Supervisor, IgG Manufacturing Purification

Location
Boca Raton, FL
Posted
Jul 13, 2021
Ref
27345
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 Supervisor, IgG Manufacturing Purification in Boca Raton, FL!

 

This position is responsible for supervising a team of manufacturing technician and Group Leader positions producing FDA licensed IgG injectable bulks, intermediate fractions, contract manufacturing and clinical products under GMP compliant conditions as required to meet the ADMA production plan.

Qualifications
  • Oversee the manufacture of IgG plasma intermediates and / or bulk products within cGMP guidelines.
  • Supervise Mfg. Technician and Group Leader positions. Manage requests for time off. Prepare annual performance appraisals and recommend salary increases. Review and approve timecards to ensure compliance with attendance policy. Handle disciplinary measures for staff as well as promotion recommendations. Interview and participate with managers in hiring staff.
  • Provide on the job training, technical training, assessment of progress and coaching. Work with trainers to assure development of proper work and documentation practices and identification of specific individual training needs for all team members.
  • Maintain a clean, GMP compliant and safe working environment.
  • Assure timely and accurate initiation and completion of quality system documents (deviations, CAPAs, Change Controls, Temp Variances, etc.) as assigned / required.
  • Provide shift leadership and sound judgement and decision-making regarding quality, processing, capacity, personnel, and any other issues as they arise with appropriate consultation with and notification to management. 
  • Take ownership of and responsibility for the area, facilities, equipment and processes during shifts. Assure facilities and equipment are operated, cleaned and maintained at a GMP compliant level.
  • Prepare team and individual work schedules and coordinate assignments to maximize production efficiency while maintaining high quality and documentation standards. Coordinate personnel and resources on a day-to-day basis to accommodate the work schedule. 
  • Coordinate related work and scheduling with other departments including but not limited to Warehouse, Plasma Ops, QC, QA, PD, Eng Facilities, EHS, IT, Finance and HR.
  • Evaluate workload and assign tasks to technicians on a daily basis.
  • Must comprehend and understand automation systems (PAS), CIPs, HMIs, etc. and possess mechanical aptitude to troubleshoot the type of problems associated with departmental processes and equipment.
  • Prioritize work based on production schedule and meet deadlines.
  • Assure that all appropriate logs and batch records are completed accurately and in a timely fashion per appropriate SOPs.
  • Troubleshoot work related problems to ensure that delays are avoided whenever possible, and issues are properly documented.
  • Assure that raw materials that are needed for production are available in a timely manner so that adequate supplies are available to avoid production delays.
  • Protect integrity and quality of product, elevating problems appropriately to management as needed to assure production decisions are made at the proper level.
  • Be capable of reviewing both corporate policies and technical procedures, and successfully train and/or communicate pertinent information to subordinates.
  • Assure all employees are in compliance with Standard Operation Procedures and meeting job descriptions, and ADMA policies and procedure requirements.
  •  Administer and prioritize any changes necessary to comply with personnel policies and procedures and Standard Operating Procedures as established by the company.  Review new and revised procedures before they are finalized.
  • Establish and monitor new employee training and verify appropriate new employee documentation is complete and properly filed.  Assure proficiency testing for employees are up to date. Ensure consistent training and operational practices between shifts.
  • Assure that the Department Managers, are updated as to the status of the workflow, any problem areas, personnel difficulties, exceptional performance, and any operational information as required by the Manager.
  • Perform Timecard review for all employees that report to the supervisor.

 

Education Requirements:                 

Bachelor’s Degree in related field preferred. (Plasma Product Mfg. experience at Tech III / Group Leader equivalent experience or higher can offset education requirement).

 

Experience Requirements:                

Minimum of 4 years in Plasma Product manufacturing at a tech III level (or higher) or related manufacturing and supervisory experience desired.

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