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

Scientist I-Mass Spectrometry

KBI Biopharma

Location: North Carolina Job Description: Perform LC-UV/MS and LC-MS/MS analysis of peptides and proteins. Apply advanced Waters LC-MS systems to analyze native and processed therapeutic proteins using both intact- and peptide-level approaches. Support LC-MS characterization

6/28/2016  Durham, NC  Save This Job

Sr. IT Validation Specialist #180

KBI Biopharma

Location: Boulder, Colorado Job Description: Own / manage the KBI Boulder IT Validation Master plan for all computer systems. Align site validation plans with Corporate IT validation requirements. Manage the execution and documentation of the site IT Validation Program assuring

6/28/2016  Boulder, CO  Save This Job

Process Development Scientist I #490

KBI Biopharma

Location: North Carolina Job Description: Supports product development efforts in the process and manufacturing areas. Conceptualizes and proposes process development and manufacturing based on biopharmaceutical data. Responsible for producing high quality documentation and

6/28/2016  Durham, NC  Save This Job

Manufacturing Support Associate (temp to hire) #507

KBI Biopharma

Location: North Carolina Job Description: Maintain Manufacturing facilities by routine/non-routine cleanings. (Daily, Weekly and Monthly Cleanings.) Requires gowning qualifications. Assist with preparation of solutions, including weigh outs of components, mixing/counting of

6/28/2016  Durham, NC  Save This Job

Sr. Manufacturing Associate #187

KBI Biopharma

Location: Boulder, Colorado Job Description: Execute manufacturing processes without supervision & provide work direction to less experienced personnel. Act as shift lead when necessary. Must have in-depth knowledge and expertise in area equipment/systems, as well as

6/28/2016  Boulder, CO  Save This Job

Associate Director, Quality Assurance #182

KBI Biopharma

Location: Boulder, Colorado Job Description: Provides direction to a QA department responsible for product release, QA on the floor in manufacturing, review and resolution of deviations, QA Materials review, and QA review of QC testing. Lead, assess, coach, and develop

6/28/2016  Boulder, CO  Save This Job

Microbiology Associate (temp) (Part Time) #179

KBI Biopharma

Location: Boulder, 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

6/28/2016  Boulder, CO  Save This Job

Process Development Principal Scientist #489

KBI Biopharma

Location: North Carolina Job Description: Supports product development efforts in the process and manufacturing areas. Conceptualizes and proposes process development and manufacturing based on bio-pharmaceutic data. Responsible for producing high quality documentation and

6/28/2016  Durham, NC  Save This Job

Scientist I #506

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

6/28/2016  Durham, NC  Save This Job

Manufacturing Manager #188

KBI Biopharma

Location: Boulder, Colorado Job Requirements: Execute manufacturing requirements by meeting or exceeding productivity, quality and capacity objectives as set forth by management. Manage daily schedules of production activities, outline staff assignments, material and equipment

6/28/2016  Boulder, CO  Save This Job

Director, Computer Systems Validation #509

KBI Biopharma

Location: North Carolina Job Description: Own I manage the KBI corporate Validation Master Plan for all computer systems. Manage the execution and documentation of the corporate CSV Program . This includes management of life cycle of process from protocol, corporate alignment ,

6/28/2016  Durham, NC  Save This Job

Senior Director, Regulatory #503

KBI Biopharma

Location: North Carolina Job Description: Lead CMC writing and review for Sponsors, utilize internal resources as needed to draft, review and edit CMC sections of Sponsor?s filings. Provide overall direction to Regulatory department that is responsible for CMC support, regulatory

6/28/2016  Durham, NC  Save This Job

Research Associate/Sr. Research Associate #505

KBI Biopharma

Location: North Carolina Job Description: Regularly exercises technical discretion in the execution and interpretation of experiments that contribute to project goals. Makes detailed observations and carries out elementary data analysis. Understands experiments and conducts

6/28/2016  Durham, NC  Save This Job

QA Specialist #183

KBI Biopharma

Location: Boulder, Colorado Job Description: Performs compliance review on the following records: batch record (includes on-the-floor review of records); release data. Reviews and approves Master Batch Records and Solution Records. Works directly with manufacturing, the

6/28/2016  Boulder, CO  Save This Job

Research Associate-Analytical Development (temp)

KBI Biopharma

Location: North Carolina Job Description: Capable of performing bio-analytical techniques such as HPLC/UPLC, SDS-PAGE, Western Blot, Plate-based assays (ELISA, etc) with minimum training and under supervision. Prior hands-on experience or knowledge with HPLC, SDS-PAGE, and

6/28/2016  Durham, NC  Save This Job

Microbiology Associate (temp) #178

KBI Biopharma

Location: Boulder, 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

6/28/2016  Boulder, CO  Save This Job

Material Handler (temp) #181

KBI Biopharma

Location: Boulder, Colorado Job Description: Maintain shelf life and lot controls for Durham Stockroom, keeping accurate inventory levels and performing year end physical counts. Count and safeguard all material entering the plant and prepare necessary documentation. Immediately

6/28/2016  Boulder, CO  Save This Job

Microbiology Manager #171

KBI Biopharma

Location: Boulder, Colorado Job Description: GMP Utilities Testing and Monitoring. Environmental Monitoring. In-process and Final Product Testing. Water Chemistry Analysis. Disinfectant Effectiveness Program. Growth Promotion of Media. Inventory and Management of Laboratory

5/29/2016  Boulder, CO  Save This Job

Sr. Validation Engineer #498

KBI Biopharma

Location: North Carolina Job Description: Coordinate and execute validation studies, writing proposals, documenting results, and generate final reports and summaries of work for release of equipment tested. Develop and revise new and existing procedures to insure compliance to

5/29/2016  Durham, NC  Save This Job

Director, Process Development #152

KBI Biopharma

Location: Boulder, Colorado Job Description: Fully responsibility for the direction of all process development and scale-up activities; provide protocol development and execution support. Execute development and manufacturing requirements by meeting or exceeding productivity,

5/29/2016  Boulder, CO  Save This Job

Sr. Manufacturing Associate I-Upstream #500

KBI Biopharma

Location: North Carolina Job Description: Execute manufacturing processes without supervision & provide work direction to less experienced personnel. Act as shift lead when necessary. Must have in-depth knowledge and expertise in area equipment/systems, as well as independently

5/29/2016  Durham, NC  Save This Job

Sr. Manufacturing Supervisor-Upstream #491

KBI Biopharma

Location: North Carolina Job Description: Execute manufacturing requirements by meeting or exceeding productivity, quality and capacity objectives as set forth by management; assist with transfer of processes from ?client? to production facility. Supervise and train permanent and

5/29/2016  Durham, NC  Save This Job

Manufacturing Associate-Upstream #494/495

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

5/29/2016  Durham, NC  Save This Job

Group Leader/Scientist #501

KBI Biopharma

Location: North Carolina Job Description: Leading 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 candidates from

5/29/2016  Durham, NC  Save This Job

Sr. Manufacturing Associate #163

KBI Biopharma

Location: Boulder, 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

5/29/2016  Durham, NC  Save This Job

Manufacturing Associate (Upstream)

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. Use equipment and techniques related to support, mammalian cell culture and/or harvest and

5/29/2016  Durham, NC  Save This Job

Process Development Associate/Sr. Associate-Cell Line Development

KBI Biopharma

Location: North Carolina Job Description: Performs routine cell culture works in the lab including vial thaw, cell freeze, maintenance of mammalian cell culture, transfection, stable pool generation, single cell cloning, high throughput screening, productivity and stability

5/29/2016  Durham, NC  Save This Job

Biotechnology Program Manager #418

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

5/29/2016  Durham, NC  Save This Job

Facilities Technician III #482

KBI Biopharma

Location: North Carolina Job Description: Perform corrective and preventative maintenance of architectural systems, structural/civil systems, mechanical systems, electrical systems, plumbing systems, process equipment and utility equipment training on and following approved

5/29/2016  Durham, NC  Save This Job

Microbiology/ES Associate #132

KBI Biopharma

Location: Boulder, 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

5/29/2016  Boulder, CO  Save This Job

Scientist I #165

KBI Biopharma

Location: Boulder, Colorado 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

5/29/2016  Boulder, CO  Save This Job

In-Process Support Associate (Temp to Hire) #166

KBI Biopharma

Location: Boulder, Colorado Responsibilities: 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

5/29/2016  Boulder, CO  Save This Job

Accounts Payable Clerk

KBI Biopharma

Location: North Carolina Job Description: Prepares accounts payable vouchers by matching invoices, receiving reports and purchase orders. Uses the company?s chart of accounts to code invoices to proper accounts and departments. Enters invoices into automated accounting

5/29/2016  Durham, NC  Save This Job

Manufacturing Supervisor-Upstream #499

KBI Biopharma

Location: North Carolina Job Description: Execute manufacturing requirements by meeting or exceeding productivity, quality and capacity objectives as set forth by management; assist with transfer of processes from ?client? to production facility. Supervise and train permanent and

5/29/2016  Durham, NC  Save This Job

Store Room Inventory Clerk (Temp to Hire)

KBI Biopharma

Location: North Carolina Job Description: Responsible for the oversight of the Storeroom material consumption. Responsible for identifying the current issues with the SalesPad scanners, documenting and communicating the errors that the users are encountering to the Supervisor

5/29/2016  Durham, NC  Save This Job

Batch Record Review Writer-Upstream

KBI Biopharma

Location: North Carolina Job Description: Perform rewrites/updates/further improvement including edits of documents as a result of feedback from review teams. When necessary mentor other technical writers and team members. Work independently and collaboratively with multiple

5/29/2016  Durham, NC  Save This Job

Sr. Financial Analyst #466

KBI Biopharma

Location: North Carolina Job Description: Prepares and analyzes consolidated reporting at all levels of the organization on actuals, forecasts and prior fiscal year. Manages, in partnership with the company?s corporate and regional cost center owners, the corporate G & A (general

5/29/2016  Durham, NC  Save This Job

Associate Director, Quality Assurance #169

KBI Biopharma

Location: Boulder, Colorado Job Description: Provides overall direction to a QA department responsible for product release, QA on the floor in manufacturing, review and resolution of deviations, QA Materials review, and QA review of QC and stability testing. Emphasis also placed

5/29/2016  Boulder, CO  Save This Job

Senior Project Manager, Engineering #168

KBI Biopharma

Location: Boulder, Colorado Job Description: Manage activities associated with the planning, design, construction and implementation of new manufacturing systems including process facilities and equipment in a cost effective, timely manner. Provides multi-disciplinary technical

5/29/2016  Boulder, CO  Save This Job

Manufacturing/Technical Operations Specialist (temp) #175/176

KBI Biopharma

Location: Boulder, Colorado Job Description: Provide technical writing support for Batch Production Records, Solution Production Records, Standard Operating Procedures. Provide technical writing and investigation support for manufacturing deviation reports. Support review of

5/29/2016  Boulder, CO  Save This Job

Non-Conformance CAPA Investigator #497

KBI Biopharma

Location: North Carolina Job Description: As part of each investigation, gathers information from all necessary internal and external sources in order to evaluate the impact of the deviation on manufactured product, as well as the risk to future operations. The investigator will

5/29/2016  Durham, NC  Save This Job

Microbiology Specialist # 170

KBI Biopharma

Location: Boulder, Colorado Job Description: GMP Utilities Testing and Monitoring. Environmental Monitoring. In-process and Final Product Testing. Water Chemistry Analysis. Aseptic Gowning Program. Disinfectant Effectiveness Program. Growth Promotion of Media. Inventory and

5/29/2016  Boulder, CO  Save This Job

Data Reviewer/Sr. Research Associate/Scientist #383

KBI Biopharma

Location: North Carolina Job Description: Perform timely review of cGMP data from HPLC, ELISA, CE, etc. with a high focus on data quality and integrity to ensure accuracy, completeness, and compliance. Verify that calculations and documented information are present, complete and

5/29/2016  Durham, NC  Save This Job

Accounting Supervisor #465

KBI Biopharma

Location: North Carolina Job Description: Recommend, develop and monitor compliance of accounting policies and procedures related to areas of responsibility. Support Controller with monthly financial close process and concurrently perform multiple assignments and special projects

5/29/2016  Durham, NC  Save This Job

Calibration Technician II #136

KBI Biopharma

Location: Boulder, Colorado Job Description: Perform calibration to instrumentation that includes but is not limited to temperature, flow, pressure, weight indicators, and measurement Standards within a GMP manufacturing environment. This will require performing work in

5/29/2016  Boulder, CO  Save This Job

Downstream Engineer, Manufacturing Sciences

KBI Biopharma

Location: North Carolina Job Description: The successful candidate will apply scientific and engineering principles to support new biopharmaceutical process enrollments into the cGMP manufacturing facility. The candidate will: Collaborate with process development and

5/29/2016  Durham, NC  Save This Job