In-Process Support Associate

NCBioImpact; North Carolina; On-site; USD 26,000 - 36,000; Full time

Job summary

KBI Biopharma is seeking an In-Process Support Associate with a strong protein chemistry background to support in-process analytical testing for drug substances and products. This role will develop expertise in analytical methods, perform data integrity reviews of STAT samples, and contribute to QC testing for release and in-process samples.

The position primarily supports first shift, with occasional night/weekend/holiday coverage as needed.

Qualifications

• BS in scientific discipline or equivalent.
• Experience in QC analysis of proteins, antibodies, peptides, or vaccines is a plus.
• Excellent verbal and written communication skills.
• Experience working in a cGMP environment preferred.

Responsibilities

• Performs testing on in-process or drug substance/product using bio-analytical techniques such as HPLC, UV-Vis, and simple compendial testing.
• Makes detailed observations and carries out elementary data analysis.
• Understands experiments, conducts troubleshooting analysis, and maintains instrumentation knowledge.
• Documentation upkeep and writing of notebooks and worksheets.

Skills

Protein QC analysis

Data analysis

Documentation

Education

BS in scientific discipline

Tools

HPLC

UV-Vis

Job description

Description

At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact.

Position Summary

We are seeking an In-Process Support Associate with strong protein chemistry background to perform cGMP in-process analytical support. These services include in-process and release testing for drug substances manufactured internally.

The In-Process Support Associate will be trained to execute analytical test methods and their corresponding analytical techniques. The In-Process Support Associate will complete data analysis and/or perform data integrity review of STAT samples, which support manufacturing operations. Additionally, when time permits, QC testing will be executed for Release and in-process samples

*This position will primarily work 1st shift hours, but night/weekend/holiday work will sometimes be required. Off-shift coverage is assigned to team members as-needed on a rotating basis.

Position Responsibilities

• Performs testing on in-process or drug substance/drug product using bio-analytical techniques such as (but not limited to) HPLC, UV-Vis and simple compendial testing. Regularly exercises technical discretion in the execution and interpretation of experiments that contribute to project goals


• Makes detailed observations and carries out elementary data analysis


• Understand experiments, conducts troubleshooting analysis, and maintains knowledge of instrumentation


• Documentation (i.e. Notebook and Worksheet) upkeep and writing skills


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


• Assures proper labeling, handling, and storage of all chemicals used in the area, assures proper labeling and disposition of hazardous waste in satellite area; adheres to all safety requirements and follows safety procedures, and attends all required safety and health training, including handling hazardous waste


• Reacts to change productively and handles other essential tasks as assigned

Position Requirements

• BS in scientific discipline or equivalent


• Experience in QC analysis of proteins, antibodies, peptides, or vaccines a plus, but not required


• Excellent verbal and written communication skills.


• Experience working in a cGMP environment preferred.

Pay Range: $19.23/hour - 26.44/hour

Pay range provided per current averages and expectations. The pay rate and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting upon hire and employee recognition programs.

About KBI

KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, www.kbibiopharma.com.

KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds – regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status – and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team.

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.