit experience highly desirable.
• Familiarity with laboratory systems such as LIMS, Empower, and ELNs.
• Excellent written and verbal communication skills with ability to lead cross-functional teams and interface with regulatory agencies and partners.