Bioprocess Manager

Description

Scope of Function:

The Bioprocess Manager position reports to the Vice President of Technical Operations and act as the Upstream Manufacturing, Manager. Prior experience in GMP manufacturing, operation of GMP process equipment and aseptic technique are prerequisites. This role is responsible for overseeing end-to-end Upstream cGMP process for antibody and human cells production, including media/buffer preparation, seed train, medium to large scale bioreactor runs through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk biologics from mammalian and cell culture systems for Phase I/II/III and commercial cGMP manufacturing.

Specific Duties:

• Collaborate with R&D and Process Development to transfer new monoclonal antibody processes and tech-transfers

• Foster a culture of safety, accountability, and innovation within the team

• Develop and implement robust production schedules, ensuring all deliverables align with project deadlines and quality standards

• Operates pharmaceutical manufacturing equipment such as: incubators, wave reactors, single-use and stainless-steel bioreactors, single use mixers, depth filtration skids, TFF skids, chromatography skids and in process testing equipment.

• Executes all Upstream Clinical Manufacturing and Development operations, including but not limited to work functions in cell culture, cell banking, media optimization, seed train preparation, bioreactor operations, harvest/clarification, and technology transfer to manufacturing.

• Demonstrates, understands, and adheres to Goodwin Biotechnology policies, GMP standards and safety procedures.

• Performs and monitors critical processes, execute manufacturing batch records (MBR) for specific projects to manufacture cell-derived biopharmaceuticals in compliance with cGMP guidelines and regulation.

• Author and/or oversee the development of batch records, SOP’s and protocols as required.

• Supports other manufacturing processes teams and other GBI groups as necessary to achieve manufacturing goals.

• Conduct performance reviews, identify training needs, and provide professional development opportunities to team members.

• Lead cross-functional meetings to align upstream production with other departments, including downstream processing, QC, and supply chain

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned at any time with or without notice. 

Requirements

Education and Experience Required:

• Bachelor’s or Master’s degree in Biochemical Engineering, Biotechnology, Biochemistry, or a closely related life sciences discipline.

• Minimum of seven (7) years of experience with biologic Upstream production processes under GMP compliance with a minimum of two (2) years of supervisor/manager experience

• Excellent documentation skills including comprehension and review & establishing batch production records.