Manufacturing Specialist I​/II, Upstream

Position Summary

Responsible for leading technical support activities for GMP Manufacturing Operations in a multi-product, large scale, biopharmaceutical facility.

• 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 troubleshooting and oversight.
• Support activities associated with Operational Excellence Initiatives including Error Proofing, Standardization, 5S, Lean Manufacturing.

• 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+ years’ 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+ years’ related industry experience.

• 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.

While performing the duties of this job the employee may be exposed to moving mechanical parts. The employee may be occasionally exposed to caustic chemicals and risk of electrical shock. The noise level in the environment is low to moderate.

• 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 production equipment

• Annual bonus structure for all employees
• Medical, dental, and vision coverage
• Paid PTO and holidays
• 401K matching
• Employee recognition programs

KBI Biopharma, Inc. is an Equal Opportunity/affirmative action employer. We seek to diversify our workforce and actively encourage all qualified candidates, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status, to apply.