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

Experience 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.