Director of Formulation (Solid Oral)

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Summary
Before applying for this role, please read the following information about this opportunity found below. 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--Topicals a PLUS 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.
Location:
Houston, TX
Category:
Manufacturing And Production

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