Jazz Pharmaceuticals · 1 day ago
Associate Director, Drug Substance Development (Home Based / Remote) 12 Month FTC
United States
Contract
Remote
Lead/Staff, Director/Executive
10+ years expJazz Pharmaceuticals is a global biopharma company dedicated to developing life-changing medicines for serious diseases. The Associate Director of Drug Substance Development will provide scientific and technical leadership for drug substance development projects, ensuring robust processes and cross-functional collaboration while overseeing the development and manufacture of small molecule drug substances.
BiotechnologyHealthcarePharmaceuticalHealth Care
Responsibilities
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
Qualification
Required
Strong record of achievement in drug substance development and manufacturing
Over ten years of 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
Excellent written and verbal communication skills
Bachelor's degree and Masters or PhD in Chemistry
Preferred
Experience in managing and maintaining budgets desirable
Experience in defending processes, procedures, and investigation during FDA/EMA (and other competent authorities) inspections desirable
Knowledge of formulation development and/or large molecule technologies would be advantageous
Benefits
Medical, dental and vision insurance
Retirement savings plan
Flexible paid vacation
Company
Jazz Pharmaceuticals
Jazz Pharmaceuticals is a specialty pharmaceutical company that identifies, develops and commercializes innovative treatments.
1001-5000 employees
H1B Sponsorship
Jazz Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (26)
2024 (24)
2023 (25)
2022 (31)
2021 (21)
2020 (39)
Funding
Current Stage
Public CompanyTotal Funding
$2.81BKey Investors
Longitude CapitalKohlberg Kravis Roberts & Co.
2024-09-03Post Ipo Debt· $850M
2021-04-22Post Ipo Debt· $1.5B
2009-12-07Post Ipo Debt· $120M
Leadership Team
Renée Galá
President and Chief Executive Officer
Dennis Engelke
Executive Director, Country Manager Switzerland & Austria
Recent News
2026-02-08
Pharmaceutical Technology
2026-02-05
Company data provided by crunchbase