Associate Director, Process Development Drug Substance

Reporting into the Senior Director, DS development, this role will provide scientific and technical leadership for drug substance development projects at various stages of the development life-cycle. Success requires application of scientific and/or engineering principles and creativity to process design and development studies, and translation into commercially feasible, reliable and robust processes. Experience of the critical interface attributes between drug substance and drug product will be especially relevant. Activities will be performed primarily with external contract development and manufacturing organisations (CDMOs).

Other responsibilities will include cross-functional team leadership and/or membership, authoring technical reports and CMC sections of regulatory dossiers, and participation in department or functional initiatives.

The role will involve significant cross functional collaboration with other functions including Quality, CMC Regulatory, Manufacturing, and New Product & Technology Integration working towards agile new product introduction and ensuring all processes are understood, robust, efficient and in control.

The role is both project and operations orientated. It shall require an ability to drive and deliver multiple projects concurrently.

Essential Functions

• Lead the process development and cGMP manufacture of small molecule drug substances at CDMOs

• Ensure adequate supply of drug substance for clinical studies and other needs

• Oversee the development of robust and reliable manufacturing processes utilizing Quality by Design (QbD) principles.

• Oversee the synthesis of chemical entities to support clinical and non-clinical studies

• Ensure that all DS processes are in line with all applicable regulations, policies, guidelines and procedures

• Represent the drug substance team on cross functional project teams as needed

• Work closely with other cross-functional CMC project team members to deliver on agreed project goals

• Actively contribute to functional area continuous improvement initiatives

• Author and/or review drug substance sections of regulatory dossiers and technical reports

• Support other Technical Operations functions to ensure a smooth transfer of technologies and products to manufacturing sites

• Clearly and effectively communicate ideas and results, written and verbal, to technical and non-technical audiences

• Plan, budget, execute and report on assigned projects

• Develop knowledge of new pharmaceutical manufacturing processes and technologies as required in line with Jazz business objectives and share best practices within teams

Required Knowledge, Skills, and Abilities

• Strong record of achievement in drug substance development and manufacturing.

• Substantial experience required with a broad experience across drug development and manufacturing technologies but with specific experience related to drug substance chemical process development.

• Demonstrated technical expertise in chemical process development and new product introduction

• Demonstrated technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design to support process development objectives

• Demonstrated troubleshooting and problem solving skills.

• Experience of CMC regulatory requirements for pharmaceutical products

• Demonstrated track record of training and coaching colleagues to improve overall team process knowledge.

• Demonstrated track record of delivering positive results on a consistent basis.

• Proven project management skills for technical programs

• Experience in managing and maintaining budgets desirable

• Experience in defending processes, procedures and investigation during FDA/EMA (and other competent authorities) inspections desirable.

• Capability of grasping complex technical issues and make sound decisions based on data and information from various sources

• Knowledge of formulation development and/or large molecule technologies would be advantageous

• Excellent written and verbal communication skills.

Required/Preferred Education and Licenses

Bachelor’s degree and PhD in Chemistry

Description of Physical Demands

• Occasional mobility within office environment.

• Routinely sitting for extended periods of time.

• Constantly operating a computer, printer, telephone and other similar office machinery