Manufacturing Supervisor – Aseptic Upstream Bioprocessing

Elanco•Elwood, KS

2d•Onsite

About The Position

The Manufacturing Supervisor – Aseptic Upstream Bioprocessing is responsible for leading manufacturing personnel and daily operations supporting the aseptic production of monoclonal antibody (mAb) products at Elanco's Elwood, Kansas manufacturing site. This role oversees production activities across upstream bioprocessing operations, ensuring production targets are achieved while maintaining the highest standards of safety, quality, regulatory compliance, and Good Manufacturing Practices (cGMP). The supervisor also plays a key role in developing team members, driving operational excellence, and fostering a culture of accountability and continuous improvement.

Requirements

High School Diploma or equivalent required.
Experience leading or supporting manufacturing operations in a regulated production environment, with demonstrated success supervising teams, maintaining production schedules, and ensuring compliance with quality and safety standards.
Strong leadership and people development capabilities.
Ability to manage manufacturing operations while maintaining compliance with cGMP, safety, and quality requirements.

Nice To Haves

Bachelor's degree in Biology, Chemistry, Engineering, Biomanufacturing, or a related scientific discipline.
3–5+ years of experience in commercial GMP biomanufacturing, including aseptic processing, cell culture, downstream purification, final formulation, or fill/finish operations.
Knowledge of USDA, FDA, and EU GMP regulations governing biologics or sterile manufacturing.
Experience leading investigations, root cause analysis, and continuous improvement initiatives in a manufacturing environment.
Strong communication, coaching, and cross-functional collaboration skills with the ability to develop high-performing teams.

Responsibilities

Lead and oversee daily manufacturing operations supporting aseptic bioprocessing activities, including cell expansion, production, upstream processing, while partnering with downstream and fill finish and ensuring adherence to production schedules.
Supervise, coach, and develop manufacturing personnel through performance management, training, and regular feedback to build a high-performing, engaged team.
Ensure manufacturing activities are performed in compliance with USDA, EMA, and cGMP requirements, approved procedures, and batch production records.
Maintain a strong presence on the production floor to promote safe work practices, operational excellence, and a culture of quality and accountability.
Coordinate with Quality, Engineering, Maintenance, Validation, Supply Chain, and other cross-functional teams to support compliant and efficient manufacturing operations.
Monitor production performance, equipment readiness, and schedule adherence while ensuring timely completion of batch records, SAP transactions, and manufacturing documentation.
Lead or support investigations, root cause analyses, and corrective and preventive actions (CAPA) for operational events, deviations, and equipment or process issues.
Drive continuous improvement initiatives that enhance manufacturing efficiency, strengthen compliance, and improve overall operational performance.