Position Summary:
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 Project 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 Project 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 Project 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).
Responsibility
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 management of SPR methods to support early phase and late phase product characterization. Conceptualize and propose method development, method qualification and validation strategies for SPR assays.
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.
Participate in organization, and recordkeeping duties as needed to support the laboratory
Adheres to all safety requirements and assures that team employees do the same
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. The Project Leader/Scientist II- AFS titles reflect increased experience as the title increase in series.
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.
