The Analytical and Formulation Sciences (AFS) unit executes various analytical activities in support of internally and externally manufactured products for both non-GMP and GMP products. Activities include, but not limited to: method development, method establishment, method qualification, method validation, bridging method qualifications, method transfers, compendial method verification, reference material characterization, non-GMP Drug Substance release and stability, non-GMP Drug Product release and stability, reference material release and stability, GMP Bulk Drug Substance release and stability, GMP Drug Product release and stability, Placebo release and stability, IVSS release and stability, clinical in-use studies, preformulation studies, formulation studies, identity testing, and various ad-hoc stand alone tests.

The Group Leader/Scientist II AFS will supervise the daily aspects within the project as well as define activities and manage meeting deliverables internally and externally. The Group Leader must follow all company policies and procedures as well as abide by the instructions described in other controlled documents (e.g., TSPs, ATMs, and forms). Additionally, the Group Leader must ensure all work conducted by the team members is in accordance with current Good Manufacturing Practices (cGMP), if applicable, and Standard Operating Procedures (SOPs).

Position Responsibilities:

• Provide technical support for testing, including method establishment, method qualification, method validation, bridging method qualifications, method transfers, compendial method verification, reference material characterization, non-GMP Drug Substance release and stability, non-GMP Drug Product release and stability, reference material release and stability, GMP Bulk Drug Substance release and stability, GMP Drug Product release and stability, Placebo release and stability, IVSS release and stability, clinical in-use studies, preformulation studies, formulation studies, identity testing, and various ad-hoc stand alone tests.

• Review documentation (method transfer documentation for clients, method qualification documents from Analytical Development, TSPs, and internally generated protocols and reports) and plan for executions. Devise plan for members of the project team to accomplish goals.

• Support product development efforts in the process, formulations, and analytical development areas. Conceptualize and propose process development, formulations development, and analytical development strategies based on biopharmaceutical data.

• Responsible for analytical project team leader duties of development, clinical, and/or commercial programs, 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

• 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; develop/maintain a current understanding of cGMP and other regulatory requirements.

• 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:

Minimum of 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 management experience. T

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 Range: $101,000 - $138,600

Salary 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 different from the provided value. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid FTO and holidays, 401K matching with 100% vesting upon hire and employee recognition programs.