KBI
Manufacturing Specialist I/II, Upstream
USA - NC - Durham - Hamlin Rd · Mid
Sponsorship not specifiedDetected 30 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.
This listing is sourced directly from KBI's careers page and normalized into a canonical job model.