Research Associate I / II

KBI Biopharma; North Carolina; On-site; USD 60,000 - 85,000; Full time

Job summary

KBI Biopharma, Inc. in Durham, NC seeks a Research Associate to contribute to analytical projects within the Analytical and Formulation Sciences team. You will execute lab experiments, analyze data, and collaborate with cross-functional teams to deliver high-quality results.

Responsibilities include cGMP-compliant testing, HPLC, SDS-CGE, UV-Vis, ELISA, and reporting. Minimum requirements include a chemistry/biochemistry degree and related GMP lab experience; strong data analysis and technical

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, or related field required.
• Experience with protein analytics and analytical methods development in GMP labs preferred.
• Strong data analysis and technical writing skills required.

Responsibilities

• Precisely execute testing according to cGMP principles for biotherapeutic samples and document information per SOPs and study protocols.
• Perform analytical testing using HPLC, SDS-CGE, UV-Vis, ELISA and appearance/compendial methods.
• Analyze data and prepare technical reports and ELN entries per cGMP and Good Documentation Practices.
• Troubleshoot experiments and support method improvements.
• Present findings to internal teams and clients.

Skills

Protein biochemistry

Analytical method development

cGMP knowledge

Data analysis

Technical writing

Team collaboration

Education

Bachelor's degree in Chemistry

Bachelor's degree in Biochemistry

Master's degree (related field)

Tools

HPLC

SDS-PAGE

Capillary electrophoresis

UV-Vis

DSC

CD

FTIR

SPR

qPCR

Job description

We are seeking a motivated and detail-oriented Research Associate to join our Analytical and Formulation Sciences (AFS) team in Durham, NC. This role is ideal for those with experience in protein analytics, analytical methods development and qualification in a GMP laboratory. In this role, you will contribute to client-focused analytical projects by executing laboratory experiments, analyzing data, and collaborating with cross-functional teams to deliver high-quality scientific results.

Responsibilities:

• Precisely execute testing according to cGMP principles for the testing of biotherapeutic samples and able to record (accurately, clearly, and consistently) information, facts, and measurements that are required by cGMP, GLP, GCP, and/or by test method, company standard operating procedures (SOPs) and study protocols.
• Execute experimental protocols and perform testing for analytical techniques such as HPLC, SDS-CGE, UV-Vis, ELISA and appearance and compendial test methods.
• Analyze experimental data and document results in technical reports and electronic lab notebooks in compliance with cGMP according to Good Documentation Practices.
• Troubleshoot experiments and support method improvements.
• Present findings to internal teams and clients.
• Adhere to all safety requirements and ensure that departmental employees comply with required safety procedures. Ensure proper handling, labeling, and disposal of chemicals and hazardous materials.
• Contribute to team-based problem solving and continuous improvement.

Skills & Competencies

• Hands-on laboratory experience with protein biochemistry and separations analytical techniques such as HPLC, SDS-PAGE, capillary electrophoresis, UV-Vis Spectroscopy. Abilities in other analytical and biophysical techniques applicable to the business needs are desirable such as DSC, CD, FTIR, SPR and qPCR.
• Proficiency in scientific software and data analysis tools.
• Strong data analysis and problem-solving skills. Regularly exercises technical discretion in the execution and interpretation of experiments that contribute to project goals.
• Ability to troubleshoot experiments
• Effective technical writing and communication skills
• Ability to work both independently and collaboratively in a fast-paced environment. Able to react to change productively and handle other essential tasks as assigned.

Minimum Requirements:

Research Associate I: Bachelor’s degree in Chemistry, Biochemistry, or related field; 0+ years experience

Research Associate II: Bachelor’s degree with 3+ years experience or Master’s with 0+ years

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, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.