Associate Director, Drug Substance Development (Home Based / Remote) 12 Month FTC
Jazz Pharmaceuticals
9 hours ago
Remote
United States
Operations
Brief Description
Reporting to the Senior Director, Drug Substance Development, provide scientific and technical leadership for drug substance development projects across the development life cycle, including process design/development and translation into commercially feasible, reliable, robust processes. Work primarily with external CDMOs; lead/collaborate with cross-functional teams (Quality, CMC Regulatory, Manufacturing, New Product & Technology Integration) to support agile new product introduction and ensure processes are understood, robust, efficient, and in control. Project and operations oriented; manage multiple projects concurrently.
Essential Functions/Responsibilities
- Lead process development and cGMP manufacture of small-molecule drug substances at CDMOs.
- Ensure adequate drug substance supply for clinical studies and other needs.
- Oversee robust, reliable manufacturing process development using Quality by Design (QbD).
- Oversee synthesis of chemical entities for clinical and non-clinical studies.
- Ensure DS processes align with applicable regulations, policies, guidelines, and procedures.
- Represent the drug substance team on cross-functional project teams.
- Collaborate with CMC project team members to deliver project goals; contribute to continuous improvement; author/review drug substance sections of regulatory dossiers and technical reports.
- Support technology/product transfers to manufacturing sites.
- Communicate results to technical and non-technical audiences (written and verbal).
- Plan, budget, execute, and report on assigned projects.
- Develop knowledge of new manufacturing processes/technologies and share best practices.
Required Knowledge, Skills, and Abilities
- Strong achievement record in drug substance development and manufacturing.
- 10+ years’ experience, including drug substance chemical process development.
- Technical expertise in chemical process development and new product introduction.
- Scientific creativity; independent thought; experimental design to support process development.
- Troubleshooting and problem-solving skills.
- CMC regulatory requirements experience.
- Track record training/coaching colleagues.
- Proven consistent delivery of positive results.
- Project management skills for technical programs.
- Budget management experience (desirable).
- Experience defending processes/procedures/investigations during FDA/EMA inspections (desirable).
- Ability to grasp complex technical issues and make data-based decisions.
- Formulation development and/or large molecule technologies knowledge (advantageous).
- Excellent written and verbal communication.
Required/Preferred Education and Licenses
- Bachelor’s degree and Masters or PhD in Chemistry.
Benefits
- Medical, dental, and vision insurance; retirement savings plan; flexible paid vacation.
Application Instructions
- If a current Jazz employee, apply via the Internal Career site.
Reporting to the Senior Director, Drug Substance Development, provide scientific and technical leadership for drug substance development projects across the development life cycle, including process design/development and translation into commercially feasible, reliable, robust processes. Work primarily with external CDMOs; lead/collaborate with cross-functional teams (Quality, CMC Regulatory, Manufacturing, New Product & Technology Integration) to support agile new product introduction and ensure processes are understood, robust, efficient, and in control. Project and operations oriented; manage multiple projects concurrently.
Essential Functions/Responsibilities
- Lead process development and cGMP manufacture of small-molecule drug substances at CDMOs.
- Ensure adequate drug substance supply for clinical studies and other needs.
- Oversee robust, reliable manufacturing process development using Quality by Design (QbD).
- Oversee synthesis of chemical entities for clinical and non-clinical studies.
- Ensure DS processes align with applicable regulations, policies, guidelines, and procedures.
- Represent the drug substance team on cross-functional project teams.
- Collaborate with CMC project team members to deliver project goals; contribute to continuous improvement; author/review drug substance sections of regulatory dossiers and technical reports.
- Support technology/product transfers to manufacturing sites.
- Communicate results to technical and non-technical audiences (written and verbal).
- Plan, budget, execute, and report on assigned projects.
- Develop knowledge of new manufacturing processes/technologies and share best practices.
Required Knowledge, Skills, and Abilities
- Strong achievement record in drug substance development and manufacturing.
- 10+ years’ experience, including drug substance chemical process development.
- Technical expertise in chemical process development and new product introduction.
- Scientific creativity; independent thought; experimental design to support process development.
- Troubleshooting and problem-solving skills.
- CMC regulatory requirements experience.
- Track record training/coaching colleagues.
- Proven consistent delivery of positive results.
- Project management skills for technical programs.
- Budget management experience (desirable).
- Experience defending processes/procedures/investigations during FDA/EMA inspections (desirable).
- Ability to grasp complex technical issues and make data-based decisions.
- Formulation development and/or large molecule technologies knowledge (advantageous).
- Excellent written and verbal communication.
Required/Preferred Education and Licenses
- Bachelor’s degree and Masters or PhD in Chemistry.
Benefits
- Medical, dental, and vision insurance; retirement savings plan; flexible paid vacation.
Application Instructions
- If a current Jazz employee, apply via the Internal Career site.