Senior Research Associate

KBI Biopharma, Inc.; Durham (NC); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Annual bonus

Medical coverage

Dental coverage

Vision coverage

Paid PTO and holidays

401K matching

Employee recognition programs

Job summary

KBI Biopharma, Inc. is seeking a skilled scientist to join its Analytical and Formulation Sciences team in Durham, NC. You will perform GMP testing for product release and stability, and contribute to method transfers, qualifications, and validations using HPLC/UPLC and related techniques.

The role requires strong data analysis, documentation, and communication skills, with familiarity in cGMP and regulatory expectations. Join a global CDMO committed to quality and innovation.

Qualifications

• Requires Bachelor’s degree in chemistry, biochemistry, or related area with 4+ years of experience or Master’s degree with 2+ years of experience.
• Strong oral presentation and technical writing skills are required.
• Understanding of biotherapeutic regulatory requirements and expectations.

Responsibilities

• Execute GMP testing including product release and stability.
• Perform analytical method transfer/qualification/validation activities.
• Review and analyze data; prepare high-quality documentation and client reports.
• Maintain instrument knowledge and troubleshoot experiments.
• Ensure compliance with cGMP and regulatory requirements.

Skills

HPLC/UPLC

Western blot

SDS-PAGE

qPCR

Data analysis

Technical writing

gCMP/regulatory awareness

Chromatography

Education

Bachelor’s degree in chemistry/biochemistry or related

Master’s degree (optional)

Tools

Analytical instruments knowledge

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.
• Regularly exercises technical discretion in the execution and interpretation of experiments that contribute to project goals 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.
• Makes detailed observations and carries out elementary data analysis.
• Maintains documentation and writing skills.
• 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 4+ years of experience or Master’s degree with 2+ 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

65,000-85,000 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.

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.

• annual bonus structure for all employees
• medical coverage
• dental coverage
• 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.

At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them.

We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills.

At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged.

If you do not see a position that matches your background, we invite you to return to our site often as positions are updated frequently.

To 3rd Party Search Firms/Employment Agencies

All inquiries must be directed to [e-mail]. Please do not call or email any KBI Biopharma employee about current or future job openings. All resumes submitted by search firms or employment agencies to any employee at KBI Biopharma via-email, telephone, social media or other means will be deemed to be the sole property of KBI Biopharma, unless the firm submitting the resume has previously entered into a written agreement with KBI Biopharma regarding recruitment services and has been approved by Human Resources to work on an open position. KBI Biopharma will not pay any fee or remuneration with respect to candidates without complying with this requirement.