KBI: US - Associate Scientist

KBI Biopharma; Durham (NC); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Annual bonus structure

Medical, dental, and vision coverage

Paid PTO and holidays

401K matching with vesting

Job summary

KBI Biopharma in Durham, NC, is seeking a highly skilled analytical professional to join the Analytical and Formulation Sciences team. You will perform GMP testing for product release and stability, support analytical method transfer and qualification activities, and review data with strong documentation practices.

The role requires advanced technical writing and presentation skills, with familiarity in cGMP and regulatory expectations.

Qualifications

• Requires Bachelor’s degree in chemistry, biochemistry, or related area with 5+ years of experience or Master’s degree with 3+ years of experience.
• Good oral presentation and technical writing skills are required.
• Records information clearly and consistently per cGMP/GLP/GCP requirements.
• Understanding of biotherapeutic regulatory requirements.
• Experience in chromatographic, electrophoretic, and immunoassay techniques preferred.

Responsibilities

• Execute GMP testing including product release and stability, method transfer and qualification/validation per documents.
• Review and analyze data for experiments performed by self and others.
• Produce high-quality documentation and client reports suitable for publication and regulatory requirements.
• Understand experiments and conduct troubleshooting analysis.
• Maintain current understanding of cGMP and regulatory requirements.
• Stay updated with literature and instrumentation knowledge; adapt to change.
• React to change productively and handle other essential tasks as assigned.

Skills

GMP testing

Method transfer

Tech writing

Oral presentation

Documentation

Communication

Education

Bachelor’s degree in chemistry/biochemistry

Master’s degree in related field

Tools

HPLC

UPLC

Western blot

SDS-PAGE

CE-SDS

qPCR

ELISA

Job 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:

Join a highly technical analytical team in a dynamic work environment. Participate in contracted client analytical programs as a member of Analytical and Formulation Sciences (AFS) team. Perform testing services including GMP testing, analytical method transfer activities, analytical method qualification\validation activities with a focus on separations technologies (HPLC, UPLC, western blot, SDS-PAGE, CE-SDS). Abilities in other analytical techniques applicable to the business needs are desirable (Biophysical methods, ELISA, qPCR, etc).

Responsibilities:

• Execute testing for GMP testing including product release and stability, analytical method transfer, analytical method qualification\validation activities as instructed by controlled documents.
• Review and analyze data for the experiments performed by self and by other analysts.
• Responsible for producing high quality documentation, client reports, etc. suitable for publication and regulatory requirements.
• Understand experiments and conducts troubleshooting analysis
• Responsible for maintaining a current understanding of cGMP and other regulatory requirements.
• Maintains familiarity with current scientific literature, maintains professional expertise through familiarity with scientific literature. Maintains and updates knowledge of instrumentation.
• React to change productively and handle other essential tasks as assigned.

Requirements:

• Requires Bachelor’s degree in chemistry, biochemistry, or related area (or equivalent training) with 5+ years of experience or Master’s degree with 3+ years of experience. Able to react to change productively and handle other essential tasks as assigned. Good oral presentation and technical writing skills are required.
• Records (accurately, clearly, and consistently) information, facts, and measurements that are required by cGMP, GLP, GCP, and/or by co-workers to understand situations and to perform their assignments.
• Understanding of biotherapeutic regulatory requirements and expectations.
• Experience in chromatographic, electrophoretic, and immunoassay analytical techniques are preferred.
• Strong communication and organizational skills.

Salary Range:

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range.

• annual bonus structure for all employees
• medical, dental, and vision coverage
• paid PTO and holidays
• 401K matching with 100% vesting upon hire
• 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, visit 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 is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

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.