Supervisor, Manufacturing (Front-End Day Shift)

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.

**This position is for front-end day shift (Sunday - Wednesday, from 6:00am to 4:30pm)**

Responsibilities of the Supervisor of Cell Therapy Manufacturing include:

• Provide oversight and/or supervision for the on-the-floor operations of cell therapy manufacturing in a cGMP environment.

• Build a team, provide leadership, guidance, and necessary training to staff in alignment with cGMP requirements.

• Support the review and approval of procedural changes within controlled documentation.

• Clear communication with outgoing and incoming shift supervisors to disseminate all relevant information.

• Support the review and approval of procedural changes within controlled documentation.

• Participate in multi-functional project teams, as necessary.

• Responsible for oversight of on-the-floor execution of protocol driven production activities within manufacturing (APVs, PPQs, Engineering Runs, etc.)

• Execute production and resource schedule against operational plan

• Ensure performance of all process steps are in compliance with applicable SOPs, policies, and governing documents.

• 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 leadership.

• Take corrective action to bring about required changes using change control procedures.

• Support cross-functional meetings to ensure manufacturing representation as needed.

• Additional duties as assigned.

• These duties can be delegated to designated deputies of a satisfactory qualification level as needed.

Basic Requirements:

MA / MS with 3+ years of cGMP Manufacturing and/or Manufacturing Leadership and/or Operations experience

OR

BA / BS Degree with 5+ years of cGMP Manufacturing and/or Manufacturing Leadership and/or Operations experience

OR

Associate and 7+ years of cGMP Manufacturing and/or Manufacturing Leadership and/or Operations experience

OR

High School Degree with 9+ years of cGMP Manufacturing and/or Manufacturing Leadership and/or Operations experience

Preferred Qualifications:

• 5+ years of experience supervising staff

• 9+ years of experience in manufacturing in a biotech/pharma industry

• Proven capability 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 batch record, ERP and quality systems

• Able to work evening to late mid night hours as well as part of the on-call rotation as needed is required; partial weekend shift

• Excellent interpersonal, verbal and written communication skills are important 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 standard methodologies to our small, but growing environment

• Ability to adapt in a constantly evolving environment

• Self-motivated with a deep sense of ownership in areas of responsibility

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