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 - Downstream

Process Development Associate or Scientist - Upstream

Supervisor, Downstream Manufacturing

Laboratory Informatics Specialist

Senior Research Associate

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 - Downstream

We are seeking a downstream process development scientist.

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:

•Ph.D. in Chemical Engineering with a minimum of 5 years experience in protein expression, purification and characterization.

•Excellent verbal and written communication skills.

•Significant experience working in a cGMP environment is required.

•Industrial experience required.

Process Development Associate or Scientist - Upstream

We are seeking an upstream process development associate or scientist.

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:

•Ph.D. Chemical Engineering.

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

•Bioreactor experience

•Sterile technique experience

•Strong verbal/written communication and computer skills

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

Supervisor, Downstream Manufacturing

Coordinate and perform cGMP manufacturing operations for manufactured biopharmaceutical products. Ensure the effective use of material, equipment and personnel while making products at high quality levels.

Responsibilities include:

•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 personnel

•Assist with management of production/operation planning and scheduling

•Troubleshoot and maintain manufacturing equipment

•Author, train review SOPs and Batch Records

•Work off-shift hours as necessary or assigned

Requirements:

•Bachelor’s degree in a related scientific or engineering discipline and 3+ years industry experience (purification); or 5+ years related experience and/or training.

Laboratory Informatics Specialist

Provides hands on support of IT systems deployed in support of laboratory operations including ELN, LIMS, CDS, Instrumental Analysis, Lab Automation, Inventory, Data Management and Archival (SDMS). Proactively partner with employees across labs to understand needs and identify appropriate information technology solutions; work with employees and external vendors to improve lab operations and instrumental data analysis through the selection, implementation, and support of software systems used in our labs.

Responsibilities include:

•Provide direct hands on support and administration of various software platforms that support lab researchers including: Electronic Lab Notebooks; Sample Management; Chemical Inventory; Chromatographic Data Systems; Spectroscopic Data Systems; Laboratory Robotics; Instrumental Data Analysis; Data Management and Archival.

•Assist in implementation projects as a technical resource for software evaluation, development of lab/pilot environments, and development and execution of test plans.

•Develop and maintain system documentation for supported applications, including change control and validation documentation where required.

•Working with Quality and Regulatory, use risk-based approaches to assess compliance impacts and build computer systems validation activities into system implementation and change control activities where necessary.

•Provide desktop and server support for Windows environment.

Requirements:

•Minimum of BS in Computer Science or related degree, with 3-5 years of experience working in an IT organization supporting a GLP/cGMP environment, including computer system qualification and 21 CFR Part 11, with biotechnology focus. Knowledge of multiple programming languages and willingness to learn more is a plus.

•Strong interpersonal and communication skills within IT as well as with scientists.

•Ability to multitask and prioritize among competing demands.

•Experience in vendor management and contract negotiation.

•Experience in biotechnology, pharmaceuticals or life sciences a must.

•Previous experience with Waters MassLynx, Agilent Chemstation, ChemLaunch and OpenLab ECM/CDS and ELN or Waters Empower and NuGenesis would be beneficial.

Senior Research Associate

We are seeking a Senior Research Associate, with protein chemistry background, to perform contract development services. These services include analytical and formulations programs for monoclonal antibodies, recombinant proteins, peptides, and small molecules in a variety of dosage form such as liquids and lyophilized powders and suspensions for injection, topical gels, and other novel delivery systems.

Responsibilities include:

•Conducts laboratory experiments in support of biopharmaceutical development and process development utilizing analytical instrumentation.

•Makes detailed observations and carries out elementary data analysis.

•Understands experiments and conducts troubleshooting analysis.

•Maintains and updates knowledge of instrumentation and maintenance.

•Notebook upkeep and writing skills.

•Maintains familiarity with current scientific literature; maintains professional expertise through familiarity with scientific literature.

•Responsible for developing/maintaining a current understanding of cGMP and other regulatory requirements.

•Prepares draft development reports.

Requirements:

•BS/MS in scientific discipline or equivalent with a minimum of 3 years experience in analytical method development or formulations for proteins, antibodies, peptides

•Excellent verbal and written communication skills;

•Experience working in a cGMP environment preferred.