Manager / Sr. Manager, Manufacturing Specialists

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

• 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.

Qualifications

Commensurate with experience.

Skills

N/A

Benefits

N/A

Pay

Manager: $118,000-$153,400
Senior Manager: $133,000-$183,700

Schedule

N/A