Director, Clinical Manufacturing

Semnur Pharmaceuticals, Inc.•Palo Alto, CA

34d•$176,000 - $250,000•Onsite

About The Position

The candidate reports to the Chief Technical Officer and is accountable for oversight of external GMP manufacturing and process validation of late-stage clinical drug products to support Chemistry, Manufacturing and Control requirement for regulatory submissions of combination products. The successful candidate will provide technical leadership and support for scale up, process validation and manufacturing activities of drug Control/Verification, commercial manufacturing service agreements with contract manufacturers, commercial manufacturing and packaging, shipping, supply chain, cross-functional teams, and review/authoring of CMC reports and associated regulatory filings to CDER (Part 210/211) and CDRH (Part 820). The ideal candidate will be a seasoned pharma/biotech with a strong record of accomplishment in Commercial cGMP Manufacturing or Late-Stage Clinical Manufacturing of small molecule or biological products and medical devices using global CMO/CDMO.

Responsibilities

Develop, implement, and maintain GMP manufacturing, process validation-PV/process performance qualification-PPQ and product development for commercial and clinical drug products at external manufacturing sites.
SAT/FAT for manufacturing and equipment.
Devise control, design verification, risk management, design history files for medical devices.
Combination products of drug products and medical devices (Part 210, 211, 820).
Review CDMO/CMO manufacturing services agreements and support quality agreements.
Oversee FMEX, PV/PPQ, GMP manufacturing and packaging for late-stage clinical drug products.
Manage supply chain for commercial and clinical drug products.
Support analytical testing for drug substances and drug products for clinical and commercial drug products.
Support Manufacturing related CMC Department Budget and interactions with Finance Department for Budget Reviews.
Ensure GMP compliance of manufactured drug substance, drug product, labeling, and packaging of commercial products and clinical products and raw materials.
Support Part 820 requirements.
Provide manufacturing oversight of Contract Manufacturing Development Organizations (CDMOs/CMOs), Contract Laboratories, 3rd Party Logistics (3PL) providers and other contracted vendors used for commercial and clinical products.
Support supply chain and logistics for commercial and clinical products.
Oversee and review/approve development protocols/reports, PV/PPQ, MBRs and EBRs and final product disposition.
Support and collaborate with Quality Assurance for investigation and resolution of product complaints with external party.
Review of commercial and investigational product complaints.
Support and collaborate with Quality Assurance for supply chain and logistics and return product’s disposition/destruction at a 3PL.
Review/author/approve CMC reports and associated regulatory filing documents, as required.
Review/approve deviations, OOSs/OOTs, Change Controls, CAPAs and any other related Quality records.
Review/approve product specifications, test methods, qualification/validation protocols and reports.
Contribute to identifying compliance risks, perform risk management, and implementing risk mitigation, as applicable.
Monitor, track, and trend stability data and GMP quality systems and establish metrics.
Contribute to GMP audit activities for DS and DP, including vendor qualifications, establishing audit schedule, conducting audits, reviewing an audit report, and closing out audits.
Support internal and external audit program including vendor qualification and routine or for cause audits and inspection readiness at CDMO/CMO, 3PL, and Vendors.
Support systems and procedures required for GMP compliance and FDA 21 CFR-Part 11.
Support product quality documentation system by writing, reviewing, approving and updating quality assurance procedures.
Perform other duties as required.