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: $80,000-$100,000Salary 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
