Associate Director, Fill Finish

Location
Boca Raton, FL
Posted
Jun 04, 2021
Ref
26715
Required Education
Bachelors Degree
Position Type
Full time

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 an Associate Director, Fill Finish in Boca Raton, FL!

 

The incumbent will manage daily operations of all aspects of the fill-finish operations, problem resolution, troubleshooting,  scheduling production.  Main fill-finish manufacturing interface for RA, QA, QC, FAC, VAL, PD, SC, and drug substance production.

 

ESSENTIALS OF THE JOB

 

  • Direct the work of fill-finish manufacturing personnel in the aseptic filling and product labeling, packaging, and serialization.            
  • 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, and 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.
  • Assigns and supervises 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.
  • Participate in pre-approval FDA inspection and comply with audit reports.

 

 

 

Qualifications

Education Requirements:                                 

Bachelor’s Degree in Engineering (preferred) or another scientific discipline.

 

Experience Requirements:                                

Eight or more years supervising an aseptic filling operation (required). Experience with automated filling equipment such as the Vanrx SA-25 is preferred.   

 

Other Essential Knowledge:             

Knowledge of GMPs 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, Inc. 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