Scientist II - Group Lead

Position Summary:

Responsible for managing teams and projects within the Analytical and Formulation Sciences (AFS) group, executing development programs for protein biologics.

Position Responsibilities:

• Lead product development from client introduction to commercial production.
• Drive the lifecycle of analytical methods, including development, qualification, validation/verification and transfer both internally and externally.
• Conceptualize and deliver formulations for bulk intermediates, drug substances and drug products across multiple programs.
• Conceive the approach to support QC testing in a cGMP environment, including scheduling across multiple departments to facilitate stability and release testing.
• Lead the project team through development programs that include direction and administrative duties, coordinating the efforts of team members in AFS and other departments, acting as a positive and productive spokesperson on development within the company and to clients, and providing countenance and updates to internal management.
• Write, review and approve high quality documentation, client reports, etc. suitable for publication and in-line with regulatory requirements.
• Maintain knowledge of state-of-the-art principles and theory; providing technical leadership in the group and beyond. Serve as an in-house advisor on key areas of scientific discipline.
• Provide technical support for clinical manufacturing and product testing.
• Identify potential inventions arising from work and the development of patent applications.
• Manage the professional development of scientists and associates; orienting new employees and providing clear direction to meet department goals. Communicate and administer procedures in accordance with approved policies.
• Evaluate workload and communicate the staffing needs of the department; preparing job descriptions for new and/or modified positions including the identification of qualifications required. Interview candidates for openings and make hiring recommendations.

Job Requirements:

• Ph.D. and 5+ years directly related experience, MS with 8+ years of directly related experience, or a B.S. and 12 years related experience.
• 5 Years experience in a relevant managerial capacity.
• Deep and broad knowledge of cGMP requirements and product regulations.
• Technical expertise and depth in developing and troubleshooting UPLC, HPLC, CE, gel electrophoresis, qPCR, and ELISA assays.
• A minimum of 2 years administrative and project leadership required, effective line management and the direction of an operational group preferred.
• Demonstrated track record in the following key areas:
• Quality and Customer Service and deep respect for individuals.
• Strong contribution to science in the appropriate area.
• High level of integrity and personal responsibility.
• Record of innovation.
• History or collaboration and team building skills.

Salary: $108,000 - $148,500

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.