Senior Process Engineer, Process Development

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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 Process Engineer, Process Development located in Boca Raton, FL!

Job Title : Senior Process Engineer, Process Development

Job Description : Position Summary

The Senior Process Engineer, Process Development , will play a critical role in supporting the development and transfer of processes for IgG Immunotherapy Production. This position will regularly update the Process Development (PD) Management team to ensure compliance and operational efficiency. Responsibilities include maintaining compliance in the PD laboratory and executing process development, evaluation studies, and process validations using a scale-down model. As a key member of the PD team, this role will support Manufacturing, Quality Control / Assurance, and Regulatory departments.

Essential Functions (ES) and Responsibilities

• Provide technical support for issues related to the manufacturing process and product quality.
• Develop new processes as needed for the production of plasma-derived therapies.
• Ensure familiarity with regulatory guidelines for process development and validation and implement necessary manufacturing process changes.
• Optimize and maintain compliance in the PD laboratory by ensuring that all equipment calibration, IQ, OQ, and PM statuses are up to date.
• Participate in the design and planning of scientific experiments to meet corporate goals for existing projects.
• Review and / or approve cGMP documentation generated by other members of the PD group as needed.
• Lead the execution of process development and evaluation studies, as well as process validations using a qualified scale-down model.
• Oversee the transfer of process changes and / or new processes from PD to Manufacturing.
• Act as a liaison between PD and Manufacturing to support deviations, investigations, and process transfers.
• Maintain and review process development batch records for scale-down process models.
• Perform additional activities as assigned by PD Managers.
• Support Manufacturing, Engineering, and Quality Management in the development and implementation of new processes and technologies.
• Assist manufacturing personnel in executing process development and process validation studies within a cGMP production environment.

Job Responsibilities or Job Requirements

Competencies

Ability to follow the cGMP's and procedures with great attention to detail

Able to work in high-pressure, deadline-driven environment

Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines

Possess time management skills and be able to balance multiple job assignments at once

Possesses excellent oral and written communication skills with close attention to detail and accuracy to collaborate effectively with cross-functional teams and communicate findings and recommendations

Experience Requirements

Education Requirements :

Experience Requirements :

Preferred Experience

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.

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In addition to competitive compensation, we offer a comprehensive benefits package including :

ADMA Biologics, Inc. 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.