- Oversee the daily fractionation and purification manufacturing process in the production of plasma derived products.
- Manage the quality system and compliance processes for both processes including training, deviations, investigations, root cause analysis and change controls.
- Develop to be subject matter expert in biologic protein fractionation and purification technologies.
- Partner with support groups to continuously improve safety and quality to meet department goals.
- Responsible for meeting production requirements including fulfillment and yield targets.
- Assist Department Leaders with creation and meeting the annual operation plan and budget commitments.
- Ensure staff training is appropriate to perform tasks with highest level of safety, quality, and compliance.
- Responsible for driving right first-time execution.
- Responsible for representing department and providing leadership in meetings, audits, and projects as required.
- Required to own and lead various operations related projects and/or initiatives to on-time completion.
- Work closely with department leaders and peers and interfaces to fill in for leaders and peers as required.
- 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.
- Stay current on industry trends.
- 10+ years of experience in pharmaceutical or biotechnology with emphasis on cGMP manufacturing and aseptic techniques
- Must have demonstrated interpersonal and leadership skills with the ability to interface well with personnel at all levels.
- Must have demonstrated leadership skills with coaching and development for leading a high performing team.
- Must have demonstrated project management skills and/or project delivery skills.
- Must be able to work and facilitate a team-oriented environment.
- Knowledge of Good Manufacturing Practices and Food and Drug Administration regulations.
- 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
- ADMA Biologics is an Equal Opportunity Employer.
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Manager, Production Operations - Boca Raton - ADMA BIOMANUFACTURING LLC
Description
Job Description Header:
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 Manager, Production Operations in Boca Raton, FL
Job Title: Manager, Production Operations
Job Description:
Position Summary
The Manager, Production Operations will manage 24/7/365 Plasma Fractionation and Purification operations. This position is responsible for managing the process and providing technical support and guidance to the Manufacturing Managers, Supervisors and Group Leaders. Support the coordination of process improvements, utilizing the quality system as required. Drive a strong cGMP environment on the production floor.
Essential Functions (ES) and Responsibilities
Competencies
Ability to follow the cGMP's and procedures with great attention to detail
FDA Adherence
Strong organizational, interpersonal and collaborative skills
Experience Requirements
Education Requirements: Bachelor's degree or equivalent level of technical training/service
Experience Requirements:
Preferred Education Requirements: Bachelor's degree in science, engineering, or another related technical field preferred
Preferred Experience: Experience in all aspects of Manufacturing preferred (Bulk, Purification, Filling Operations)
Compliance Requirements (ES)
The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.
Job Description Footer:
In addition to competitive compensation, we offer a comprehensive benefits package including:
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