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Director, Research and Development

4 months ago

Orange, United States Empower Pharmacy 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

The Director of Research and Development (R&D) will lead Empower Pharmacy’s efforts in developing innovative pharmaceutical compounded products. In this role, you will receive and review new product requests from

practitioners and

will develop the plan and strategy from the

initial

conceptual request through manufacturing .

Duties and Responsibilities

Provides

strategic and technical leadership in the development dosage forms supported by Empower. Serves as an influencer for the direction of company’s product line. Serves as a technical expert for all

formulation ,

product

development

and analytical method development

opportunities. Guide the team to develop formulations by following

DoE and

QbD

principles. Executes development for both new products added to the daily queue and for new product lines that are more strategic and long-term in development. Manages and conducts research and development studies

utilizing

both internal and external resources. Serves and/or leads the continuous improvement and formulation development teams. Researches, investigates, develops,

improves,

and scales compounding practices. Coordinates closely with sales as a business development liaison to understand clients’ and/or industry requirements for specific products or product lines. Coordinates closely with manufacturing leadership (compounding, quality , technical

services

and engineering) to ensure development activities align with established company systems and long-term commercial scale manufacturing requirements. Oversees the recipe management system (Master Formulation Record) to ensure all recipes are detailed, updated and executable. Designs,

conducts

and documents stability testing protocols to recommend and support product

dating. Resolves production formulation issues and

provides

on-the-floor oversight as

needed. Manages drug applications as needed. 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 essential functions. While performing the responsibilities of the job, the employee

is required to

talk and

hear . The employee

is often required to 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 must stand for most of the shift (5 days/8 hours) and move about the office and around the corporate campus. The employee

is required to

stand, walk, reach with arms and hands, climb or balance, stoop, kneel, crouch, or crawl. Vision abilities required by this job include close vision, also the ability to lift 40 lbs. objects from the floor is

required . The employee must

utilize

proper PPE, including but not limited to scrubs, bouffant cap, beard cover, shoe covers, gloves, N-95 mask, safety glasses, lab gown, full-body coverall,

full-face and/or half-face respirators while performing their daily tasks in Non-Sterile Hazardous and Non-Hazardous Lab controlled environments.

Knowledge and Skills

Expertise

in USP,

cGMPs ,

ICH and

FDA guidelines. Excellent communication skills for external facing customers. Strategic view as well as hands-on problem-solving skills. Ability to work independently to manage work tasks effectively. Must be detail oriented and

possess high

level of accuracy. Ability to adapt to changing responsibilities while coordinating multiple job tasks. Ability to prioritize work and meet deadlines. Must be self-starter and

results driven. Must

possess

problem solving and analytical skills. Sensitivity to confidential documents and information. Must be able to enter the production environment as needed (non-sterile lab and cleanroom). 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

Advanced degree in Pharmaceutics, Pharmacy, or related field. 10+ years related formulations experience. Previous

successful management experience is

required. Lean Six Sigma Manufacturing Green Belt Certification 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. Advanced degree in Pharmaceutics, Pharmacy, or related field. 10+ years related formulations experience. Previous

successful management experience is

required. Lean Six Sigma Manufacturing Green Belt Certification is preferred. Expertise

in USP,

cGMPs ,

ICH and

FDA guidelines. Excellent communication skills for external facing customers. Strategic view as well as hands-on problem-solving skills. Ability to work independently to manage work tasks effectively. Must be detail oriented and

possess high

level of accuracy. Ability to adapt to changing responsibilities while coordinating multiple job tasks. Ability to prioritize work and meet deadlines. Must be self-starter and

results driven. Must

possess

problem solving and analytical skills. Sensitivity to confidential documents and information. Must be able to enter the production environment as needed (non-sterile lab and cleanroom). 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.

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