Director, Process Research & Development

Regular Full-Time Senior Management Boulder, CO, US

Salary Range: $ To $ Annually

Corden Pharma is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical and biotech companies manufacture medicines with the ultimate goal of improving people’s lives.

Our network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms:
Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well-being.

Our People Vision

We strive for excellence. We share our passion. Together, we make a difference in patients' lives.

Provides strategic Technical leadership and management for the Process R&D Department at the Corden Pharma Colorado site. Responsibilities include setting and achieving objectives consistent with site strategy, technical leadership for the development of peptides small molecules APIs. Developing and monitoring plans to meet outlined objectives, building employee capabilities consistent with site needs, and embedding continuous improvement in our day-to-day activities.

Provides Process R&D leadership to drive high performing Development teams, effective cross-collaboration with other departments, and inspire confidence in site’s technical capabilities.

Ensures that standard work and tactical plans for Development activities are organized and results are achieved, consistent with customer expectations and site objectives. The Process R&D Department is responsible for technical support of plant operations that include troubleshooting beyond operations capabilities and substantial process improvements. This position requires hands-on expertise managing large teams in a CDMO environment, with deep technical knowledge of peptides, peptides related products processes, and know-how.

Drive best practices through active participation across site R&D Development strategy and plan.

Member of the Development organization’s Leadership Team responsible for sustainable profitable growth.

Include the following. Other duties may be assigned.

• Responsible for technical and managerial leadership of Process R&D’s project portfolio. Ensures R&D meets customer expectations on budget and on time for the technical aspect of the projects; including route evaluation, process development, analytical development, and process characterization
• Responsible for Process Chemistry
• Responsible for technical evaluation of new projects; including identification of risks, innovation opportunities, capabilities needed, cost analysis, and pricing strategy.
• Devise and execute long-term process development strategies that are aligned with the program’s commercialization and regulatory timelines
• Provide written and verbal communication to customers to ensure confidence in ability to deliver on projects. Participate in customer meetings providing strategic direction to cross functional teams
• Lead Process Development of early to late-stage peptide products portfolio and small molecules API, managing development, process optimization and process scaleup delivering on processes suitable for large-scale manufacturing
• Ensure Process R&D capabilities align with strategic goals and provide competitive advantage. Ensure the proper technical resources and skills are in place and appropriately applied to meet and exceed Development goals. Provide access to…