BioSpace
Job Overview
Senior Scientist, Production Operations
at ADMA Biologics, Boca Raton, FL.
ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. We pride ourselves on a hands‑on approach to production and development.
Position Summary The Senior Scientist, Production Operations will lead and provide technical support for departmental projects, change controls, risk assessments, deviations, CAPAs, and audits. They will drive and/or coordinate process improvements, utilizing the quality system as required, generate and analyze trend reports on production processes, and support a strong cGMP environment.
Essential Functions & 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.
Provide data/analysis to support groups including MQA, PD, Regulatory Affairs, Microbiology, Engineering and Validation.
Utilize project management skills to track progress of projects and ensure milestones are met.
Drive process improvements and take charge of assigned projects, working with other departments to ensure completion by the deadline and communicate status on a routine basis.
Analyze quality indicators, including yields, microbial data, environmental monitoring, deviations, etc., evaluate information relating to process conditions and assess 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 interface 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.
Qualifications 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, FDA regulations.
Demonstrated interpersonal and leadership skills with the ability to interface well with personnel at all levels.
Ability to work and facilitate a team‑orientated environment.
Demonstrated project management skills and/or project delivery skills.
Compliance Requirements As 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 QA records and reports, Human Resources policies, and Environmental Health and Safety procedures and practices are completed in a timely manner. Any delay or failure to comply must be communicated and escalated to the appropriate responsible parties such as QA, HR, or EH&S.
Benefits
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.
Seniority Level Mid‑Senior level
Employment Type Full
Job Function Research, Analyst, and Information Technology
Industries Internet News
Equal Opportunity Employer (EEO) Statement ADMA Biologics uses E‑Verify to confirm the employment eligibility of all newly hired employees. ADMA Biologics is an Equal Opportunity Employer.
To learn more about E‑Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.
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at ADMA Biologics, Boca Raton, FL.
ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. We pride ourselves on a hands‑on approach to production and development.
Position Summary The Senior Scientist, Production Operations will lead and provide technical support for departmental projects, change controls, risk assessments, deviations, CAPAs, and audits. They will drive and/or coordinate process improvements, utilizing the quality system as required, generate and analyze trend reports on production processes, and support a strong cGMP environment.
Essential Functions & 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.
Provide data/analysis to support groups including MQA, PD, Regulatory Affairs, Microbiology, Engineering and Validation.
Utilize project management skills to track progress of projects and ensure milestones are met.
Drive process improvements and take charge of assigned projects, working with other departments to ensure completion by the deadline and communicate status on a routine basis.
Analyze quality indicators, including yields, microbial data, environmental monitoring, deviations, etc., evaluate information relating to process conditions and assess 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 interface 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.
Qualifications 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, FDA regulations.
Demonstrated interpersonal and leadership skills with the ability to interface well with personnel at all levels.
Ability to work and facilitate a team‑orientated environment.
Demonstrated project management skills and/or project delivery skills.
Compliance Requirements As 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 QA records and reports, Human Resources policies, and Environmental Health and Safety procedures and practices are completed in a timely manner. Any delay or failure to comply must be communicated and escalated to the appropriate responsible parties such as QA, HR, or EH&S.
Benefits
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.
Seniority Level Mid‑Senior level
Employment Type Full
Job Function Research, Analyst, and Information Technology
Industries Internet News
Equal Opportunity Employer (EEO) Statement ADMA Biologics uses E‑Verify to confirm the employment eligibility of all newly hired employees. ADMA Biologics is an Equal Opportunity Employer.
To learn more about E‑Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.
#J-18808-Ljbffr