Group Leader, Automated Laboratory Testing

4 weeks ago

Boca Raton, United States ADMA Biologics Full time
Job DetailsLevel ExperiencedJob Location ADMA Biologics FL - Boca Raton, FLPosition Type Full TimeEducation Level 4 Year DegreeTravel Percentage NoneJob Shift DayJob Category PharmaceuticalDescription

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 Automated Laboratory Testing Group Leader in Boca Raton, FL

 

The Automated Laboratory Testing Group Leader provides leadership and hands-on management for the automated donor testing laboratory to support hyperimmune products for ADMA Biologics. This position is responsible for the receipt, testing and on-time delivery of donor testing, maintaining a cGMP compliant laboratory, troubleshooting assays and liquid handling robotics (Hamilton Company) as needed, oversight of testing analysts, and maintaining cross-function relationships with both plasma centers and ADMA plasma operations. Qualifications

Requires specialized knowledge of liquid handling robotics for fully automated workflows, knowledge in the processing and testing of donor plasma samples, and experience with immunological assays, such as ELISA. Management of sample submission, sample handling and storage, and data reporting. Development of design tools to streamline the sample management process. Ability to work accurately in a fast-paced environment to meet the requirements of quality and quantity. Analyze data and adhere to strict guidelines on documentation when recording, reviewing, and submitting data. Ability to work with laboratory information management systems to schedule testing, perform data review, and release results. Review and approve cGMP documentation generated by analysts or technicians and ensures data integrity by completeness, consistency, and accuracy of documents within quality systems. Maintains compliance with standard operating procedures, regulatory requirements, and internal company procedures. Develop a clear understanding of business and user requirements for improving efficiency, throughput, and quality for sample processing workflows. Responsible for assigning tasks and overseeing and training analysts or technicians to perform routine high throughput screening assays on automated instrumentation in a quality control laboratory. Develop schedules and complete performance assessments. Be able to perform or manage required maintenance of robotic workstations and integrated analytical instrumentation, such as spectrophotometers and microplate washers, and is familiar with robotics liquid handling hardware and software programs. Proven ability to troubleshoot liquid handling systems and experience with diagnosing problems in analytical platforms. Assist in the management, planning, and tracking of specific project activities. Ability to adhere to timelines and milestones while maintaining efficiency and organization. Frequently communicates status updates across the organization and reports the working conditions of the instrumentation to ensure time requirements are met. Use judgment, creativity, and sound technical knowledge to obtain and recommend solutions to problems as directed by upper level management. Provides relevant technical skills, interest in team management, effective in problem solving, builds cross-functional relationships, and maintains active communication skills. Be familiar with Biosafety Level 2 (BSL-2) Laboratories and working a BSL-2 environment. Be aware of and keep up to date with health and safety issues in all aspects of the work undertaken.

 

Education Requirements:   

Bachelor of Science Degree or related science discipline.

 

Experience Requirements:

5+ years in cGMP environment with knowledge of assay automation (preferably Hamilton), and experience in testing using immunological methods, such as ELISA. Management experience is preferred. Experience working in a source plasma testing facility is a plus. Experience with drafting protocols and drafting and reviewing quality control documents. Ability to navigate in a fast-paced demanding environment. Possess strong verbal and written communication skills.

 

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 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.

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