Manager, Fill Finish Technical Operations Position Available In Palm Beach, Florida

Manager, Fill Finish Technical Operations
Job Details
Level
Management
Job Location
ADMA Biologics FL – Boca Raton, FL
Description ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Manager, Fill Finish Technical Operations in Boca Raton, FL! The Manager, Fill Finish Technical Operations is responsible for managing the process and providing technical support and guidance for the Fill/Finish teams and projects. Qualifications

ESSENTIALS OF THE JOB

Establish and maintain quality processes within Fill-Finish Operations
Develop or revise procedures as needed in conjunction with the Quality Department for filling and finishing. Ensure proper documentation, procedures, batch records, improve quality, and Fill-Finish manufacturing efficiency.
Establish weekly production schedules to ensure customer orders and product specifications are met.
Direct Validation efforts, interacting with Quality Control Directors, Technical Services and Quality Assurance.
Develop more efficient methods for departmental operations.
Responds to reports from internal/external audits.
Assign and supervise change controls or deviation reports as needed.
Review statistical data with Scientific and Technical Operations, based upon trends and development work, modify procedures using the change control and process validation systems for the goal of optimum yields and productivity.
Assure compliance with GMP including training, documentation and processes.
Interact with the management of VP of Supply Chain Operations to establish production schedules and protocols, and provide input into new facility design, operation, and upgrades.
Assist in preparation of Biological License Application for a new product.

Education Requirements:

Bachelor’s degree or equivalent level of technical training/service.

Experience Requirements:

10+ years of related experience with 3+ years in a managerial role or 6+ in a supervisory role. Knowledge of GMP’s and all aseptic filling and finishing equipment. Good interpersonal skills. Intermediate proficiency in quality document systems, word processing and spreadsheet packages. In addition to competitive compensation, we offer a comprehensive benefits package including: 401K plan with employer match and immediate vesting
Medical, Vision, Life and Dental Insurance
Pet Insurance Company paid STD and LTD
Company Paid Holidays 3 Weeks’ Paid Time Off (within the first year)
Tuition Assistance (after the first year)
Easily accessible to Tri-Rail
Company paid shuttle to the Boca Tri-Rail station ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify. ADMA Biologics is an Equal Opportunity Employer.