Manufacturing Supervisor

职位描述

We are seeking a Supervisor, Manufacturing to be responsible for supervising a team of Cell Therapy Specialists in a clinical manufacturing environment.

Responsibilities:

· Supervise the on-the-floor operations of our clinical cell therapy manufacturing facility in a cGMP environment

· Schedule personnel resources according to operational plan

· Build a team, provide necessary training and ongoing coaching, discipline and recognition of direct staff, including performing annual performance reviews

· Generate SOPs, MPRs, and Work instructions for equipment and procedures used in biologics manufacturing

· 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

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

· Other duties as assigned

Basic Qualifications:

· Master’s Degree and 3+ years’ experience in biology OR manufacturing in a biotech/pharma industry OR

· Bachelor’s Degree and 5+ years’ experience in biology OR manufacturing in a biotech/pharma industry OR

· High School Degree and 9+ years’ experience in biology OR manufacturing in a biotech/pharma industry

Preferred Qualifications:

· 2+ years of experience supervising staff

· Previous cell culture experience

· 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)

· Understanding of process, systems and equipment to troubleshoot problems and provide solutions to senior management

· Knowledge of electronic quality systems

· Ability to work off shift hours, on-call rotation, weekend shifts

· Excellent interpersonal, verbal and written communication skills

· Provide and adapt best practices to our small and growing environment

· Ability to adapt in a constantly evolving environment

· Self-motivated with a strong sense of ownership in areas of responsibility