KBI: US - Associate Scientist

KBI Biopharma • Durham, NC

20h • Onsite

About The Position

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).

Requirements

• 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.
• Strong communication and organizational skills.

Nice To Haves

• Experience in chromatographic, electrophoretic, and immunoassay analytical techniques are preferred.
• 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level