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):

Process Development Scientist/Engineer-Fermentation and Cell Culture

Scientist, Biopharmaceutical Development

Thank you for your interest in one of our open positions at KBI Biopharma, Inc. As part of the application process, please complete the Affirmative Action Invitation to Self ID and submit along with your resume to careers@kbibiopharma.com. Make sure to include the Requistion number and Position Title in the subject line of your email.

KBI Biopharma, 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.

KBI Biopharma

1101 Hamlin Road

Durham, NC 27704

Process Development Scientist/Engineer-Fermentation and Cell Culture

We are seeking an experienced Scientist/Engineer to work in the Fermentation/Cell Culture group to perform development, characterization and manufacturing tasks that will help to advance Phase 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:

•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 required

•Sterile technique experience

•Strong verbal/written communication and computer skills

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

Scientist, Biopharmaceutical Development

We are seeking an experienced scientist, with strong protein chemistry and characterization background, to perform contract development services (note: NOT research work). These services include formulation, and analytical development programs for monoclonal antibodies, recombinant proteins and peptides.

Responsibilities include:

•Initiate, direct and execute analytical activities for product development programs.

•Apply biophysical, biochemical and biopharmaceutical principles and techniques to develop protein formulations (liquid or lyophilized).

•Develop, validate and transfer of analytical methods for HPLC, Mass Spec, carbohydrate analysis and immunoassays.

•Biophysical characterization techniques on proteins.

•Conduct data analysis and trending for multiple projects.

•Produce high quality documentation suitable for publication and regulatory requirements.

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

•Maintain broad knowledge of state of the art principles and theory.

•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 5 years experience in analytical method development or formulations for proteins, antibodies, peptides, or vaccines.

•Excellent verbal and written communication skills.

•Experience working in a cGMP environment preferred.