Cell Therapy Manufacturing Supervisor - 2nd Shift

Duties And Responsibilities

Manages Partial to Full Shift Manufacturing Staff –includes performance reviews, team meetings, one on one meetings, development planning, coaching/mentoring, Manage PTO requests/Time Off, On-the-Floor Supervision, and training.

SME (Subject Matter Expert) Trainer on Manufacturing Unit Operations and Equipment.

First line of response for troubleshooting and cross-functional problem solving. Escalates to Line Manager as necessary.

Performs cell manufacturing related activities while wearing clean room attire in an aseptic cGMP manner.

Responsible for documenting all data in a compliant manner in MBR/eBRs and associated logbooks.

Responsible for authoring, editing, reviewing and/or approving manufacturing documents. These documents include but are not limited to:

• Training records
• Copies of patient batch records and the Certificates of Analysis of the Drug Product
• SOPs and Batch Record versions
• Equipment and other logbooks
• Validation documentation
• MEMOs, CAPAs/ Deviations
• Executed logbooks and Batch Records

Involved in Quality Output- May include but not limited to: Engagement in Compliance Forums (e.g. Aseptic Behaviors, GDP)

Works with the Quality team to author and review out of specification (OOS) reports, deviation investigations and corrective and preventative actions.

Daily scheduling of Manufacturing Operations including use of electronic systems (e.g. LIMS, SedApta, PAS-X, etc)

Qualifications

• Bachelor degree in a cell biology, bioengineering or medical technology related field, or equivalent experience is required.
• Minimum 3-year working with Advanced Cell Therapies within a cGMP environment.
• Ability to work flexible hours with some night and weekend availability is required.
• This is a start-up situation so schedules and shifts will change over time.
• Demonstrated strong understanding of GMP/GDP (21 CFR Part 210/211 & 21CFR Part 11)
• Ability to stand for multiple hours and lift 20 pounds.
• Experience with working in an aseptic cleanroom with full aseptic gowning.
• Excellent verbal and written communication skills are required.
• Computer literacy is required including Microsoft Outlook, Word, Excel and Power Point.

Competencies

• Adaptability
• Attendance/Punctuality
• Business Acumen
• Computer Skills
• Conflict Management
• Change Management
• Decision Making
• Dependability
• Judgment
• Leadership
• Managing People
• Motivation
• Oral Communication