Senior Director, Drug Product Manufacturing
Skills
- Clinical and commercial injectable formulation development (liquid, lyophilized)
- Aseptic sterile fill-finish operations and vendor oversight
- Tech transfer, scale-up and PPQ execution under cGMP
- Experience managing CDMO relationships and external manufacturing networks
- Knowledge of CMC requirements for IND/BLA/NDA and post-approval changes
- Familiarity with analytical methods supporting manufacturing and QC
- Strong project management and schedule coordination skills
- Proficiency in MS Excel and experience with Smartsheet, Visio, ERP systems and Power BI
- Excellent cross-functional communication and leadership skills
- Ability to manage multiple programs in a fast-paced environment
Responsibilities
- Serve as subject matter expert for drug product formulation, container-closure systems, and sterile fill-finish (including lyophilization and other injectables).
- Act as primary point of contact and working team leader with CDMOs, directing strategic reviews and managing vendor performance.
- Lead tech transfer, scale-up, PPQ planning/execution and cGMP manufacturing activities for clinical and commercial drug product.
- Ensure uninterrupted drug product supply for clinical studies and drive production plan execution from PO through delivery.
- Contribute drug product sections for INDs, BLAs, NDAs and IMPDs and support CMC regulatory interactions.
- Collaborate cross-functionally with CMC, QC, QA, Clinical Operations, Legal and Strategic Sourcing to resolve supply, quality and contractual issues.
- Develop and implement long-term external manufacturing strategies to create a reliable, cost-effective network.
- Champion a culture of quality across internal teams and external manufacturing partners and ensure regulatory compliance of manufacturing documentation.
- Provide leadership, mentorship and cross-functional communication to support program timelines and launch readiness.
Education
- Bachelor’s degree in science, chemical engineering or related field with 12+ years relevant experience
- Advanced degree (MS/PhD) with a minimum of 8 years relevant experience
Benefits
- Competitive salary and potential equity/stock compensation
- Comprehensive medical, dental and vision benefits
- 401(k) plan and retirement benefits
- Paid time off and company-observed holidays
- Parental leave and family support programs
- Professional development and training opportunities
- Collaborative, mission-driven culture
Average salary estimate
If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.
UAMS seeks an experienced Access Coordinator III to manage complex patient scheduling, insurance verification, registration, and billing issues for the Women's & Infants Service Line while training and supporting junior access staff.
CompStak needs a detail-oriented part-time Office Manager to oversee NYC office operations, vendor relationships, receptionist duties, and company event support on a 9–15 hr/week schedule.
Lead a Monro retail auto and tire center in South Euclid as the Store Manager, driving sales, coaching teammates, and delivering exceptional guest service.
The Children's Place is hiring a part-time Store Lead in Cedar Hill to lead daily store operations, coach team members, and ensure outstanding customer experiences.
Lead store operations and a team at Domino's Pittsburg location as General Manager, owning cost controls, staffing, customer experience and profitability.
Scholastic seeks a remote Fleet Planner to optimize routing, ensure DOT compliance, and improve transportation efficiency while collaborating across Distribution, Operations, and Sales.
Damar Foundation seeks a hands-on Operations Director to oversee gift processing, Raiser’s Edge database administration, annual fund activities, and foundation operations supporting individuals with I/DD and autism.
Lead warehouse operations and installer coordination for Universal Windows Direct in Indianapolis, ensuring smooth material flow, accurate CRM records, and excellent customer experience.
Lead administrative operations for a leading law firm's Los Angeles offices, managing staff, vendors, facilities, and regional coordination across multiple offices.
Lead the Sedro Woolley Domino's as General Manager, overseeing daily operations, team development, and store profitability.
Support store operations at TJ Maxx by leading receiving and merchandising efforts, training associates, and maintaining an organized, customer-ready sales floor.
Join D.A. Davidson's Great Falls branch as an Operations Associate - Margin Cashier to perform cashiering, back‑office processing, and administrative support in a compliance‑focused financial services environment.
Drive operational excellence and profitability as the General Manager for MBR Management's Decatur Domino's franchise, leading teams and executing strategic initiatives.
🔮
Hi, I'm Risa! Your AI Career Copilot
you, just ask me below!
