ADMA Biologics, Inc.
Senior Scientist, Production Operations – ADMA Biologics, Inc.
Boca Raton, FL
Company Overview
ADMA Biologics is a biopharmaceutical company committed to creating superior products for immunodeficient patients at risk for infection. The company’s hands‑on approach to production and development sets it apart. Position Summary
The Senior Scientist, Production Operations will lead and provide technical support for departmental projects, change controls, risk assessments, deviations, CAPAs, and audits. The role will drive process improvements and support a strong cGMP environment. Essential Functions & Responsibilities
Develop subject‑matter expertise in biologic protein fractionation, purification, and fill‑finish technologies. Technical lead for all departmental projects, change controls, risk assessments, deviations, CAPAs, and audit support. Provide data and analysis to support groups including MQA, PD, Regulatory Affairs, Microbiology, Engineering, and Validation. Utilize project‑management skills to track project progress and ensure milestones are met. Drive process improvements and communicate status routinely. Analyze quality indicators and assess process control state. Support training strategy development for manufacturing and support teams. Collaborate with department leaders and fill in for leaders and peers as required. Partner with support functions to continuously improve safety and quality. Stay current on industry trends. Qualifications
Bachelor’s degree in science, engineering, or related field (preferred). 10+ years of experience in plasma fractionation, purification, or fill‑finish operations. Experience in all aspects of manufacturing (preferred). Knowledge of world‑class manufacturing methods (QLP, Lean, Six Sigma), DMAIC, GMP, and FDA regulations. Demonstrated interpersonal, leadership, and team‑orientated skills. Project‑management experience or delivery skills. Preferred Experience
Experience in manufacturing, quality system, and cGMP initiatives. Compliance Requirements
Employees are responsible for ensuring compliance with all ADMA Quality policies, SOPs, and related standards. QA records and reports, HR policies, and EH&S procedures must be completed timely. Delays must be escalated to the appropriate parties. Benefits
401(k) 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 (first year) Tuition assistance (after first year) Free shuttle to Boca Tri‑Rail station and Tri‑Rail access ADMA Biologics uses E‑Verify to confirm employment eligibility. Equal Opportunity Employer. Seniority Level
Mid‑Senior Level Employment Type
Full‑time Job Function
Research, Analyst, and Information Technology
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ADMA Biologics is a biopharmaceutical company committed to creating superior products for immunodeficient patients at risk for infection. The company’s hands‑on approach to production and development sets it apart. Position Summary
The Senior Scientist, Production Operations will lead and provide technical support for departmental projects, change controls, risk assessments, deviations, CAPAs, and audits. The role will drive process improvements and support a strong cGMP environment. Essential Functions & Responsibilities
Develop subject‑matter expertise in biologic protein fractionation, purification, and fill‑finish technologies. Technical lead for all departmental projects, change controls, risk assessments, deviations, CAPAs, and audit support. Provide data and analysis to support groups including MQA, PD, Regulatory Affairs, Microbiology, Engineering, and Validation. Utilize project‑management skills to track project progress and ensure milestones are met. Drive process improvements and communicate status routinely. Analyze quality indicators and assess process control state. Support training strategy development for manufacturing and support teams. Collaborate with department leaders and fill in for leaders and peers as required. Partner with support functions to continuously improve safety and quality. Stay current on industry trends. Qualifications
Bachelor’s degree in science, engineering, or related field (preferred). 10+ years of experience in plasma fractionation, purification, or fill‑finish operations. Experience in all aspects of manufacturing (preferred). Knowledge of world‑class manufacturing methods (QLP, Lean, Six Sigma), DMAIC, GMP, and FDA regulations. Demonstrated interpersonal, leadership, and team‑orientated skills. Project‑management experience or delivery skills. Preferred Experience
Experience in manufacturing, quality system, and cGMP initiatives. Compliance Requirements
Employees are responsible for ensuring compliance with all ADMA Quality policies, SOPs, and related standards. QA records and reports, HR policies, and EH&S procedures must be completed timely. Delays must be escalated to the appropriate parties. Benefits
401(k) 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 (first year) Tuition assistance (after first year) Free shuttle to Boca Tri‑Rail station and Tri‑Rail access ADMA Biologics uses E‑Verify to confirm employment eligibility. Equal Opportunity Employer. Seniority Level
Mid‑Senior Level Employment Type
Full‑time Job Function
Research, Analyst, and Information Technology
#J-18808-Ljbffr