Director, Drug Product Development (Home Based / Remote)
If you are a current Jazz employee please apply via the Internal Career site.
Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life‑changing medicines for people with serious diseases — often with limited or no therapeutic options. Our portfolio includes leading therapies for sleep disorders, epilepsy, and a growing range of cancer treatments. Jazz is headquartered in Dublin, Ireland, with research and development laboratories, manufacturing facilities, and employees worldwide.
The Director of Drug Product Development is responsible for scientific and technical leadership of Pharmaceutical Development programs at various stages of the development life‑cycle, including preformulation, formulation, process development, technical transfer, and validation. The Director will oversee drug product aspects from preformulation to clinical trial supply and technology transfer/commercialization, and lead cross‑functional CMC development teams.
Essential Functions
Lead development of small‑molecule drug product formulations, ensuring stability and robustness for clinical and commercial manufacturing.
Specify product and process requirements, including equipment, methods, performance criteria, materials, test protocols, analytical methodology, and packaging.
Direct projects and lead cross‑functional teams with technical proficiency and scientific creativity to meet goals on time and within budget.
Create intellectual property covering Jazz products to ensure freedom to operate.
Support selection of suitable drug product development and commercial manufacturing vendors (CMOs).
Direct technical projects at CDMOs, developing detailed work plans and managing vendor performance.
Author CMC sections of regulatory dossiers for products at all stages.
Enhance ways of working in Drug Product development using industry best practices.
Required Knowledge, Skills, and Abilities
10–15 years of experience in drug product development, including formulation, process development, technical transfer, and/or validation.
Demonstrated technical proficiency and independent thought.
Strong track record of impactful Pharmaceutical Development projects.
Ability to lead cross‑functional CMC teams and troubleshoot using designed experiments.
Experience with CMC regulatory filings and inspections.
Broad exposure to multiple drug delivery technologies and standard dosage forms.
Excellent written and verbal communication, including executive‑level communication.
Knowledge of quality systems and FDA/EU regulations related to development and validation.
Proven project management skills for technical programs.
Flexibility to travel when required.
Required/Preferred Education and Licenses
Master’s degree, PhD, or equivalent combination of education and experience.
Description of Physical Demands
Occasional mobility within office environment; routinely sitting for extended periods.
Constant computer, printer, telephone, and office machinery operation.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
Associate Director, Drug Product Development (Home Based/Remote)
If you are a current Jazz employee please apply via the Internal Career site.
The Associate Director provides scientific and technical leadership for Pharmaceutical Development programs, overseeing drug product aspects from preformulation to commercialization and may lead cross‑functional CMC teams.
Essential Functions
Lead development of small‑molecule drug product formulations with sufficient stability and robustness.
Specify product and process requirements, including equipment, methods, criteria, materials, test protocols, analytical methodology, and packaging.
Direct projects and lead cross‑functional teams, ensuring project goals are met on time and within budget.
Create intellectual property to secure freedom to operate.
Support selection of suitable drug product development and manufacturing vendors (CMOs).
Direct technical projects internally and at CDMOs, including creating detailed work plans and managing vendor performance.
Author CMC sections of regulatory dossiers for all product stages.
Support asset due diligence, new product introduction, and integrations.
Required Knowledge, Skills, and Abilities
10+ years of experience in drug product development, including formulation, process development, technical transfer, and validation.
Demonstrated technical proficiency and teamwork skills.
Strong problem‑solving skills using designed experiments and statistical process control.
Experience with CMC regulatory filings and inspections.
Broad exposure to drug delivery technologies and dosage forms.
Excellent written and verbal communication.
Knowledge of quality systems and FDA/EU regulations.
Proven project management for technical programs.
Flexibility to travel when required.
Required/Preferred Education and Licenses
Advanced degree in Chemistry, Pharm. Sci., Engineering, or related field.
Description of Physical Demands
Occasional mobility within office environment; routinely sitting for extended periods.
Constant computer, printer, telephone, and office machinery operation.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
Associate Director, Drug Substance Development (Home Based / Remote) 12 Month FTC
If you are a current Jazz employee please apply via the Internal Career site.
The Associate Director provides scientific and technical leadership for drug substance development projects, ensuring robust, commercially feasible, and reliable processes and coordinating with external CDMOs.
Essential Functions/Responsibilities
Lead process development and cGMP manufacture of small‑molecule drug substances at CDMOs.
Ensure adequate supply for clinical studies and other needs.
Oversee development of robust and reliable manufacturing processes using QbD principles.
Oversee synthesis of chemical entities to support studies.
Ensure all drug‑substance processes comply with applicable regulations and policies.
Represent the drug‑substance team on cross‑functional project teams.
Work closely with CMC project team members to meet project goals, contribute to continuous improvement, and author/review regulatory dossiers.
Support technical operations to ensure smooth transfer of technologies and products.
Communicate ideas and results to technical and non‑technical audiences.
Plan, budget, execute, and report on assigned projects.
Develop knowledge of new pharmaceutical manufacturing processes and share best practices.
Required Knowledge, Skills, and Abilities
Strong record of achievement in drug substance development and manufacturing.
Over ten years of experience across drug development and manufacturing technologies, with specific focus on drug‑substance chemical process development.
Demonstrated technical expertise in chemical process development and new product introduction.
Independent experimental design and troubleshooting skills.
Experience with CMC regulatory requirements.
Track record of training and coaching colleagues.
Consistent delivery of positive results.
Proven project management skills for technical programs.
Experience managing and maintaining budgets.
Experience defending processes during FDA/EMA inspections.
Ability to make data‑driven decisions on complex technical issues.
Knowledge of formulation development and/or large molecule technologies is advantageous.
Excellent written and verbal communication.
Required/Preferred Education and Licenses
Bachelor’s degree and Masters or PhD in Chemistry.
Description of Physical Demands
Occasional mobility within office environment; routinely sitting for extended periods.
Constant computer, printer, telephone, and office machinery operation.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
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