Aequor

Compensation

Full Description

Role: CMC Project Manager Senior Location: Thousand Oaks, CA/Remote Duration: 24+ Months (Possible Extension) • • Pharmaceutical Product Development & CMC Strategy • • Technology Transfer and CDMO Management • • Biological Drug Substance Manufacturing • • Small Molecule Drug Product Development & Manufacturing Skills & Experience in: • Project Management and Lifecycle Management Support for clients’ Sterile Fill/Finish Drug Products in the cGMP CDMO manufacturing facility. • Formulation & Process development, and cGMP manufacturing of semi-solid drug products. • Authored technical documents including batch records, material and product specifications, SOPs. • Authored CMC sections of INDs, ANDAs, and NDAs submissions • Managed CMC teams and ensured seamless integration of CMC deliverables into program milestones for early and late-stage programs, providing drug product for clinical supply and commercial launch. • Led cross-functional teams for technology transfer, process development, and manufacturing of drug substances and drug products, including small molecules and biologics, ensuring quality and regulatory compliance. • Prepared CMC sections for various regulatory submissions (IND, IMPD, NDA, J-NDA, BLA), ensuring compliance with guidelines and timely submission. • Collaborated with internal stakeholders and external partners/CMOs. • Developed program plans utilizing Smartsheet, MS Project. Utilized Planisware for budget and resource tracking. • Led weekly client meetings, provided minutes and action item updates, and developed project plans. • Led departmental initiatives for improved efficiencies including: 1) Standardized CMC development roadmap by delivering a MS Project template, and 2) Procedural zed CMC Governance process through creation of a playbook.