What are the responsibilities and job description for the Coordinator, Research and Development position at Empower Pharmacy?
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
Step into the role of Research and Development Coordinator at Empower, where you will be pivotal in driving the advancement of healthcare through innovative research and product development. This critical position is integral in maintaining the integrity and progress of our research initiatives, aligning with our values of people, quality, service, and innovation.
In this essential role, you will support the organization and monitoring of product development and stability studies for new pharmaceutical products. Your responsibilities will include maintaining precise product development protocols, stability schedules, and comprehensive reports. Through meticulous documentation and steadfast adherence to data integrity and regulatory compliance, you will ensure the reliability and accuracy of all research outputs thereby upholding our high standards of data integrity and regulatory compliance.
Your day-to-day activities will also involve collecting, analyzing, and interpreting stability data to identify trends and deviations, thus ensuring the reliability of our research outcomes. You will coordinate with third-party analytical testing labs to manage sample submissions and procure quotes, maintaining efficiency and timeliness in all transactions. This role requires a collaborative spirit as you work closely with the Research and Development, Manufacturing, and Quality departments to provide essential stability data and support for both new product development and post-approval changes.
Joining Empower as a Research and Development Coordinator is an opportunity to immerse yourself in a role that challenges and leverages your analytical expertise in a meaningful way. You will have opportunities to contribute to our commitment to innovation and excellence in pharmaceutical research. Here, your work will directly impact our ongoing efforts to provide high-quality, innovative medications that support healthier, happier lives.
Duties and Responsibilities
- Supports the Research and Development department by coordinating and monitoring the product development and stability studies of new products and associated projects.
- Assists in developing and maintaining product development, stability protocols, schedules, reports, and documentation for all studies.
- Works proactively with other cross-functional groups to execute change controls associated with Manufacturing Standard Operating Procedures (SOP’s), protocols, and reports.
- Assists with ensuring the flow of information and documentation during the tech transfer process.
- Collects, analyzes, and interprets stability data, including trends and deviations.
- Coordinates with 3rd party analytical testing labs for sample submissions, quote procurement, and other related tasks in a timely manner.
- Maintains accurate and comprehensive records for all product development activities, ensuring data integrity and traceability.
- Analyzes and interprets lab testing results within the Research and Development and production life cycle.
- Generates and maintains stability reports, including recommendations for product shelf-life and storage conditions.
- Collaborates between Research and Development, Manufacturing, and Quality departments to provide stability data, and support for new product development and post-approval changes.
- Assists with investigating new and existing product deviations.
- 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 remain in a stationary position for a significant amount of the work day and frequently use their hands and fingers to handle or feel in order 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. Employees will regularly be exposed to areas in which moving mechanical parts, fumes, toxic chemicals are present. The noise level is the office environment is typically quiet, but the employee may occasionally be exposed to loud noises. The noise level for this position will vary and the employee may be exposed to loud noise levels. Employees may occasionally be required to lift up to 25 lbs. Vision abilities required by this job include close vision.
Knowledge and Skills
- Working knowledge of 21 CFR Part 210 & 211, USP <795>, <797>, and <800> compliance required.
- Strong understanding of stability testing principles and regulatory requirements (ICH guidelines, FDA regulations).
- Working knowledge of industry, regulatory, and compliance guidelines (PDA, ICH, etc.).
- Working knowledge of non-sterile and sterile product formulation.
- Working knowledge of laboratory methods, aseptic/cleanroom practices, and technical documentation.
- Excellent attention to detail.
- Proficient in Microsoft Office Skills-Excel, Word, PowerPoint, Outlook.
- Ability to provide accurate and efficient customer service under pressure of constant deadlines.
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 other accountable to meet commitment.
- 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
- Associates degree in a scientific field required, Bachelor's degree preferred.
- 5 years of previous relative pharmaceutical industry experience required.
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.