Executive Director, External Manufacturing

The Executive Director of External Manufacturing & Supply Chain is responsible for designing, implementing, and leading Context Therapeutics’ global external manufacturing and clinical supply network. Operating within a fully outsourced model, this role provides strategic and operational leadership across Contract Development and Manufacturing Organizations (CDMOs), Contract Manufacturing Organizations (CMOs), external testing laboratories, and supply chain partners. The Executive Director will ensure robust, compliant, and uninterrupted supply of clinical materials while building a scalable external network capable of supporting pivotal trials and future commercialization.

This individual will serve as the company’s senior leader for CMC technical development functions and will partner closely with Quality, Process & Analytical Development, Clinical, and Regulatory teams to ensure operational excellence across the development lifecycle.

This position is based out of our headquarters in Philadelphia, PA with at least 2 days per week in the office.

Responsibilities

 Job Responsibilities include, but are not limited to:

  • Develop and execute the external manufacturing and supply strategy, ensuring robust, compliant, and reliable supply of starting materials, drug substance, and drug product.

  • Lead and govern CDMO/CMO relationships, including performance management, escalations, business reviews, issue resolution, and alignment to CMC program timelines.

  • Select, qualify, negotiate, and manage contracts and scopes of work with external manufacturers, suppliers, and logistics partners using structured, risk‑based frameworks.

  • Oversee end‑to‑end clinical supply chain operations, including forecasting, sourcing, inventory management, cold-chain logistics, packaging/labeling, and global distribution.

  • Ensure successful external tech transfers in partnership with Process & Analytical Development, enabling phase‑appropriate scale‑up and manufacturing readiness.

  • Maintain GxP‑compliant operations across the external network, partnering closely with Quality and Regulatory to ensure inspection readiness and support CMC regulatory submissions.

  • Drive supply continuity and risk mitigation, including safety stock strategies, redundancy planning, monitoring of critical materials, and proactive vendor oversight.

  • Establish and monitor KPIs and operational dashboards to track delivery, cost, quality, adherence to plan, capacity, and vendor performance; lead continuous improvement initiatives.

  • Collaborate cross‑functionally (Quality, Regulatory, Clinical, CMC, Finance) to ensure clinical trial readiness, comparator sourcing (as needed), and program‑aligned supply execution.

  • Build and lead a high‑performing External Manufacturing & Supply Chain team, fostering a culture of accountability, operational excellence, transparency, and collaboration.

Requirements

  • 15+ years of experience in Technical Operations, External Manufacturing, CMC, or Supply Chain roles in biotech or pharmaceutical companies; experience with biologics strongly preferred.

  • Demonstrated leadership in managing CDMOs/CMOs, including clinical and commercial manufacturing oversight.

  • Proven experience with clinical supply chain operations, including packaging/labeling, logistics, and global distribution.

  • Strong understanding of CMC lifecycle, tech transfer, supply chain planning, and late‑phase readiness.

  • Expertise in outsourcing strategy, contract negotiation, and supplier performance management.

  • Excellent communication skills with the ability to influence internal teams and external partners.

  • Bachelor’s degree in engineering, life sciences, supply chain, or a related field; advanced degree preferred.

  • Travel required to CDMOs, suppliers, and clinical logistics partners.

About Context Therapeutics®

Context Therapeutics Inc. (Nasdaq: CNTX) is a biopharmaceutical company advancing T cell engaging (“TCE”) bispecific antibodies for solid tumors. Context is building an innovative portfolio of TCE bispecific therapeutics, including CTIM-76, a Claudin 6 x CD3 bispecific antibody, CT-95, a Mesothelin x CD3 bispecific antibody, and CT-202, a Nectin-4 x CD3 bispecific antibody. Context is headquartered in Philadelphia

Context Therapeutics is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.