Associate Director, Drug Product Development (Home Based/Remote)
Jazz Pharmaceuticals
7 hours ago
Remote
United States
$157,600 - $236,400 USD yearly
Operations
Application:
- If you are a current Jazz employee, please apply via the Internal Career site.
Essential Functions:
- Lead the development of small molecule drug product formulations appropriate to development phase with sufficient stability/robustness for clinical and/or commercial manufacturing.
- Specify product and process requirements (manufacturing equipment/methods, performance criteria, materials, test protocols, analytical methodology, packaging for clinical/commercial) and develop robust pharmaceutical production processes.
- Direct projects and lead cross-functional teams to achieve project goals on time and within budget.
- Create intellectual property and ensure freedom to operate for new drug products.
- Identify and select suitable drug product development and commercial manufacturing vendors (CMOs).
- Direct technical projects (internally and at CDMOs), including detailed technical work plans and vendor performance management.
- Work cooperatively with, or lead, internal and external teams as required.
- Author CMC sections of regulatory dossiers to enable acceptance by global regulators.
- Support asset due diligence, new product introduction, and integrations.
- Apply current knowledge of cGMP and industry standards for process design and validation to manage vendors and contract development organizations.
Required Skills/Qualifications:
- >10 years’ experience in drug product development in the pharmaceutical industry; direct experience with formulation development, process development, technical transfer and/or process validation.
- Demonstrated technical proficiency, engineering, collaboration/independent thought, and strong teamwork skills.
- Troubleshooting/problem-solving skills using designed experiments and statistical process control.
- Development/authorship of CMC regulatory filings.
- Excellent written and verbal communication.
- Current knowledge of quality systems and FDA/EU regulations related to pharmaceutical development and validation.
- Proven project management skills.
- Flexibility to travel when required.
Preferred Skills/Qualifications:
- Broad exposure to multiple drug delivery technologies and knowledge of standard dosage forms.
- Experience in intellectual property development.
Education:
- Advanced degree in Chemistry, Pharm. Sci., Engineering, or related field, or equivalent combination of education and work experience required.
Benefits (if applicable):
- Medical, dental, and vision insurance; 401k retirement savings plan; flexible paid vacation.
- If you are a current Jazz employee, please apply via the Internal Career site.
Essential Functions:
- Lead the development of small molecule drug product formulations appropriate to development phase with sufficient stability/robustness for clinical and/or commercial manufacturing.
- Specify product and process requirements (manufacturing equipment/methods, performance criteria, materials, test protocols, analytical methodology, packaging for clinical/commercial) and develop robust pharmaceutical production processes.
- Direct projects and lead cross-functional teams to achieve project goals on time and within budget.
- Create intellectual property and ensure freedom to operate for new drug products.
- Identify and select suitable drug product development and commercial manufacturing vendors (CMOs).
- Direct technical projects (internally and at CDMOs), including detailed technical work plans and vendor performance management.
- Work cooperatively with, or lead, internal and external teams as required.
- Author CMC sections of regulatory dossiers to enable acceptance by global regulators.
- Support asset due diligence, new product introduction, and integrations.
- Apply current knowledge of cGMP and industry standards for process design and validation to manage vendors and contract development organizations.
Required Skills/Qualifications:
- >10 years’ experience in drug product development in the pharmaceutical industry; direct experience with formulation development, process development, technical transfer and/or process validation.
- Demonstrated technical proficiency, engineering, collaboration/independent thought, and strong teamwork skills.
- Troubleshooting/problem-solving skills using designed experiments and statistical process control.
- Development/authorship of CMC regulatory filings.
- Excellent written and verbal communication.
- Current knowledge of quality systems and FDA/EU regulations related to pharmaceutical development and validation.
- Proven project management skills.
- Flexibility to travel when required.
Preferred Skills/Qualifications:
- Broad exposure to multiple drug delivery technologies and knowledge of standard dosage forms.
- Experience in intellectual property development.
Education:
- Advanced degree in Chemistry, Pharm. Sci., Engineering, or related field, or equivalent combination of education and work experience required.
Benefits (if applicable):
- Medical, dental, and vision insurance; 401k retirement savings plan; flexible paid vacation.