Scientist II - Analytical Formulation Sciences

KBI is seeking a Scientist II 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 testing and investigations in a GMP laboratory environment.
• Author and review high quality 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 and 3 years’ directly related experience; or M.S. and 7 years of related experience; or B.S. and 10 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: $100,000 - $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.  

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.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

Salary : $100,000 - $110,000