Manufacturing Supervisor

Job Title: Manufacturing Supervisor

Job Number: 33166

Location: San Diego, CA

Job Description

Responsibilities

Responsibilities
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, including performing 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 all personnel
Interact with outside vendors and senior staff members
Participate in multi-functional project teams, as necessary
Take corrective action to bring about required changes using change control procedures
Must be willing to work off shift as needed

Required Skills

Qualifications
Master’s degree with 3+ years of experience in manufacturing in a biotech/pharma industry Or
Bachelor’s degree with 5+ years of experience in manufacturing in a biotech/pharma industry Or
High School degree with 9+ years of experience in manufacturing in a biotech/pharma industry
 
Preferred Qualifications
Two years of experience supervising staff
Able to develop 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
Able to work on off shift hours as well as part of the on-call rotation as needed
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 deep sense of ownership in areas of responsibility