KBI is seeking a Scientist I with a passion for and the motivation to perform analytical testing in partnership with internal and external pharmaceutical clients. The qualifying individual will be a part of the KBI Boulder Analytical Development team in AFS, developing and supporting testing for GMP activities.
Qualified team members will be capable of :
- Develop, troubleshoot, and perform bio-analytical techniques including HPLC / UPLC, CE-SDS, icIEF, SDS-PAGE, Western Blot and plate-based assays (ELISA, etc.)
- Perform QC testing and investigations in a GMP laboratory environment.
- Author and review GMP data, client protocols and reports, method qualification and validation protocols and reports, and GMP documentation suitable for publication and regulatory requirements.
- Provide technical support for clinical manufacturing and product testing.
- Support ongoing efforts to improve efficiency and processes.
- Adhere to all safety requirements and procedures.
A successful candidate strives for continuous improvement, generation of high-quality data / documentation, and proactively addresses observed scientific opportunities.
Job Responsibilities :
Understand microbial protein therapeutic process development and appropriate analytical tools through biochemistry knowledge.Work closely with team members to perform analytical methods to support process development and recommend creative technical problem-solving options.Design and perform development of analytical test methods.Ensure accurate and complete documentation of results via electronic notebook, technical documents, power point, etc.Provide support for the review and approval of analytical test methods, study protocols and technical reports. Provide technical review of GMP data.Prepare technical updates for internal and client review, supporting professional and positive client interaction, maintaining flexibility for change and accelerated timelines.Present data, timelines, and method updates to internal and external teams to inform and support decision making and client feedback.Conceive the approach to support QC testing in a cGMP environment, including communication and planning across multiple departments to facilitate stability and release testing.Provide technical support for clinical manufacturing and product testing.Guide and mentor junior staff in method development, troubleshooting, and GMP testing.Strong desire and demonstrated ability to foster innovation.Minimum Requirements :
PhD; or M.S. and 5 years of related experience; or B.S. and 7 years’ experience; prior experience must include analytical lab testing experience. Quality Control and GMP experience preferred.Excellent written and verbal communication skills are required. Must be organized and able to focus in a fast-paced, multi-tasked environment, and maintain operational efficiency and positive demeanor. Must be able to react to change productively and handle other essential tasks as assigned. Must demonstrate leadership and the ability to collaborate and work with teams.Must have knowledge of cGMPs and biotechnology-derived product regulations.Good critical thinking and scientific skills, with a demonstrated ability to analyze, interpret, and clearly present complex data with conclusions.Salary : $90,000 - 110,000
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, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.
Salary : $90,000 - $110,000
