Responsibilities

• Develop and execute the Chemistry, Manufacturing & Controls (CMC) strategy for drug and combination product portfolios.
• Lead and manage the drug development process, ensuring compliance with regulatory requirements and quality standards.
• Collaborate with cross-functional teams to integrate drug formulation, analytical methods, and manufacturing processes with medical device components.
• Oversee the advancement of lead assets through the NDA regulatory pathway, ensuring timely submissions and approvals.
• Conduct thorough assessments of drug product and formulation development, manufacturing scale-up, and quality assurance.
• Interface with regulatory authorities regarding CMC submissions and inquiries for combination products.
• Mentor and guide junior staff in CMC operations and regulatory compliance.

Requirements

• PhD or Master's degree in Pharmaceutical Sciences, Chemistry, or related field.
• Minimum of 8 years of experience in CMC within the pharmaceutical or biotechnology industry.
• Proven track record of leading drug product development from preclinical to commercialization stages.
• Strong knowledge of regulatory requirements and guidelines for drug formulation and combination products.
• Demonstrated ability to coordinate and manage cross-functional teams effectively.
• Excellent problem-solving, communication, and leadership skills.
• Experience with analytical method development and validation is highly desirable.

Benefits

• Competitive salary and performance-based bonuses.
• Comprehensive health, dental, and vision insurance plans.
• 401(k) retirement plan with company match.
• Generous paid time off and holiday schedule.
• Flexible work hours and remote work options.
• Opportunities for professional development and continuing education.
• Be part of a pioneering company transforming healthcare with innovative solutions.