Ethos is hiring a Manager, Drug substance, Commercial Manufacturing Operations

TensorOps is hiring a Manager, Drug Substance, Commercial Manufacturing Operations to be the key technical and operational lead for our active pharmaceutical ingredient (API) manufacturers and regulatory starting material (RSM) suppliers. You will manage oversight of commercial routine manufacturing, technical transfers, and quality events to ensure the delivery of API for BridgeBio programs.

What You'll Do

• Manage commercial API CMOs and RSM suppliers from raw material ordering oversight through manufacturing and release, collaborating across CMC functions.
• Hold teleconferences with CMOs and suppliers; take minutes, track action items, and create workflows for complex CMC procedures.
• Ensure delivery of API on time and in full according to supply plans.
• Lead or support documentation review and approval (MBRs, specs, methods), change controls, and batch disposition.
• Oversee investigations related to deviations and complaints, evaluating impact on product and processes.
• Manage the timely closeout of investigations with proper root cause analysis and establishment of CAPAs.
• Create and disseminate technical transfer information and documents for CMO feasibility, transfer, validation, and routine manufacturing.
• Identify and lead key process problem resolution and process improvement initiatives.
• Partner with QA/RA CMC functions to develop and operate CMC procedures, ensuring product meets quality standards and filed parameters.
• Work closely with the supply chain group to design production schedules that maximize efficiency.
• Support authorship, review, and response to queries for Module 3 drug substance sections of the CTD.
• Create a culture of continuous improvement and high-performance teamwork.

What We're Looking For

• Ph.D. in a relevant field like organic chemistry with 2+ years of experience, or BS/MS with 5+ years of relevant process chemistry experience.
• Demonstrated track record in commercial API CMO management or experience within a CMO in commercial manufacturing (industrial-scale chemistry/engineering knowledge; plant experience is a plus).
• Experience in chemical development, process validation, and tech transfer supporting marketing applications.
• Working knowledge of modern analytical methods for small molecule drug substance.
• Project leadership experience with cross-functional CMC involvement.
• Ability to effectively interface with internal staff and build strong work relationships while working independently through tools like SharePoint, MS Teams, and Veeva.
• Familiarity with FDA and ICH guidelines, with a focus on ICH Q7 and a thorough understanding of cGMP and regulatory requirements.
• Understanding of supplier performance management (KPIs, quality metrics, adherence to agreements) and metric selection, measurement, and analysis.
• Self-motivated with strong attention to detail, time management skills, and excellent oral and written communication.

Technical Stack

• SharePoint
• MS Teams
• Veeva

Benefits & Compensation

• Market leading compensation.
• Hybrid work model valuing flexibility but encouraging office time for culture and collaboration.
• Career development through regular feedback, continuous education, and professional development programs.
• Recognition of strong performance with financial rewards, peer-to-peer recognition, and growth opportunities.

Work Mode

This role is local-country in the Netherlands.

TensorOps is an equal opportunity employer.