Manager Analytical Development Jobs in Denver, CO

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 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/ScientistIIAFS will supervise the daily aspects within the project as well as define activities and manage meeting deliverables internally and externally.

• 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 plans for project team members 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.
• Perform analytical project team leader duties for development, clinical, and/or commercial programs, including coordination of intra‑team and inter‑team efforts, acting as spokesperson, interacting positively and productively with clients, and advising upper management on program status.
• Produce high‑quality documentation and client reports suitable for publication and regulatory requirements.
• Maintain broad knowledge of state‑of‑the‑art principles and theory; provide technical leadership, serve as in‑house advisor on key scientific discipline areas, and develop/maintain current understanding of cGMP and other regulatory requirements.
• Manage and develop lower‑level Scientists, Associates, and In‑Process Support members; orient new employees to organization policies and expectations.
• Review position responsibilities with team members.
• Communicate and administer procedures for the area in accordance with approved policies.
• Participate in organization, supply maintenance, and record‑keeping duties as needed to support the laboratory.
• Periodically analyze workload and staffing needs; recommend staff changes; prepare position documentation for new or modified positions; identify and define qualifications for new or modified positions; interview candidates and make hiring recommendations.
• Adhere to all safety requirements and ensure team employees do the same.
• Handle other essential tasks as assigned.

• PhD and 3+ years directly related experience, or M.S. and 7+ years, or B.S. and 10+ years; prior experience must include management experience.
• Excellent written and verbal communication skills.
• Organized and able to focus in a fast‑paced, multi‑tasked environment while maintaining operational efficiency and a positive demeanor.
• Ability to react to change productively and handle other essential tasks as assigned.
• Demonstrated leadership and ability to collaborate and work with teams.
• Knowledge of cGMPs and biotechnology‑derived product regulations.

• Salary Range: $101,000 – $138,600.
• Annual bonus structure for all employees.
• Medical, dental, and vision coverage.
• Paid FTO and holidays.
• 401(k) matching with 100% vesting upon hire.
• Employee recognition programs.

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