Supervisor, Manufacturing

Job Description

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.

**This position is for Front-end Swing shift (Sunday to Wednesday, from 3:00PM to 01:30 AM)

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

People Leader Accountabilities

•Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

•Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.

•Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.