The Manufacturing Supervisor, Solution Prep leads a team of manufacturing associates to perform both upstream and downstream preparation of solutions and growth media used for processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The individual will plan, assign, and monitor daily tasks to ensure timely “Right First Time” execution and strict compliance with safety and quality regulations, e.g., current Good Manufacturing Practice (cGMP). As needed, the Supervisor may also support core production operations (cell culture or purification), lead teams on projects to author standard operating procedures (SOPs) or batch and solution records; implement corrective and preventive actions (CAPAs); support continuous improvement and other initiatives involving safety, quality, delivery, engagement, & cost in accordance to KBI/JSR business objectives. A proven and qualified supervisor will use knowledge and experience to execute production operations, coach staff, troubleshoot, and continuously improve daily operations and/or manufacturing support operations. The Supervisor will have a working knowledge of bioprocessing equipment. including but not limited to, filters, filter integrity testers, balances, pumps, analytical instruments, and disposable technologies (disposable bags, sterile tubing welders, tubing sealers). The Supervisor will review manufacturing procedures and instruct manufacturing personnel to ensure that manufacturing operations are conducted accurately, safely, and compliantly. The Supervisor will maintain a sense of ownership of the production processes, manufacturing environment and facility. Following task execution, the Supervisor will review executed production documents to ensure accuracy and completeness. It is management’s expectation that supervisors uphold the company’s core competencies and departures from specifications and/or policies are reported according to KBI internal notification processes.

JOB RESPONSIBILITIES

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. 30%
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. 10%

Total: 100%

MINIMUM REQUIREMENTS

• Knowledge, Skills, Abilities Level Minimum Requirement Supervisor 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.

• Demonstrated knowledge of mammalian cell culture (or microbial fermentation) or purification operations for production of biopharmaceuticals is preferred.

• Experience in single-use platform technology is preferred.

• Knowledge of quality systems and regulatory expectations is preferred.

• 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.

• Language Ability 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 andcorrespondence. Ability to speak effectively before groups of customers or employees of organization.

• Reasoning Ability 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.

• Math Ability 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.

• Physical Demands Refer to Essential Physical Functions section

• Computer Skills MS Office, ERP, EDMS, production equipment software, other

• Equipment Use Upstream or downstream bioprocessing equipment, general production equipment, in-process testing instruments, and office equipment.

WORKING CONDITIONS

The job requires working nights, 12-hour shifts (2-2-3 schedule) which include working weekends and holidays and may include working overnight. The job requires working within a cGMP manufacturing biotechnology facility which requires clean room operations. Clean room operations require donning clean room attire when entering clean room areas and maintaining good personal hygiene. While performing the duties of this job the employee regularly utilizes equipment and materials which include mechanical hazards, chemical hazards, electricity hazards, and tripping and falling hazards. The noise level in the environment is moderate to high.

Essential Physical Functions

1. Strength

a. Standing 50 % of time Staff will stand throughout facility to various locations during production activities and within production rooms in order to accomplish production tasks. Walking 25 % of time Staff will walk throughout facility to various locations during production activities and within production rooms in order to accomplish production tasks. Sitting 25 % of time Staff will perform activities such as training, document review, and other computer work, as required.

b. Lifting 50 lbs. Staff will lift and carry 20kg bags of WFI, Buffer and Media within facility, as needed. Carrying 50 lbs. Staff will lift and carry 20kg bags of WFI, Buffer and Media within facility, as needed. Pushing 450 lbs. Staff will push 200kg drums of WFI, Buffer, and Media throughout facility, as needed. Pulling 450 lbs. Staff will push 200kg drums of WFI, Buffer, and Media throughout facility, as needed.

2. Climbing Staff must perform some operations on ladders or step stools. Balancing Staff must perform some operations on ladders or step stools.

3. Stooping Staff must be able to reach underneath production equipment for bioprocess container installation and inspection. Kneeling Crouching Staff must be able to reach underneath production equipment for bioprocess container installation and inspection. Crawling

4. Reaching Staff must be able to reach underneath, over, and within production equipment for bioprocess container installation, inspection and use. Handling

5. Speaking Staff must be fluent in English language. Staff must be able to speak with other staff over radios, cell phones, and within production locations over machine noise. Staff will read production instructions to others and appropriately understand instructions. Hearing Staff must be fluent in English language. Staff must be able to hear other staff over radios, cell phones, and within production locations over machine noise. Staff will listen to other staff during reading of production instructions and appropriately understand instructions.

6. Seeing Staff must be able to read manufacturing procedures and execute production activities.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.