Position Summary:

The Analytical and Formulation Sciences (AFS) unit of the KBI Commercial Manufacturing Site executes various analytical activities in support of commercial manufacturing, release, and stability. The Project Leader will supervise the daily aspects within the project as well as define activities and manage meeting deliverables internally and externally. The Project Leader must follow all company policies and procedures as well as abide by the instructions described in other controlled documents (e.g. sample plans, ATMs, and forms). Additionally, the candidate must ensure all work conducted by the team members is done in accordance with current Good Manufacturing Practices (cGMP).

Position Responsibilities:

• Responsible for team leader duties of a commercial manufacturing program, including, but not limited to, coordination of intra-team and inter-team efforts; acting as spokesperson, interacting positively and productively with clients; advising upper management on program status
• Provide technical support of product testing for commercial manufacturing, including establishment of methods at CMF (as needed) and review of required materials (including, but not limited to, TSPs, test methods, specifications, testing packets)
• Responsible for producing high quality documentation, client reports, etc., suitable for publication and regulatory requirements.
• Maintain broad knowledge of state-of-the-art principles and theory; provides technical leadership in the group; serves as in-house advisor on key scientific discipline areas.
• Responsible for the management and professional development of lower level Scientists, Associates, and In-Process Support members; orient new employees as to the organization and department policies, and what is expected of them. Review their position responsibilities with them. Communicate and administer procedures for the area in accordance with approved policies.
• Participate in organization, supply maintenance, and recordkeeping duties as needed to support the laboratory
• Periodically analyze the workload and the staffing needs of the department; recommend increases or decreases to staff; prepare position documentation for new and/or modified positions; identify and define qualifications required for new and/or modified positions; interview candidates for opening and make hiring recommendations.
• Adheres to all safety requirements and assures that team employees do the same

Minimum Requirements:

• PhD and 2+ years' directly related experience; or M.S. and 7+ years' of related experience; or B.S. and 10+ years' experience; prior experience must include management experience.
• 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.

Salary: $105,000 - $120,000

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.