Supervisor, Manufacturing

Arbeitsbeschreibung

We are seeking a highly effective Supervisor, Manufacturing to be responsible for supervising a team of cell therapy manufacturing specialists in our state-of-the-art commercial biotechnology facility in Frederick, MD.

In this role, the Supervisor will supervise the on-the-floor operations of our commercial cell therapy manufacturing facility in a cGMP environment including developing a team, and providing the necessary training and ongoing coaching, performance management and recognition of direct staff, including performing annual performance reviews.

**Shift – Sun- Wed, 1500-0130**

Responsibilities (include but are not limited to):

• Supervise the on-the-floor operations of our commercial cell therapy manufacturing facility in a cGMP environment
• Build a team, provide necessary training and ongoing coaching, discipline and recognition of direct staff, including performing annual performance reviews
• Generate SOPs, MPRs, and SPRs for equipment and procedures used in routine biologics manufacture
• Execute production and resource schedule against operational plan
• Ensure performance of all process steps specific to the phase or stage of operation
• Process monitoring, including manipulation of databases, documents and/or spreadsheets to support business reporting requirements
• Review of completed manufacturing documentation per compliance standards and established timelines
• Investigate and resolve problems, identifying root cause, and proposing process improvements through clear communication to senior management
• Interact with outside vendors and senior management
• Participate in multi-functional project teams, as necessary
• Take corrective action to bring about required changes using change control procedures
• Other duties as assigned
  

Basic Qualifications:

• Master’s and 3+ years of relevant experience OR
• Bachelor’s and 5+ years of relevant experience

Preferred Qualifications:

• Able to build and lead a team as well as train entry-level personnel
• Knowledgeable of the current Code of the Federal Regulations (CFR's) and Current Good Manufacturing Practices (cGMP's)
• Sufficient understanding of process, systems and equipment to troubleshoot problems and provide solutions to senior management
• Sufficient knowledge of electronic quality systems
• Must be able to work on off shift hours as well as part of the on-call rotation as needed is required; weekend shift likely
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
• Willingness to think outside of the box and adapt best practices to our small, but growing environment
• Ability to adapt in a constantly evolving environment
• Self-motivated with a strong sense of ownership in areas of responsibility
• Previous cell culture experience preferred/highly desired

Does this sound like you? If so, apply today!