Senior Scientist, Production Operations

Company: ADMA Biologics
Location: Boca Raton
Posted on: December 31, 2025

Job Description:

Job 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 Senior Scientist, Production Operations in Boca Raton, FL! Job Title: Senior Scientist, Production Operations Job Description: Position Summary The Senior Scientist, Production Operations will lead and provide technical support for departmental projects, change controls, risk assessments, deviations, CAPAs and audits. Thie role will drive and/or coordinate process improvements, utilizing the quality system as required. Generate and analyze trend reports on production processes (both in-process and FIN) as needed and track effectiveness of changes. Support a strong cGMP environment. Essential Functions (ES) and Responsibilities Develop subject matter expertise in biologic protein fractionation, purification, and fill finish technologies to support Production Operations. Technical lead for all departmental projects, change controls, risk assessments, deviations, CAPAs, and audit support. As needed provide data/analysis to support groups including: MQA, PD, Regulatory Affairs, Microbiology, Engineering and Validation. Utilize project management skills to track progress of projects to ensure milestones are met. Drive process improvements. Take charge of assigned projects and be able to work with other departments to ensure completion by the deadline set and communicate status on a routine basis. As needed analyzes quality indicators, including yields, microbial data, environmental monitoring, deviations, etc., evaluates information relating to process conditions and assesses their state of control. Support the development of training strategies and materials for manufacturing and support teams as needed. Work closely with department leaders and peers and interfaces to fill in for leaders and peers as required. Partner with support functions to continuously improve safety and quality to meet ADMA goals. Stay current on industry trends. Job Responsibilities or Job Requirements Competencies Ability to follow the cGMP’s and procedures with great attention to detailFDA AdherenceStrong organizational, interpersonal and collaborative skillsExperience Requirements Education Requirements: Bachelor’s degree in science, engineering, or another related technical field preferred Experience Requirements: 10 years of experience in Plasma Fractionation or Purification or Fill Finish Operations Experience in all aspects of Manufacturing preferred Knowledge of world-class manufacturing methods (QLP, Lean, Six Sigma), DMAIC, Good Manufacturing Practices, Food and Drug Administration regulations Must have demonstrated interpersonal and leadership skills with the ability to interface well with personnel at all levels. Must be able to work and facilitate a team-orientated environment. Must have demonstrated project management skills and/or project delivery skills. Preferred Experience Compliance Requirements (ES) As a part of our Quality Systems and cGMP initiatives, employees are responsible for ensuring compliance with all ADMA Quality policies, standards, SOPs, in their area of work and responsibility. This includes ensuring all Quality Assurance(QA) records and reports, Human Resources (HR) policies, and Environmental Health and Safety (EH&S) procedures and practices are completed in a timely manner, Any delay or failure to comply with policies, standards and procedures is required to be communicated/escalated to the appropriate responsible parties such as QA, HR, or EH&S depending on the issue. Job Description Footer: 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. Free 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.

Keywords: ADMA Biologics, Boca Raton , Senior Scientist, Production Operations, Science, Research & Development , Boca Raton, Florida