Head of Injectable Drug Product Development

American Regent, Inc.; New Albany (OH); On-site; USD 180,000 - 240,000; Full time

Job summary

American Regent, Inc. seeks a Director of R&D Product Development to lead end-to-end injectable drug product development strategy, from ideation to launch. You will oversee cross-functional teams, ensure regulatory compliance, and drive portfolio differentiation through QbD and advanced drug delivery platforms.

The role requires a Ph.D. in Life Sciences with 10+ years in formulation/process development and 7+ years of leadership, along with exceptional technical writing and communication skills.

Qualifications

• Ph.D. in Life Sciences (Chemistry or Pharmaceutical Science concentration) required.
• Minimum of 10 years’ experience in formulation, analytical, and process development with complex molecules.
• 7+ years of demonstrated leadership experience managing a team.
• Deep understanding of the drug discovery lifecycle and global regulatory requirements.
• Exceptional technical writing and interpersonal skills; ability to influence at the executive level.
• Excellent oral and written communication skills.

Responsibilities

• Lead development and execution of comprehensive pharmaceutical development strategies.
• Oversee preparation, review, and approval of critical development documentation (CMC, PDRs).
• Apply QbD principles and risk-based methodologies to accelerate timelines.
• Serve as scientific authority in Portfolio Management Committee meetings for NDAs and related filings.
• Maintain knowledge of parenteral delivery technologies and IP strategy.
• Develop and execute long-term R&D strategies aligned with growth objectives.

Skills

Leadership

Strategic thinking

Executive communication

Technical writing

Education

Ph.D. in Life Sciences

Tools

Word

Excel

PowerPoint

Outlook

Job description

American Regent, Inc. seeks a Director of R&D Product Development to lead end-to-end injectable drug product development strategy, from ideation to launch. You will oversee cross-functional teams, ensure regulatory compliance, and drive portfolio differentiation through QbD and advanced drug delivery platforms.

The role requires a Ph.D. in Life Sciences with 10+ years in formulation/process development and 7+ years of leadership, along with exceptional technical writing and communication skills.