Position Summary:The Manager/Sr. Manager, Manufacturing Specialists is responsible for providing technical leadership and oversight of the quality systems for the Manufacturing department. The Manager leads a team of compliance and technical specialists, possesses proven technical writing and problem-solving skills, and has a drive for continuous improvement. The Manager has experience using single-use disposable technologies and an understanding of upstream processing, downstream processing, and general biomanufacturing support principles. From a technical perspective, the Manager leads a team responsible for system ownership activities such as generating manufacturing procedures and records, supporting procurement and enrolling of manufacturing equipment, driving operational excellence initiatives and other activities required of responsible system owners. From a compliance perspective, the Manager leads a team that supports thorough and robust manufacturing investigations, implement effective corrective/preventative actions, lead manufacturing compliance and safety walkthroughs, oversee internal and external audits, and manage manufacturing change controls. The Manager is responsible for ensuring their staff works crossfunctionally with QA, MS&T, Engineering, Supply Chain, IT, AFS and other key departments to ensure manufacturing operations are successful, reliable, and compliant. This requires a drive for continuous improvement, simplicity and superior equipment and human performance.
Responsibilities:- Manage, train and mentor a team of Manufacturing Specialists that implement thorough and effective corrective and preventative actions, drive training initiatives around compliance and support post-execution review of manufacturing records/data. Oversee the team as they take responsibility for performing area walkthroughs and manage inspection readiness and audit responses and actions.
- Manage, train and mentor a team of Manufacturing Specialists that generates manufacturing procedures and records, drives operational excellence initiatives, supports procurement and enrollment of manufacturing equipment, support comprehensive investigations to determine root cause/product impact, and performs other activities as responsible system owners.
- Drive process improvement initiatives, troubleshoot issues, track and trend metrics, and author/review/approve technical documents, procedures, CAPAs, and change controls.
- Supervise, coach, mentor, and train team members to maintain educated, qualified, and motivated employees. Ensure staff maintain a high level of compliance to procedures and quality expectations.
Requirements:Sr. Manager- Bachelor's degree in a related scientific or engineering discipline is preferred and 10+ years' experience in related GMP manufacturing operations; 5+ years prior leadership/supervisory experience (preferred).
Demonstrated knowledge of cell culture, fermentation, or purification unit operation is preferred. Experience in single-use platform technology is preferred. Excellent written and verbal communication skills are required. Energetic, motivated and dynamic individual. Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.
Salary Range:XXXXXXXXXX For Manager
XXXXXXXXXX For Senior Manager
Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs.
