Essential Duties & Responsibilities:

• Responsible for formulation and process development of sterile injectable drug products, including lyophilization cycle development, following Quality by Design (QbD) principles
• Design/conduct development studies, accurately interpret the outcome of the studies and propose appropriate follow-up studies with minimal guidance, applying scientific and regulatory knowledge
• Propose/define drug product manufacturing processes and control strategies based on results from development studies and available literature information
• Represent the Formulation group in cross-departmental project teams
• Communicate own work effectively orally and in writing
• Prepare technical protocols and reports
• Report and treat data with a high level of integrity and ethics
• Contribute to the drafting of documents for regulatory filings and responses to deficiencies
• Partner with CMOs to ensure transfer of manufacturing process to support a timely FDA filing
• Support responses to comments from the FDA
• Provide technical feedback to request proposals from CMOs and provide proposal comments
• Develop project schedules for projects
• Work within a cross-functional environment
• Adjust work hours as needed to meet with global partners
• Support due diligence activities
• Some travel domestically/internationally may be required
• Other duties as assigned

Qualifications:

• Ability to work in a diverse and dynamic work environment
• Ability to manage a formulation project without oversight
• Demonstrated knowledge of pharmaceutical formulation and process development
• Demonstrated leadership experience overseeing scientists in development activities
• Strong experience in formulation development
• Excellent written and verbal communication skills
• Excellent investigative and implementation skills
• Excellent time management and organizational skills
• Strong team player with a can-do attitude

Education & Experience:

• BA/BS/MA/MS or PhD degree in pharmaceutical sciences or closely related field; Advanced degree (PhD) is preferred
• Five (5) – 10+ years of experience in the parenteral pharmaceutical industry
• Expertise and hands-on experience in parenteral (sterile injectable or ophthalmic) product and process development
• Experience in generic product development is preferred