Supervisor – Manufacturing Support
| Company | KBI Biopharma |
|---|---|
| Location | Durham, NC, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Mid Level, Senior |
Requirements
- Bachelor’s degree in a related scientific or engineering discipline and 4 years’ experience in related cGMP manufacturing operations; or high school degree and 10 years’ experience, or equivalent.
- 2+ years prior leadership/supervisory experience.
- Excellent written and verbal communication skills are required.
- Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.
- Fluent in reading and writing the English language. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, batch, and production records. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
- Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret graphs.
- MS Office, ERP, EDMS, production equipment software, other
- Upstream or downstream bioprocessing equipment, general production equipment, in-process testing instruments, and office equipment.
Responsibilities
- Plan, schedule, and support daily production tasks to ensure schedule adherence while maintaining a successful and cGMP compliant execution.
- Facilitate additional manufacturing activities and process support with other manufacturing groups, MS&T, PD, QA, Maintenance, Facilities, AFS and Microbiology.
- Ensure timely execution and review of batch documentation and logbooks, initiation of deviations, and execution and completion of ERP orders.
- Ensure timely corrections to batch documentation and logbooks.
- Supervise, coach, mentor, and train team members to maintain educated, qualified, and motivated employees. Ensure staff maintain a high level of compliance to procedures and quality expectations.
- Ensure equipment and manufacturing facilities remain in working order by overseeing maintenance, cleaning, and ensuring timely submission of work orders for facility and equipment maintenance and repair.
- Author, train, review manufacturing procedures
- Drive process improvement initiatives; troubleshoot issues; track and trend metrics; and author, review, and approve manufacturing deviations, CAPAs, and change controls, as needed.
Preferred Qualifications
- Demonstrated knowledge of upstream (cell culture or microbial fermentation) or downstream unit operations for production of biopharmaceuticals is preferred.
- Experience in single-use platform technology is preferred.
- For Supervisor, prior experience in a leadership/supervisory role is preferred.
- Knowledge of quality systems and regulatory expectations is preferred.