Assoc Dir, Drug Product Development

Responsibilities

• Lead development of small molecule drug product formulations
• Specify product and process requirements for manufacturing
• Direct projects and lead cross-functional teams effectively
• Create intellectual property for the company's products
• Support selection of suitable CMOs for product development
• Manage technical projects and vendor performance
• Author CMC sections of regulatory dossiers for global acceptance

Qualifications

• 10+ years of experience in drug product development in the pharmaceutical industry
• Proficiency in formulation development and process validation
• Strong problem-solving skills with experience in designed experiments
• Experience authoring CMC regulatory filings for pharmaceutical products
• Broad exposure to various drug delivery technologies
• Excellent verbal and written communication skills
• Current knowledge of FDA and EU regulations regarding pharmaceutical development

Pay

• $157,600 – $236,400 annually

Schedule

• Remote - US based candidates only, no visa sponsorship available

Benefits

• Medical, dental, and vision insurance
• 401k retirement savings plan
• Flexible paid vacation
• Discretionary annual cash bonus eligibility
• Discretionary equity grants based on performance

Our client is an equal opportunity employer.