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):

Quality Assurance Specialist, Product Support

Scientist, Analytical

Scientist, Purification Process Development

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

Quality Assurance Specialist, Product Support

Employee will be part of a Quality Assurance Product Support team in a contract development and manufacturing setting, and will be the point of contact with Quality representatives from the client team. Employee will also be part of the internal project team working on the client's project. He/She will be responsible for Quality support of the client's project during early stage development and through clinical development. Specific responsibilities include; working with the client QA group and internal colleagues on the client project from start up to completion, review and approval of development reports, test methods, master batch records and product specifications, test data, certificates of analysis, completed batch records, coordinating activities with Document Control and supporting client regulatory inspections. The successful candidate should have strong communication skills, solid skills in working as part of a team and be a good negotiator. Previous experience in supporting audits and regulatory inspections is preferred.

Responsibilities include:

•Performing 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 reports.

•Works directly with manufacturing, the laboratory and other departments responsible for GMP activities to resolve deviations and other compliance issues in a timely manner.

•Monitors training compliance and conducts quality-related training.

•Conducts internal audits of departments involved in GMP activities and provides guidance for corrective actions.

Requirements:

•BS and 8+ years experience or MS and 5+ years or PhD and 0+ years experience in a QA or GMP environment or equivalent. Inter- and intra-departmental project management experience and experience with electronic document management systems desired.

Scientist, Analytical

We are seeking an experienced Scientist in the Analytical group to perform contract development services. These services include Analytical, and Process Development 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:

•Initiating, directing and executing analytical activities for product development programs.

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

•Development, validation and transfer of analytical methods for HPLC, Mass Spec, carbohydrate analysis and immunoassays.

•Biophysical characterization techniques on proteins.

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

•Maintaining a current understanding of FDA regulations.

•Conduct data analysis and trending for multiple projects.

•Source raw materials and equipment with awareness of copendial increases in efficiency of operation.

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

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

•Present selected papers at conferences, identify potential inventions arising from work, and participate in the development of patent applications.

•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.

Scientist, Purification Process Development

KBI Biopharma, Inc. is a contract services organization committed to reducing process development time, decreasing production cost and increasing speed of development for biopharmaceuticals. We are seeking an experienced 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 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.