Manufacturing Specialist I/II

Job Summary

Responsible for leading technical support activities for GMP Manufacturing Operations in a multi-product, large scale biopharmaceutical facility. This role will support, but not limited to the following:

• Drafting, routing, and revision of manufacturing batch records, support records, and standard procedures.
• First line of defense for manufacturing events. Individual will assess, provide, and help implement immediate corrective and preventative actions
• Provide manufacturing process support during on-going shop floor execution as needed
• Support new equipment enrollment workflow from purchasing to qualification as needed
• SME support on critical laboratory equipment supporting manufacturing operations. Additionally, SME will lead and manage all activities and event related to critical laboratory equipment
• Support safety initiatives, compliance, and quality requirements.

Responsibilities:

• Generation of batch records, solution records, equipment preparation records, processing assembly records, test sampling plans and process flow charts for specific manufacturing process units.
• Manufacturing laboratory equipment: work order initiation and follow up, assessments to support deviations, troubleshooting and vendor coordination.
• CAPA and Change Control implementations, Safety Improvement implementations.
• Manufacturing operation executions.
• Support activities associated with Operational Excellence Initiatives including: Error Proofing, tandardization, 5S, Lean Manufacturing

Education / Experience Requirements

• Specialist I: High School Diploma with 5+ years' related industry experience (fermentation, cell culture, purification); Bachelor's Degree in a related scientific or engineering discipline preferred with 2+ years' related industry experience; Master's degree in a related scientific or engineering discipline preferred with 0+ year's related industry experience.
• Specialist II: High School Diploma with 8+ years' related industry experience (fermentation, cell culture, purification); Bachelor's Degree in a related scientific or engineering discipline preferred with 4+ years' related industry experience; Master's degree in a related scientific or engineering discipline preferred with 2+ year's related industry experience.

Requirements:

• Ability to read and interpret English documents such as safety rules, operating and maintenance instructions, procedure manuals, batch and production records.
• Ability to write routine GMP documents. Ability to speak effectively on front of internal groups.
• 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 bar graphs.
• Ability to use MS Office Software, Electronic Document Management Systems, E-mail, office equipment, Biosafety Cabinets, Incubators, Single Use Bioreactors, Chromatography columns/skids, Ultrafiltration systems, drug substance filling operations, Peristaltic Pumps and Other Single Use pumps, Automated Cell Counters, Blood Gas Analyzers, Metabolite Analyzers, Scales and Balances, pH
• and Osmolality meters, Other lab equipment, and other production equipment

Range:

• Manufacturing Specialist I: $63,000.00 / yr - $86,900.00 / yr
• Manufacturing Specialist II: $74,000.00 / yr - $102,300.00 / yr

KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

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.