Senior Process Engineer, Process Development

Job Details
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 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 detailAble to work in high-pressure, deadline-driven environmentDemonstrated ability to achieve goals, overcome obstacles, and meet deadlinesPossess time management skills and be able to balance multiple job assignments at oncePossesses excellent oral and written communication skills with close attention to detail and accuracy to collaborate effectively with cross-functional teams and communicate findings and recommendationsExperience Requirements Education Requirements:

• Bachelor's degree in Science, Engineering, or a related field is required.

Experience Requirements:

• A minimum of 10 years of experience in a cGMP Pharmaceutical/Biological manufacturing environment.
• Strong familiarity with various aspects of process development and a thorough understanding of FDA cGMP requirements is required.

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.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, 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 . ADMA Biologics is an Equal Opportunity Employer. Company
ADMA Biologics is an end-to-end commercial biopharmaceutical company committed to manufacturing, marketing and developing specialty plasma-derived products for the prevention and treatment of infectious diseases in the immune compromised and other patients at risk for infection. Our devotion to these underserved populations fuels us, and our hands-on approach to production and development sets us apart.
Company info
Website Phone Location 5800 Park of Commerce Blvd. NW
Boca Raton, FL 33487
US
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