KBI Biopharma
Manufacturing Specialist I/II, Downstream
KBI Biopharma, Durham, North Carolina, United States, 27703
Manufacturing Specialist I/II, Downstream
Join to apply for the
Manufacturing Specialist I/II, Downstream
role at
KBI Biopharma .
Position Summary This position will provide technical support activities for GMP Manufacturing Operations in a multi-product, large‐scale biopharmaceutical facility. The role supports:
Drafting, routing, and revision of manufacturing batch records, procedures, and supporting records.
Manufacturing process support during ongoing shop floor execution, when required.
Support new equipment enrollment efforts from purchasing to qualification activities.
First line of defense for manufacturing events, assessing the event and providing immediate corrective actions.
Lead implementations for corrective and preventive actions.
Point of contact for laboratory equipment supporting manufacturing operations, troubleshooting, vendor calls, equipment repair coordination, operational changes, and system qualifications.
Support safety initiatives, compliance, and quality requirements.
Job 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 support and troubleshooting.
Support activities associated with Operational Excellence Initiatives including error proofing, standardization, 5S, and lean manufacturing.
Job Requirements Knowledge, Skills, Abilities
Specialist I: High School Diploma with 5+ years of related industry experience (Downstream/Purification operations preferred); Bachelor’s Degree in a related scientific or engineering discipline preferred with 2+ years of related industry experience; Master’s degree in a related scientific or engineering discipline preferred with 0+ years of related industry experience.
Specialist II: High School Diploma with 8+ years of related industry experience (Downstream/Purification operations preferred); Bachelor’s Degree in a related scientific or engineering discipline preferred with 4+ years of related industry experience; Master’s degree in a related scientific or engineering discipline preferred with 2+ years of related industry experience.
Language Ability
Read and interpret English documents such as safety rules, operating and maintenance instructions, procedure manuals, batch and production records.
Write routine GMP documents.
Speak effectively in front of internal groups.
Reasoning Ability
Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Math Ability
Add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
Compute rate, ratio, and percent and draw and interpret bar graphs.
Physical Demands
May be exposed to moving mechanical parts.
May be occasionally exposed to caustic chemicals and risk of electrical shock.
Noisy environment: low to moderate noise level.
Computer Skills
Knowledge or prior experience using MS Office Software, Electronic Document Management Systems, and E‑mail.
Equipment Use
Knowledge and experience using equipment such as Office equipment, biosafety cabinets, incubators, single‑use bioreactors, chromatography columns/skids, ultrafiltration systems, drug substance filling operations, peristaltic pumps, and other single‑use pumps.
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, 401(k) matching, and employee recognition programs.
About KBI 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.
KBI is an 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. We actively seek individuals from all backgrounds and encourage qualified candidates 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 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.
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Manufacturing Specialist I/II, Downstream
role at
KBI Biopharma .
Position Summary This position will provide technical support activities for GMP Manufacturing Operations in a multi-product, large‐scale biopharmaceutical facility. The role supports:
Drafting, routing, and revision of manufacturing batch records, procedures, and supporting records.
Manufacturing process support during ongoing shop floor execution, when required.
Support new equipment enrollment efforts from purchasing to qualification activities.
First line of defense for manufacturing events, assessing the event and providing immediate corrective actions.
Lead implementations for corrective and preventive actions.
Point of contact for laboratory equipment supporting manufacturing operations, troubleshooting, vendor calls, equipment repair coordination, operational changes, and system qualifications.
Support safety initiatives, compliance, and quality requirements.
Job 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 support and troubleshooting.
Support activities associated with Operational Excellence Initiatives including error proofing, standardization, 5S, and lean manufacturing.
Job Requirements Knowledge, Skills, Abilities
Specialist I: High School Diploma with 5+ years of related industry experience (Downstream/Purification operations preferred); Bachelor’s Degree in a related scientific or engineering discipline preferred with 2+ years of related industry experience; Master’s degree in a related scientific or engineering discipline preferred with 0+ years of related industry experience.
Specialist II: High School Diploma with 8+ years of related industry experience (Downstream/Purification operations preferred); Bachelor’s Degree in a related scientific or engineering discipline preferred with 4+ years of related industry experience; Master’s degree in a related scientific or engineering discipline preferred with 2+ years of related industry experience.
Language Ability
Read and interpret English documents such as safety rules, operating and maintenance instructions, procedure manuals, batch and production records.
Write routine GMP documents.
Speak effectively in front of internal groups.
Reasoning Ability
Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Math Ability
Add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
Compute rate, ratio, and percent and draw and interpret bar graphs.
Physical Demands
May be exposed to moving mechanical parts.
May be occasionally exposed to caustic chemicals and risk of electrical shock.
Noisy environment: low to moderate noise level.
Computer Skills
Knowledge or prior experience using MS Office Software, Electronic Document Management Systems, and E‑mail.
Equipment Use
Knowledge and experience using equipment such as Office equipment, biosafety cabinets, incubators, single‑use bioreactors, chromatography columns/skids, ultrafiltration systems, drug substance filling operations, peristaltic pumps, and other single‑use pumps.
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, 401(k) matching, and employee recognition programs.
About KBI 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.
KBI is an 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. We actively seek individuals from all backgrounds and encourage qualified candidates 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 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.
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