Group Leader / Scientist II

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.

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.

Benefits

• 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.

Schedule

The schedule is flexible and may vary based on project demands.

Pay

Salary Range: $101,000 - $138,600 Salary provided per current averages and expectations.

Qualifications

Salary provided per current averages and expectations.

Skills

Knowledge of cGMPs and biotechnology-derived product regulations.

Contact Information

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force.