Vice President of Product Development

8 hours ago

Houston, Texas, United States Empower Pharmacy Full time
Empower Pharmacy: A Visionary Leader in Healthcare

Empower Pharmacy is a pioneering healthcare company dedicated to providing high-quality, affordable medication to millions of patients across the nation. As a visionary leader in the industry, we are committed to excellence in every aspect of our operations.

Job Summary

We are seeking an exceptional Vice President of Product Development to join our team. This is a pivotal role that requires a seasoned professional with a deep understanding of pharmaceutical development, regulatory compliance, and quality assurance. The successful candidate will be responsible for leading our product development strategy, ensuring compliance with regulatory standards, and maintaining high-quality production processes.

Key Responsibilities
  • Develop and implement a robust product development strategy that aligns with Empower Pharmacy's overarching ambition to redefine healthcare access.
  • Lead the development of sterile and non-sterile drug products, including tablets, capsules, creams, ointments, nasal sprays, and hair solutions, through the creation of Master Batch Records (MBRs).
  • Ensure compliance with regulatory standards and maintain high-quality production processes.
  • Implement best practices and innovative techniques to improve product efficacy and safety.
  • Develop and maintain a high-performing Analytical Method Development team to encompass 98%+ of the sterile drug product in Empower's formulary.
  • Ensure the team creates accurate, reliable analytical methods to support product development and quality control.
  • Foster a First-Time-Right concept of 98%+ to ensure methods transferred to Quality Control are accepted and effortlessly transferrable.
  • Develop and maintain product management teams that collaborate with internal and external stakeholders, who are the cradle-to-grave owners of product families, closely collaborating with all departments and industry changes.
  • Manage change based on market or regulatory criteria to ensure product relevance and compliance.
  • Responsible for change management for all product-related changes.
  • Build a team capable of successfully managing Investigation New Drugs for Biosimilars and Abbreviated New Drug Applications.
  • Responsible for building the product portfolio from concept through commercialization.
  • Works with Executive, Marketing, Sales, and Capital Development teams to ensure project timeliness and success.
  • Ensures all regulatory submissions are thorough, accurate, and timely.
  • Establishes a technical formulation team specializing in complex formula development.
  • Oversees lyophilization cycle development and optimization to enhance product stability and efficacy.
  • Provides technical leadership on new drug product introduction for 503A, 503B, Contract Development Manufacturing Organization business opportunities, and approved drug products (small molecule and large molecule).
  • Assists with current formulations as needed.
  • Responsible for the development of medical device design as needed.
  • Responsible for ensuring primary, secondary, and tertiary packaging is part of the new drug product design.
  • Responsible for the drafting and creation of raw material and finished product specifications.
  • Manages product portfolio mapping across multiple sites to ensure alignment with company strategy and market needs, while identifying opportunities for new product development and portfolio expansion.
  • Proactively assists with development prior to site transfer/adoption of the new drug product.
  • Provides strategic guidance on product development opportunities-focusing on product-specific, active pharmaceutical ingredient-specific, and category-specific areas for both current and long-term planning-while ensuring alignment with overall company goals.
  • Ensures products are commercially robust from inception of product development through tech transfer into the manufacturing facilities.
  • Fosters an environment for innovation through filing of patents, new drug applications, combination products, etc.
  • Manages proactive communication across all sites and up to the Chief Executive Officer through proper means of effective Project Management governance.
  • Manages teams effectively by creating and maintaining individual and group Key Performance Indicators.
  • Hires, trains, and manages workforce effectively to meet business needs.
  • Performs other duties as assigned.

Empower Pharmacy offers a comprehensive benefits package, including no-cost medication, onsite health and wellness services, comprehensive medical, dental, and vision options, and a rewards and recognition program. If you are a seasoned professional with a passion for pharmaceutical development and a commitment to excellence, we encourage you to apply for this exciting opportunity.

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