The individual will be responsible for supervision of operators performing aseptic filling activities across 2-3 fill lines as well as visual inspection operations. The incumbent will be responsible for a diverse manufacturing team performing routine cGMP filling of viral vectors supporting gene and cell therapy products including Adeno-Associated Virus (AAV) and Lentivirus (LV) and provide leadership across both viral vector and cell therapy manufacturing. The individual should be a motivated self-starter eager to contribute to building a manufacturing operation unparalleled in its capabilities and expertise, have a willingness and aptitude for adoption of new technology, an ability to build relationships and work effectively in a cross-functional team, and commitment to the highest safety and quality standards.
- Provide daily supervision of a team of 10-12 operators performing aseptic filling activities and visual inspection of vials. 90% of time will be spent on the manufacturing floor.
- Work with a cross-functional team of process development, engineering, quality, etc. for the execution of cGMP-appropriate, scalable viral vector manufacturing processes.
- Maintain aseptic gowning qualifications and train on all aspects of the aseptic filling process. Be qualified to perform process as needed.
- Lead operational staff, develop staff capabilities, create a culture of safety, continuous improvement and training objectives, and compliance.
- Establish key performance indicators in alignment with individual, department, and company goals; maintain and report organizational metrics.
- Proactively identify and escalate key risks and issues to shift manager.
- Work effectively with cross functional teams comprised of process sciences, development, facilities & engineering, tech ops, quality control, and quality assurance to ensure right-first-time execution.
- Identify risks and propel continuous improvements in development and manufacturing processes through technological innovation and alignment with regulatory requirements for clinical and commercial vector manufacturing.
- Ensure high levels of communication with the team, support resources, and management regarding issue identification and resolution.
- Work closely with the production staff to troubleshoot process and equipment problems.
- Support the team in defining and executing technical strategies.
- Work closing with Quality Assurance and to proactively resolve issues such as deviations, CAPAs, and Change Controls.
- Support the initial and ongoing training of staff.
- Proactively identify opportunities for improvements in process, safety, quality, and cost.
- Requires a willingness to work off-shift as required by business demand and manager request.
- Bachelor’s degree (in biological science(s) field or related engineering) is preferred but not required
- 3-4 years of experience in cGMP biotech manufacturing
- 1-2 years of proven leadership experience
- Experience with MES and integrated automation in manufacturing preferred
- Outstanding communication skills (verbal and written)
- Experience with some or all the following: cGMP manufacture using equipment such as automated and semi-automated aseptic fill lines, isolators, visual inspection light stations, and filter integrity testing equipment.