Director Formulation (Solid-Orals)

Summary

This industry leading "people-first" pharmaceutical company is seeking a Director of Formulation Development to spearhead efforts in creating groundbreaking medications & managing their portfolio of solid-oral drug products. This role involves guiding a team in the development of small molecule projects, ensuring both technical excellence and adherence to regulatory standards. Join us in revolutionizing pharmaceutical therapies and making high-quality, affordable medication accessible to all.

Key Responsibilities

• Lead the development of pharmaceutical formulations for various types of products, providing strategic direction and expertise to ensure projects progress efficiently from research to manufacturing.
• Oversee the design, development, and optimization of non-sterile formulations, ensuring compliance with industry regulations and standards.
• Manage the transfer of products to production facilities across the country, coordinating with third-party vendors and external labs for additional support.
• Work closely with quality and regulatory teams to ensure all formulations meet regulatory requirements, maintaining thorough documentation and validation protocols.
• Drive innovation in formulation techniques, utilizing advanced technologies to improve product efficacy, safety, and scalability. Mentor and manage a high-performing team dedicated to continuous improvement.
• Exhibit strong leadership, communication, and organizational skills, effectively collaborating with cross-functional teams and navigating complex regulatory environments.
• Demonstrate expertise in formulation design, process validation, and aseptic techniques, with a deep understanding of regulatory guidelines and standards. Utilize data-driven methods for problem-solving and process optimization.

Qualifications

• Ph.D. (preferred) or Master's degree in Pharmaceutical Sciences, Chemistry, or a related field with at least 10 years of experience in pharmaceutical formulation development.
• 3 years (Minimum) experience managing direct reports.
• Experience with solid orals (tablets, capsules, etc.) is a MUST.
• Excellent problem-solving abilities and a proactive approach to overcoming challenges.
• Must have experience with product launches (NDA/505(b)(2), ANDA, OTC products are highly desired)
• Experience with project management tools and methodologies.
• Ability to work effectively in a fast-paced, dynamic environment.
• Strong interpersonal skills and the ability to build and maintain relationships with internal and external stakeholders.

Benefits

• Offers a strong & comprehensive benefits package to support your health and well-being, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, and more.