Manager, Sterile Manufacturing - Houston, United States - Empower Pharmacy

Empower Pharmacy
Empower Pharmacy
Verified Company
Houston, United States

3 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description

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.


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 productionmonitoring 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.
  • Thorou
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