Vice President, Product Development 503A - Houston, TX

Houston, Texas


Employer: Empower Pharmacy
Industry: Manufacturing
Salary: Competitive
Job type: Full-Time

Company Overview

Empower is a visionary healthcare company committed to providing quality, affordable medication to millions of patients across the nation. We hold the distinguished position of being the largest 503A compounding pharmacy and FDA-registered 503B outsourcing facility in the country serving the functional medicine markets.

What sets us apart is our relentless focus on three core values: People, Quality and Service. Our dedicated team of professionals collaboratively works to break new ground in the fields of manufacturing, distribution and quality control, providing a uniquely integrated approach to healthcare. Leveraging our vertical integration of the pharmaceutical supply chain, state-of-the-art technology, and a commitment to excellence, we are constantly pushing the boundaries of what is possible in medication accessibility and affordability.

You're not just starting a job; you're joining a mission. We believe in empowering our team to innovate, grow, and drive real change in the healthcare industry. If you're a forward-thinker who thrives in a fast-paced, transformative environment, Empower is the place for you. Here, you'll be encouraged to share your ideas, expand your skill set, and contribute to projects that genuinely make a difference. We prioritize the well-being of our team members, and we offer a supportive and engaging workplace where your contributions are not just recognized but celebrated.

Let's revolutionize healthcare, together. Join us and be a part of something extraordinary.

Position Summary

In your role as Vice President of Product Development at Empower, you will be at the forefront of a transformative journey, steering our operations with visionary leadership and unwavering commitment to excellence. This pivotal position is not just about product development; it's about being a catalyst for innovation, setting new benchmarks in patient safety, and ensuring our products surpass the stringent demands of regulatory compliance while managing complexity.

Your mission is to sculpt a product development strategy that is not only robust but also resonant with Empower's overarching ambition to redefine healthcare access. Your leadership will be the cornerstone in ensuring that our operations are a beacon of quality, safety, and efficiency. You will be the architect of our product portfolio, shaping processes that ensure our products are not only compliant but also embody the pinnacle of pharmaceutical excellence through commercialization.

With your deep product development acumen, you will be creating new products across all facilities from compounded to approved drug products, performing with speed but without compromise to quality. Your decisions will have a profound impact across the organization, underscoring the vital role you play in our mission to enhance patient health and well-being.

This is more than a role; it's a calling to drive change, champion innovation, and lead with integrity. Your stewardship will fortify Empower's standing as a trailblazer in healthcare, ensuring we continue to deliver on our promise of expanding access to quality, affordable medication.

Duties and Responsibilities

  • Ensures compliance with regulatory standards and maintains high-quality production processes.
  • Leads the development of sterile drug products, including sterile pellets, injectables and lyophilized drug products through the creation of Master Batch Records (MBRs).
  • Leads the development of non-sterile drug products, including tablets, capsules, creams, ointments, nasal sprays, and hair solutions, etc. through the creation of MBRs.
  • Ensures compliance with regulatory standards and maintains high-quality production processes.
  • Implements best practices and innovative techniques to improve product efficacy and safety.
  • Develops and maintains a high-performing Analytical Method Development team to encompass 98%+ of the sterile drug product in Empower's formulary.
  • Ensures the team creates accurate, reliable analytical methods to support product development and quality control.
  • Fosters a First-Time-Right concept of 98%+ to ensure methods transferred to Quality Control are accepted and effortlessly transferrable.
  • Develops and maintains 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.
  • Manages change based on market or regulatory criteria to ensure product relevance and compliance.
  • Responsible for change management for all product related changes.
  • Builds 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.


To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions.

While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is occasionally required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. Vision abilities required by this job include close vision.

Knowledge and Skills

Key Competencies
  • Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
  • Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
  • Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
  • Resourcefulness: Secures and deploys resources effectively and efficiently.
  • Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems.
  • Ensures Accountability: Holds self and others accountable to meet commitments and objectives.
  • Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.
  • Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.

Experience and Qualifications

  • Bachelor's of Science in a scientific field. A Master's degree and/or Doctor of Philosophy in a relevant technical field preferred.
  • 25 + years of relevant experience in a regulated industry (preferably Food and Drug Administration (FDA)-regulated biotech/pharmaceutical).
  • Minimum of 10 years of experience managing teams in a current Good Manufacturing Practice environment required for the FDA regulated sites.
  • Previous experience as ‘Head of Formulations' or equivalent responsibility from a technical capability.
  • Previous experience developing Biosimilars or filing a Biologics License Application required.
  • Previous experience in sterile and non-sterile drug product development is required.
  • Experience in the pertaining areas of regulatory jurisdiction for the governing site required.
  • Previous experience with peptide development is preferred.

Employee Benefits, Health, and Wellness

  • No-Cost Medication: Get your prescribed compounded medications at no cost, ensuring your health without the financial burden.
  • Onsite Health & Wellness - IV Therapy Drips: Rejuvenate with complimentary onsite IV Therapy drips, enhancing your well-being and energy levels.
  • Comprehensive Medical, Dental, and Vision Options: Choose from three medical plans tailored to your needs, plus options for dental and vision coverage for you and your family.
  • Telehealth visits: Access board-certified Doctors anytime, anywhere for you and your family.
  • Paid & Volunteer Time Off: Enjoy paid time off for personal pursuits and contribute to causes you care about with volunteer time off.
  • Paid Holidays (8 scheduled; 2 floating): Celebrate with eight scheduled holidays and two floating holidays, giving you flexibility and time for personal traditions.
  • Life & AD&D Coverage: Secure your and your family's financial future with life and accidental death and dismemberment (AD&D) insurance.
  • FSA (Flexible Spending Account): Manage healthcare expenses smartly with pre-tax dollars in a Flexible Spending Account (FSA).
  • 401K Dollar-for-Dollar Up to 4%: Invest in your future with our 401K plan, featuring a dollar-for-dollar match up to 4%.
  • Company Paid Long-Term Disability: Provided at no cost, which replaces 60% of your income if you become disabled for a long period of time.
  • Flexible Schedules: Balance work and life seamlessly with our flexible scheduling options.
  • Rewards & Recognition Program: Your hard work doesn't go unnoticed - enjoy rewards and recognition beyond your paycheck.


Additional Voluntary Benefits
  • Accident Insurance: Pays a lump sum benefit to help cover expenses following an accidental injury.
  • Hospital Indemnity Insurance: Enhance your peace of mind with supplemental hospital insurance for unexpected stays.
  • Critical Illness: Protect your finances from the expenses of a serious health issue.
  • Short-Term Disability: Protect your income during illness or injury with short-term disability coverage.
  • Supplemental Life & AD&D: Add an extra layer of financial protection for you and your loved ones with supplemental life and AD&D coverage.
  • Legal Services: Access professional legal assistance to address concerns confidently.
  • Identity Theft Protection: Safeguard your identity and finances with our identity theft protection benefit.
  • Pet Insurance: Care for your furry family members with our pet insurance coverage.
  • Employee Assistance Program: Confidential counseling and support services for a holistic approach to your well-being.

Created: 2024-09-26
Reference: 2682
Country: United States
State: Texas
City: Houston
ZIP: 77069


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