Director, Analytical Research & Development

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.

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

Responsibilities include setting and achieving objectives consistent with site strategy, analytical method development and validation for 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 strategic Analytical Technical leadership and management for the Analytical R&D Department at the Corden Pharma Colorado site.

Leads the design, development, and validation of analytical methods supporting peptide programs. Provides Analytical R&D leadership to drive high performing Development teams, effective cross-collaboration with other departments, and inspires confidence in site’s technical capabilities. Ensures that standard work and tactical plans for Analytical Development activities are organized and results are achieved, consistent with customer expectations and site objectives. The Analytical R&D Department is responsible for technical support of plant operations that include developing or transferring new analytical methods to support early phase clinical GMP programs, as well as validating analytical methods for late phase commercial products.

This position requires a hands-on expertise managing large teams in a CDMO environment, with deep analytical technical knowledge of peptides and peptide related products, and expertise in various analytical techniques from HPLC, UPLC, SEC, LCMS/MS, CHN, AAA, IC, ICPMS, KF, IR, Raman, etc. Drives 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 Analytical R&D’s project portfolio. Provide scientific and operational leadership and ensure Analytical R&D meets customer expectations on budget and on time for the technical aspect of the projects; including IPC method development, release methods, starting materials and regulatory starting materials testing
• Responsible for Analytical Chemistry method development and phase appropriate validation
• 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 analytical strategies that are aligned with programs 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 development, tech transfer and qualification, and validation of stability indicating methods, by looking at accuracy, precision,…