At KBI Biopharma, we bring tomorrow’s medicines to the world today, by accelerating our client’s development programs. In a very real sense, we are making a difference in healthcare, one product at a time.

KBI Biopharma is looking for employees in the following area(s):

Staff Accountant

Utility Maintenance Technician

Associate Scientist, Process Development (Fermentation and Cell Culture)

Associate Scientist, Research (Purification)

To send your resume, please contact us at the following email. Make sure to include the Requistion number and Position Title in the subject line of your email.

KBI Biopharma

1101 Hamlin Road

Durham, NC 27704

Email: careers@kbibiopharma.com

KBI Bioppharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, age, disability or Vietnam veteran status, are strongly encouraged to apply.

Staff Accountant

The Staff Accountant coordinates, administers, and processes all aspects of general ledger accounting. This role participates in developing the overall general ledger environment, including processes and best practices. Responsible for ensuring accurate and timely processing of all transactions, completion of account reconciliations, monthly close process and financial statement reporting, and complying with internal controls within the accounting area.

Responsibilities include:

•Monthly closing of the general ledger within the timeframe established by corporate guidelines.

•Prepare and record general ledger transactions in accordance with GAAP.

•On a timely and routine basis, prepare account reconciliations in sufficient detail to substantiate trial. balance accounts to an external auditor with adequate documentation.

•Prepare audit year end work papers and coordinate with the resort on other audit requests as needed.

•Participate in training and developing new team members; participate in cross-training within the team.

•Act as backup for other team members as needed

Requirements:

•Balance sheet reconciliations.

•Prepaid expense schedule creation and maintenance.

•Fixed assets management and reconciliations, including physical inventory.

•Equipment lease schedule preparation.

•Sales and use tax returns.

•Produce monthly expense analysis and variance reports.

•Strong support to the Controller and external support to auditor

Utility Maintenance Technician

KBI Biopharma, Inc. is presently seeking a seasoned multi-craft Utility Maintenance Technician with strong abilities in HVAC, clean utility, mechanical, electrical, and control systems. Candidate will self perform some tasks and supervise service contractors on others.

The Utility Maintenance Technician has general responsibility for the installation, day-to-day operation, maintenance, repair, and modification of all KBI Biopharma site utility systems. This position is also responsible for repairs, troubleshooting, calibration, and preventative maintenance of associated systems and equipment to include all process utility equipment. The technician will perform his/her work in a manner consistent with that of a cGMP biopharmaceutical environment. The technician must be able to work both independently and as a team member. Considerable independent judgment and initiative is required to solve challenging/complex issues.

Responsibilities include:

•Repair and calibrate using precision measuring instruments, hand and/or power tools, electrical repair or modification tools.

•Troubleshoot and repair facilities, equipment, and/or systems, including mechanical, electrical, pneumatic, or hydraulic circuits (motors, pumps, compressors, boilers, chillers, and water system) using manuals, SOPs, specifications, and other workplace aids.

•Perform basic maintenance of non-critical equipment including, but not limited to, basic lubrication, utilizing oil or grease, plumbing and replacing mechanical parts.

•Prepare documents to include maintenance, quality, production, and other documents/reports as deemed appropriate.

Requirements:

•High School diploma or equivalent, preferably including hands-on or vocational school training, and a minimum of ten (10) years of experience as a general maintenance mechanic in a manufacturing environment, or an equivalent combination of training and experience, OR A.S./A.A. Degree in Mechanical/Utilities Technology, or Licensed Journeyman, with a minimum of five (5) years of work experience in a cGMP pharmaceutical manufacturing environment.

•Extensive industrial experience involving utility systems is desirable to include professional credentialing.

•Must be computer-literate and have full knowledge of PLC's, instrumentation and control.

•Regularly demonstrate effective work planning skills.

•Able to contribute to cross functional teams.

•Experience interpreting mechanical/electrical prints and P&ID's

•Experience troubleshooting PID control loops and instrumentation.

•Extensive industrial experience involving utility systems, with a strong knowledge of USP/WFI, clean steam, and pure steam generation systems, compressors, chillers, potable water systems, building controls, electrical distribution system and HVAC systems.

•Ability to work weekends and holidays as needed.

•Ability to respond to emergencies when needed.

Process Development Associate/Scientist-Fermentation and Cell Culture

KBI Biopharma, Inc. is a leader in contract biopharmaceutical development focused on developing scalable, robust processes that maximize the stability and activity of protein- and peptide-based therapeutics. We are seeking an experienced PD Associate or Scientist to work in the Fermentation/Cell Culture group to perform development, characterization and manufacturing tasks that will help to advance Ph I/II programs for recombinant proteins, monoclonal antibodies, peptides and vaccines

Responsibilities include:

•Selection of clones (productivity, stability)

•Cell line evaluation

•Cell line adaptation (e.g. to serum-free or suspension culture)

•Medium development (animal component free)

•Development of robust and scaleable processes

•Development of nutrient feed strategies to prolong culture life and production

•Optimization of existing processes

•Identification of critical process parameters

•Development of process control strategies

•Process scale-up

•Production at pilot scale for preclinical studies

•Process cost analysis

Requirements:

•BS/MS/Ph.D. in life sciences or related discipline.

•Minimum of 2+ years experience with cell culture/fermentation process development for early phase cGMP production

•Sterile technique experience

•Strong verbal/written communication and computer skills

•Excellent customer service skills and the ability to meet strict client deadlines

Research Associate or Scientist, Purification Process Development

KBI Biopharma, Inc. is a leader in contract biopharmaceutical development focused on developing scalable, robust processes that maximize the stability and activity of protein- and peptide-based therapeutics. We are seeking an experienced Research Associate or Scientist in the Purification Process Development group to perform contract development and manufacturing services. These services include Purification Process Development and Manufacturing programs for monoclonal antibodies, recombinant proteins, peptides and vaccines.

Responsibilities include:

•Initiating, directing and executing purification process development activities for product development and manufacturing programs.

•Managing cost and time constraints in meeting committed targets and schedules.

•Practical and theoretical understanding of process chromatography, clarification techniques, ultrafiltration and nanofiltration.

•Actively participate in the cGMP manufacture of PI/PII clinical supplies.

•Training and development of junior staff on core methods and techniques.

•Maintaining a current understanding of FDA rules and regulations.

•Produce high quality documentation suitable for regulatory requirements.

•Act as spokesperson on development programs and interact positively and productively with clients.

•Advise management on program status.

Requirements:

•BS/MS/Ph.D. in scientific discipline or equivalent with a minimum of 2-5 years experience in purification process development for proteins, antibodies, peptides, or vaccines.

•Excellent verbal and written communication skills.

•Significant experience working in a cGMP environment is required.

•Industrial experience required.