Manager/Sr Manager, Manufacturing
About The Position
Manages the day-to-day affairs of an organization by assisting the Director, Manufacturing in medium- and long-term scheduling, strategic lead on high profile projects, and to assess and respond to urgent operational issues. The individual will also be responsible for ensuring MRP transactions, manufacturing record reviews, maintenance activities, and compliance documents are completed timely and thoroughly. The individual will ensure that manufacturing records and materials are available for timely execution of activities to meet production schedules. This proven and qualified candidate will use their past experiences, depth and knowledge of biopharmaceutical operations to teach, troubleshoot, and continuously improve the production operations at the facility. The ideal candidate will be both technically sound as well as an experienced team motivator and coach. Demonstrated knowledge of mammalian cell culture, purification, and solution preparation activities is expected as the Manager/Sr. Manager will teach, promote and enforce precise and compliant operations. The Manager/Sr. Manager will use their leadership and technical expertise to drive process improvement initiatives, monitor processes and equipment, and troubleshoot issues, trend and track metrics and author, review and approve procedures, deviations, CAPAs, and change controls as needed.
Requirements
- Excellent written and verbal communication skills with application in a team-oriented environment are required.
- Energetic and motivated individual.
- Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor
- Manager: Bachelor’s degree in a related scientific or engineering discipline is preferred and 8+ years’ experience in related GMP manufacturing operations; 3+ years prior supervisory experience.
- 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 supervisory experience preferred.
Nice To Haves
- Demonstrated knowledge of purification operations is highly preferred.
- Experience in single-use platform technology is preferred.
- Experience with regulatory and client inspections is preferred.
Responsibilities
- Direct support to Director, Manufacturing on daily tasks.
- Strategic lead on high-profile projects
- Medium and Long – Term Scheduling
- Assess and respond to urgent operational issues.
- Inter Departmental coordination and scheduling support.
- Hiring manufacturing personnel.
- Support operations to ensure MRP transactions, manufacturing record reviews, and maintenance activities are completed timely and thoroughly.
- Support operations to ensure deviations, CAPAs, and Change Controls are completed timely and thoroughly.
- Training, coaching and mentoring manufacturing supervisors and associates.
- Identify and implement continuous improvement projects to increase safety, reliability, speed, and quality.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
