KBI: US - Associate Scientist

About the Role

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.
• Produce high quality documentation, client reports, etc. suitable for publication and regulatory requirements.
• Understand experiments and conduct troubleshooting analysis.
• Maintain a current understanding of cGMP and other regulatory requirements.
• Maintain familiarity with current scientific literature and professional expertise.
• Maintain and update knowledge of instrumentation.
• React to change productively and handle other essential tasks as assigned.

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.
• Good oral presentation and technical writing skills.
• Records (accurately, clearly, and consistently) information, facts, and measurements required by cGMP, GLP, GCP, and/or by co-workers.
• Understanding of biotherapeutic regulatory requirements and expectations.
• Experience in chromatographic, electrophoretic, and immunoassay analytical techniques preferred.
• Strong communication and organizational skills.

Pay

Salary range: $80,000–$100,000. 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.

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.

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.