KBI Biopharma

KBI Biopharma

Manufacturing Specialist I/II, Upstream

USA - NC - Durham - Hamlin Rd · Mid

Sponsorship not specifiedDetected 31 days ago
Customer SupportGMPCell CultureAnimal StudiesMicrosoft OfficeFermentation

About the role

  • Drafting, routing, and revision of manufacturing batch records, procedures, supporting records.
  • First line of defense for manufacturing events.
  • The candidate will assess the event and provide immediate corrective actions.

Responsibilities

  • Manufacturing laboratory equipment: work order initiation and follow up, assessments to support deviations, troubleshooting and vendor coordination.
  • Support activities associated with Operational Excellence Initiatives including Error Proofing, Standardization, 5S, Lean Manufacturing.
  • Responsible for leading technical support activities for GMP Manufacturing Operations in a multi-product, large scale, biopharmaceutical facility.
  • Support safety initiatives, compliance & quality 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.
  • MS Office Software, Electronic Document Management Systems, E-mail

Requirements

  • Knowledge, Skills, Abilities
  • Specialist I: High School Diploma with 5+ years' related industry experience (fermentation, cell culture, purification)
  • Specialist II: High School Diploma with 8+ years' related industry experience (fermentation, cell culture, purification)
  • 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.

Nice to have

  • 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.
  • 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.

Compensation

  • KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching, and employee recognition programs.

Benefits

  • KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching, and employee recognition programs.
  • 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.

Company info

  • At KBI Biopharma, we are advancing science and accelerating breakthroughs.
  • As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster.
  • Explore your potential at KBI, where innovation meets impact.
  • KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies.
  • KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products.
  • Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe.
  • For more information, visit www.kbibiopharma.com.
  • KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce.
  • We believe that innovation thrives in an environment where all voices are heard and valued.
  • That's why we actively seek individuals from all backgrounds - regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status - and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team.
  • KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force.
  • 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.
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This listing is sourced directly from KBI Biopharma's careers page and normalized into a canonical job model.