Director, Pharmaceutical Development

📋 Description

• Provide scientific, technical, and strategic direction to the design, development, and manufacture
• Manage activities and contractual relationship with contract manufacturers and laboratories
• Lead and collaborate with cross functional project team members to meet CMC goals.
• Represent CMC DP and provide strategic recommendations and status reporting to cross-functional
• Author, review, and/or approve development reports, regulatory submissions (e.g., IND, IMPD, NDA
• Act as Subject Matter Expert for knowledge of GMP regulations, ICH guidance, and current regulatory

🎯 Requirements

• Advanced degree in Pharmaceutics, Chemistry or related field is highly preferred, equivalent work
• 10 to 12+ years of progressive experience in the Biotech or Pharmaceutical industry focused on
• Experience managing relationships with contract manufacturing organizations including knowledge of
• Familiarity with ICH guidelines and regulatory expectations relevant to drug development and cGMPs
• A strong track record of scientific achievement.
• Demonstrated ability to influence without direct control.

🎁 Benefits

• Paid Time Off, Holiday, and Sick Leave
• Medical, Dental and Vision Plans
• Short- and Long-Term Disability
• Basic and Voluntary Life/AD&D Coverage
• Flexible Spending Accounts (FSA, HSA, and Commute)
• Critical Illness and Accident Coverage