KBI Biopharma

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Web Site:
Headquarters:PO Box 15579
1101 Hamlin Road
Durham, NC 27704
United States
Industry:Biotechnology

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KBI Biopharma Jobs

Manufacturing Specialist #581

KBI Biopharma

Location: North Carolina Job Description: Lead activities associated with production process and equipment ownership including: Batch Record Generation, Process Improvements, Training, CAPA Ownership and Implementation, Equipment Upgrades and Maintenance Scheduling, work

12/6/2016  Durham, NC  Save This Job

Research Associate/Sr. Research Associate (Temp Only) #211

KBI Biopharma

Location: Colorado Job Description: Conducts laboratory experiments in support of process development including preparing solutions, running upstream and/or downstream unit operations (fermentation, chromatography, filtration, etc.), and executing basic analysis of process

12/6/2016  Boulder, CO  Save This Job

Quality Systems Specialist #575

KBI Biopharma

Location: North Carolina Job Description: Perform administrative duties for quality computer systems, document and troubleshoot system issues, and provide technical and end user support to ensure efficient and trouble-free operation of quality computer systems; work independently

12/6/2016  Durham, NC  Save This Job

In-Process Support Associate (temp to hire) #579

KBI Biopharma

Location: North Carolina Job Description: Execute activities according to cGMP regulations and company SOPs. Provide STAT assay coverage including 2nd shift and weekends as required by the manufacturing schedule. Assays include A280 and RP titer. Log samples or verify sample log

12/6/2016  Durham, NC  Save This Job

Principal Process Engineer #244

KBI Biopharma

Location: Colorado Job Description: Develop and maintain process models and process flow diagrams for active processes in development. Participate on cross functional process teams, providing input on process design, process economics, facility fit and implementation feasibility

12/6/2016  Boulder, CO  Save This Job

QA Specialist-Quality Engineer #573

KBI Biopharma

Location: North Carolina Job Description: Performs on-the-floor inspections as a QA representative. Provides compliance support to manufacturing operators during critical manufacturing operations (at minimum). Works with the manufacturing group to resolve compliance

12/6/2016  Durham, NC  Save This Job

Research Associate (Temp Only) #228

KBI Biopharma

Location: Colorado Job Description: Conducts laboratory experiments in support of process development including preparing solutions, running upstream and/or downstream unit operations (fermentation, chromatography, filtration, etc.), and executing basic analysis of process

12/6/2016  Boulder, CO  Save This Job

QA Specialist I-Batch Record Review #572

KBI Biopharma

Location: North Carolina Job Description: Performs compliance review on the following records: batch record/formulation record (includes on-the-floor review of records); release and stability data, method qualification/validation reports, stability protocols and development

12/6/2016  Durham, NC  Save This Job

Senior Process Engineer #245

KBI Biopharma

Location: Colorado Job Description: Develop and maintain process models and process flow diagrams for active processes in development. Participate on cross functional process teams, providing input on process design, process economics, facility fit and implementation feasibility

12/6/2016  Boulder, CO  Save This Job

Process Development Assistant/Associate-Downstream (temp to hire) #583

KBI Biopharma

Location: North Carolina Job Description: Buffer preparation for Pilot Plant studies. Management of inventory. Calibrate and maintain laboratory equipment. Document all activities according to the appropriate laboratory procedure and/or KBI Standard Operating Procedure. Freezer

12/6/2016  Durham, NC  Save This Job

Sr. Scientist-Process Development #236

KBI Biopharma

Location: Colorado Job Description: Lead fermentation based process development projects through laboratory activities, documentation, and project milestones. Direct and lead administrative duties of projects including the coordination of team members, client interactions

12/6/2016  Boulder, CO  Save This Job

IT Computer Systems Validation Specialist #576

KBI Biopharma

Location: North Carolina Job Description: Perform administrative duties for analytical systems within the laboratories, document and troubleshoot system issues, and provide technical and end user support. Assist in the configuration and validation of new systems; create and

12/6/2016  Durham, NC  Save This Job

Maintenance Technician II/III (Night Shift) #243

KBI Biopharma

Location: Colorado Job Description: Must have strong mechanical aptitude to support maintenance of specialized production equipment, plant utilities, and HVAC systems in accordance with established guidelines and Standard Operating Procedures. Troubleshoot and repair facilities,

12/6/2016  Boulder, CO  Save This Job

Program Manager #577

KBI Biopharma

Location: North Carolina Job Description: Develop, manage, update and communicate project status, progress, timelines, changes in schedule, scope changes, technical and/or quality issues to all relevant personnel in the company and with the client. Serve as primary liaison to

12/6/2016  Durham, NC  Save This Job

Manufacturing Associate-Upstream #568

KBI Biopharma

Location: North Carolina Job Description: Assist in execution of procedures for cell culture manufacturing, purification, or support area of manufacturing using SOP?s and batch records. Responsible for various duties that are required to produce product including but not limited

12/6/2016  Durham, NC  Save This Job

Associate Engineer/Engineer, Manufacturing Sciences #560/561

KBI Biopharma

Location: North Carolina Job Description: The successful candidate will be motivated to apply scientific and engineering principles in support of new biopharmaceutical process enrollments into the cGMP manufacturing facility. The candidate will perform the following job

11/6/2016  Durham, NC  Save This Job

Sr. Engineer, Manufacturing Sciences-Upstream #562

KBI Biopharma

Location: North Carolina Job Description: The successful candidate will apply scientific and engineering principles to successfully enroll new biopharmaceutical processes into the cGMP manufacturing facility. The scope of this role includes: Acting as the technical transfer lead

11/6/2016  Durham, NC  Save This Job

Manufacturing Associate I #216

KBI Biopharma

Location: Colorado Job Description: Assist in execution of procedures for microbial manufacturing, purification, or support area of manufacturing using SOP?s and batch records. Use equipment and techniques related to support for microbial fermentation and/or harvest and

11/6/2016  Boulder, CO  Save This Job

EM/Microbiology Associate (Temp Only) #235

KBI Biopharma

Location: Colorado Job Description: Performs microbiological in-process and release testing in support of GMP manufacturing. Tests include, but are not limited to, bioburden, microbial purity and endotoxin. Execute environmental monitoring within all classified manufacturing

11/6/2016  Boulder, CO  Save This Job

Facilities Engineering Coordinator #204

KBI Biopharma

Location: Colorado Job Description: Coordinate routine and corrective work with the manufacturing operations Scheduler/Planner to support work within a GMP manufacturing environment. Manage work order work flow within ?Blue Mountain? KBI?s computerized maintenance management

11/6/2016  Boulder, CO  Save This Job

Specialist-Technical Operations #221

KBI Biopharma

Location: Colorado Job Description: Provide technical writing and investigation support for manufacturing deviation reports. Support review of batch documentation to enable batch release milestones to be met. Provide technical and operational support in the writing and execution

11/6/2016  Boulder, CO  Save This Job

QA Specialist II #195

KBI Biopharma

Location: Colorado Job Description: Performs compliance review on the following records: batch record/formulation record (includes on-the-floor review of records); release and stability data, method qualification/validation reports, stability protocols and development

11/6/2016  Boulder, CO  Save This Job

Proposal Development Specialist #539

KBI Biopharma

Location: North Carolina Job Description: Review client RFP?s and participate in client teleconferences to identify and clarify scope of work and deliverables for the preparation of clear and technically detailed proposals. Write, revise, and edit proposal drafts, including

11/6/2016  Durham, NC  Save This Job

Product Specialist #201

KBI Biopharma

Location: Colorado Job Description: Author, review, approve procedures. Includes leading others to accomplish the project deliverables. Develop program related strategy and documents, including policies, project plans and SOPs. Provide technical and operational support for change

11/6/2016  Boulder, CO  Save This Job

Sr. Engineer, Manufacturing Sciences #559

KBI Biopharma

Location: North Carolina Job Description: The successful candidate will apply scientific and engineering principles to successfully enroll new biopharmaceutical processes into the cGMP manufacturing facility. The scope of this role includes: Acting as the technical transfer lead

11/6/2016  Durham, NC  Save This Job

Scientist I, Biopharmaceutical Development #554/558

KBI Biopharma

Location: North Carolina Job Description: Apply biophysical, biochemical and biopharmaceutical principles and techniques to develop protein formulations (liquid or lyophilized). Experience with LC-MS/MSMS analysis of peptides and proteins. Hands-on experience with

11/6/2016  Durham, NC  Save This Job

Research Associate/Sr. Research Associate (Temp Only) #210/211

KBI Biopharma

Location: Colorado Job Description: Conducts laboratory experiments in support of process development including preparing solutions, running upstream and/or downstream unit operations (fermentation, chromatography, filtration, etc.), and executing basic analysis of process

11/6/2016  Boulder, CO  Save This Job

Program Manager #223

KBI Biopharma

Location: Colorado Job Description: Develop, manage, update and communicate project status, progress, timelines, changes in schedule, scope changes, technical and/or quality issues to all relevant personnel in the company and with the client. Serve as primary liaison to

11/6/2016  Boulder, CO  Save This Job

Project Leader/Group Leader, Biopharmaceutical Development #557

KBI Biopharma

Location: North Carolina Job Description: Leading or supporting analytical and formulation development programs to ensure proper integration of all project components for meeting sponsor timelines. Developing study protocols and experimental designs emerging protein drug

11/6/2016  Durham, NC  Save This Job

Director, Process Engineering #226

KBI Biopharma

Location: Colorado Job Description: Responsibility for the direction / oversight of all upstream and/or downstream development activities in all programs/projects and proposals requiring Process Development support. Core competencies and responsibilities include: Manage

11/6/2016  Boulder, CO  Save This Job

Scientist I/II (Temp Only) #212

KBI Biopharma

Location: Colorado Job Description: Executes process characterization, technology transfer to commercial cGMP facility, and process performance qualification activities. Responsible for producing high quality documentation and client reports suitable for publication and

11/6/2016  Boulder, CO  Save This Job

Research Associate (Temp Only) #231/232

KBI Biopharma

Location: Colorado Job Description: Conducts laboratory experiments in support of process development including preparing solutions, running upstream and/or downstream unit operations (fermentation, chromatography, filtration, etc.), and executing basic analysis of process

11/6/2016  Durham, NC  Save This Job

Software Developer #540

KBI Biopharma

Location: North Carolina Job Description: Responsible for the development and management of software (full lifecycle development including specs, writing code, testing, fixing errors/bugs, and 3rd party integrations), specifically related to these high-impact initiatives: Client

11/6/2016  Durham, NC  Save This Job

Specialist-Technical Writer #202/225

KBI Biopharma

Location: Colorado Job Description: Provide technical writing and investigation support for manufacturing deviation reports. Support review of batch documentation to enable batch release milestones to be met. Provide technical and operational support in the writing and execution

11/6/2016  Boulder, CO  Save This Job

Training Coordinator #224

KBI Biopharma

Location: Colorado Job Description: Assist with training activities including, but not limited to: scheduling , coordinating, presenting, employee training; maintaining job position curriculum, filing paper-based training records. Logging/trending/reporting employee

11/6/2016  Boulder, CO  Save This Job

Director, Process Development-Downstream #510

KBI Biopharma

Location: North Carolina Job Description: Fully responsibility for the direction / oversight of all upstream and downstream development activities. Fully responsibility for the direction of all process development and scale-up activities; provide protocol development and

11/6/2016  Durham, NC  Save This Job

Maintenance Technician II #191

KBI Biopharma

Location: Colorado Job Description: Provides day to day Maintenance/Facility functions including: Must have strong mechanical aptitude to support maintenance of specialized production equipment, plant utilities, and HVAC systems in accordance with established guidelines and

11/6/2016  Boulder, CO  Save This Job