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Manager, Sterile Manufacturing
Empower Pharmacy Houston, TX
$112k-143k (estimate)
Full Time | Ancillary Healthcare 1 Month Ago
Save

Empower Pharmacy is Hiring a Manager, Sterile Manufacturing Near Houston, TX

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

At Empower, we are on a mission to help people live healthier, happier lives through innovative, affordable medications. As a Manager, Sterile Manufacturing, you will be a key player in this mission. You will be at the forefront of our sterile manufacturing operations, leading a team dedicated to excellence and innovation. Your role will be critical in guaranteeing strict adherence to current Good Manufacturing Practices (cGMP), USP 797/800, Code of Federal Regulation (CFR), and department Standard Operating Procedures (SOP) ensuring that our high standards for quality and safety are met consistently,

As the Manager of Sterile Manufacturing, you will play a vital role in overseeing and directing the daily operations of our sterile manufacturing team, ensuring that our injectable value stream is managed seamlessly from supply to release. Your leadership will help maintain compliance with regulatory standards, all while driving continuous improvement.

Collaboration is key, and you will interact with various departments, including QA/QC, Facilities & Engineering, Supply Chain, and Operations, to ensure that production issues are promptly resolved with quality in mind. Your leadership and contributions will also be key in identifying opportunities for efficiency improvements and capital investments.

If you thrive in a fast-paced environment, are passionate about innovation and ready to take on a challenging and rewarding role where you can make a real difference, we invite you to apply today and join our team. Your leadership and expertise will be valued and celebrated as we work together to provide healthcare solutions and expand access to quality, affordable medication.

Duties and Responsibilities
  • Manages assigned manufacturing operations which might include processing source materials, equipment and component preparation and sterilization, aseptic filtration, aseptic filling, aseptic cleaning.
  • Uses sound judgment and effective decision making to lead day to day operations of the group.
  • Applies sound technical and management principles to drive manufacturing execution and department performance within defined timelines.
  • Manages injectable value stream from beginning to end (supply/scheduling to release).
  • Reviews and updates manufacturing documentation associated with the manufacturing areas.
  • Responsible for production schedule.
  • Coordinates and provides cGMP, job tasks, and safety training for personnel in the manufacturing areas.
  • Maintains compliance with regulatory functions (FDA and/or USP).
  • Actively contributes to the resolution of manufacturing equipment and process issues.
  • Performs deviation investigations related to assigned areas of responsibility along with implementing corrective actions to prevent the recurrence of such deviations.
  • Initiates continuous process improvements.
  • Monitors and coordinates inventory with Supply Chain.
  • Prepares production-monitoring reports and participates in analysis of product cost and budgeting process.
  • Analyzes and makes recommendations regarding capital expenditure and efficiency improvements in the manufacturing areas.
  • Interacts with all supporting departments (ex: QA/QC, Facilities & Engineering, Supply Chain, Operations, etc...) to ensure production problems are dealt with promptly and with appropriate quality considerations.
  • Assists with the validation of processes and equipment.
  • Ensures that all environmental monitoring limits are maintained in all areas.
  • Revises, creates and ensures compliance with SOP regarding process changes, regulatory guidelines, or as needed.
  • Generates, updates, and maintains area SOP.
  • Partners with department leadership to evaluate headcount needs of department and participate in recruitment efforts.
  • Mentors and coaches direct reports, providing guidance, support, and feedback to foster their professional growth and development.
  • Fosters a culture of collaboration and resourcefulness, inspiring excellence.
  • Evaluates performance and completes annual performance reviews for direct reports.
  • Maintains hourly employee work schedules, monitors attendance, and monitors performance.
  • 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. Ability to lift up to 30 lbs.

Knowledge and Skills
  • Understanding of standard concepts, practices, and procedures within the aseptic pharmaceutical field.
  • Thorough knowledge and understanding of equipment such as autoclave and parts washer, depyrogenation oven, peristaltic pumps and laminar airflow workbenches/BSCs.
  • Must be able to work in an aseptic area. Must be able to pass gowning tests and procedures and media fill tests to be a qualified cleanroom operator. Required to gown into the cleanroom daily.
  • Knowledge of Microsoft Office 365. 

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 commitment.
  • Situational Adaptability: Adapts approach and demeanor in real time to match the 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 of Science in Life Sciences or closely related discipline required.
  • 5 years of management/supervisory experience in an aseptic production environment is required.
  • Strong cGMP, aseptic processing, and USP 797/800 background required.
  • Strong understanding of FDA regulations and CFR, including experience with regulatory inspections
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.

Job Summary

JOB TYPE

Full Time

INDUSTRY

Ancillary Healthcare

SALARY

$112k-143k (estimate)

POST DATE

05/19/2024

EXPIRATION DATE

05/09/2025

WEBSITE

empowerpharmacy.com

HEADQUARTERS

JERSEY VILLAGE, TX

SIZE

200 - 500

FOUNDED

2009

CEO

SHAUN NOORIAN

REVENUE

$10M - $50M

INDUSTRY

Ancillary Healthcare

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