Drug Product Lead & CMC Project Manager

Ensure advancement for small molecule program

As Drug Product Lead & CMC Project Manager, you will report directly to the Senior Director, Head of Chemical and Pharmaceutical Development and play a crucial role in the CMC department. This hybrid role combines technical leadership in drug product development with strategic project management responsibilities for a Phase II small molecule program advancing into Phase III. The Drug Product Lead & CMC Project will provide end-to-end leadership of drug product development activities, while also coordinating cross-functional CMC efforts, ensuring delivery of high-quality outcomes aligned with regulatory, clinical, and business objectives. You will serve as the CMC Project Manager, leading cross-functional efforts across drug substance, drug product, analytics, QA, and RA as well as ensuring alignment of timelines, deliverables, and quality while facilitating communication between stakeholders. You will lead CMC core team meetings, track progress, and proactively resolve bottlenecks to meet development and regulatory milestones. Moreover, you will act as Drug Product Lead, overseeing formulation and process development, clinical supply manufacture, technology transfer, and readiness for Phase III. Apply Quality by Design (QbD) principles, including identification of Critical Quality Attributes (CQAs), execution of risk assessments (e.g., FMEA, fishbone diagrams), and development of design space and control strategy. Ensure regulatory alignment and documentation in CMC submission sections. Additionally, the role includes leading feasibility studies in lifecycle management and actively contributing to the development of CMC processes and best practices across the organization. Finally, you will collaborate with Quality Assurance (QA), Regulatory Affairs, Analytical, Manufacturing teams, commercial, supply chain, CDMOs to align and support the development efforts with overall business strategies.

Highly skilled drug product professional with strong project management capabilities

We are seeking a highly qualified candidate with an MSc or PhD in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related field. The ideal candidate will bring extensive experience from the pharmaceutical industry, with a proven track record of leadership in drug product development and CMC project management. A solid understanding of formulation science, process development, and the clinical manufacturing of small molecules is essential.

The role requires demonstrated expertise in applying Quality by Design (QbD) frameworks, conducting risk assessments, and translating complex technical development activities into robust regulatory strategies. You should have significant experience leading cross-functional teams and collaborating effectively with external CDMOs (Contract Development and Manufacturing Organizations) and CROs (Contract Research Organizations). Strong communication, planning, and interpersonal skills are vital for success in this position, as you will work closely with both internal stakeholders and external partners to drive projects forward and ensure alignment with development goals and regulatory expectations.

Preferably, you also have experience with late-phase development and preparation for commercial manufacturing. Familiarity with lifecycle management and the development of line extension strategies is considered a strong asset. In addition, formal project management training such as PMP certificationor an equivalent qualificationis highly desirable.

Impact the future development of iron- and carbohydrate-based treatments

This is your chance to embark upon a personal and organizational journey in a dynamic company where your know-how is greatly needed for the future development of Pharmacosmos. The recruitment process is carried out by Venaris Executive Search. For more information regarding the position, please reach out to Sr. Executive Search Consultant, Lars Nordlund, on +45 3123 3018. All requests will be handled confidentially. If this position is for you, do not hesitate to apply by uploading your CV - it is not necessary to include a cover letter.

Pharmacosmos

Founded in 1965, Pharmacosmos is a global healthcare pioneer in carbohydrate chemistry and a leader in the development of innovative treatments for blood diseases, including iron deficiency anemia and cryopreservation technology. On September 18th, 2024, Pharmacosmos announced the successful completion of their acquisition of G1 Therapeutics, a commercial-stage oncology company. The acquisition aligns perfectly with Pharmacosmos' strategy by leveraging their extensive expertise in blood diseases, positioning the company for its next phase of growth and strengthening its global commercial portfolio. Headquartered in Holbæk, Denmark, Pharmacosmos employs 650 dedicated employees, with products marketed in over 40 countries worldwide. Please also visit www.pharmacosmos.com.