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Associate Director, Analytical Sciences

Akebia Therapeutics

This is a Full-time position in New York, NY posted July 28, 2021.

This is an outstanding leadership opportunity to join a fast-paced company with a robust development and commercial portfolio.

Akebia is seeking a motivated and talented Analytical Chemistry professional to join the Analytical Development team of the Analytical Sciences group.

The successful candidate will lead drug substance and product analytical development from early stages to Phase III.

This individual will report to the Director of Analytical Sciences, supervise Analytical Development scientists, and work with cross-functional teams and external partners to lead analytical chemistry projects.

The position will be responsible for developing analytical controls strategy and overseeing activities at contract development and manufacturing organizations in North America, Europe and Asia.

Required Skills Provide analytical oversight of external vendors for preclinical and Phase I
– III CMC activities for small molecule drug substance (DS) and drug product (DP).

Provide oversight and direction for phase appropriate development, validation and transfer of analytical methods for raw materials, in-process control samples, DS, and DP at CMOs.

Oversee impurity isolation and characterization at CMOs as part of project lifecycle activities.

Supervise analytical development professionals responsible for DS and DP analytical workflow.

Assist with the development and management of the Analytical Development function budget.

Create or modify Standard Operating Procedures associated with the Analytical Development portfolio.

Participate in the development and revision of product specifications, provide scientific input and critique analytical results.

Participate in the preparation of CMC sections of regulatory submissions along with other functional groups.

Ensure compliance with analytical requirements for CMC regulatory submissions.

Familiarity with a broad range of analytical techniques for characterization of pharmaceuticals including thermal methods, HPLC & GC with a variety of detection methods, wet chemical analysis (e.g., KF, dissolution, etc.), spectroscopic techniques, particle size, and heavy metal analysis.

Understand the DS and DP development process and their impact on analytical method development, validation strategies and specifications.

Participate in analytical investigations for deviations/OOS/OOT and ensure proper corrective actions are taken.

Excellent problem-solving skills are required.

Performs other duties as assigned.

Required Experience Master’s degree or PhD in Chemistry, Pharmaceutical Chemistry or related discipline required.

Minimum 10 years (with MS) or 7 years (with PhD) of experience in analytical development, technology transfer and oversight of activities at contract development and manufacturing organizations.

Strong analytical, communication, presentation, and writing skills.

Ability to manage priorities and maintain timelines in a fast-paced environment.

Ability to work cross-functionally.

Regulatory and supervisory experience is a plus.

Position can be remote with occasional onsite meeting attendance required.

TRAVEL REQUIREMENTS: willingness to travel up to 15% domestically and internationally to contract development and manufacturing organizations sites.

No relocation available for this role.