The Director of CMC Project Management will be responsible for the creation and execution of multiple complex CMC development and pharmaceutical operations plans. The Director will lead a team of project managers and will work closely with subject matter experts in chemical and formulation development, analytical development, technical operations and supply chain. Director will be responsible for comprehensive communication, including status reporting, risk management and escalation of issues to cross-functional stakeholders and Senior Management. Director will create processes to streamline project management and be accountable for project development and timelines for pharmaceutical development and pharmaceutical operations team members. The Director will become a Go-To person for the team, providing input on content, advice, and leveraging his or her in-depth experience of CMC projects.

Required Skills

• Independently lead sub-teams.

• Work closely with Senior Management and project teams to develop goals, execution plans, budgets.

• Represent CMC on multiple cross-functional teams.

• Regularly interact with the following functions: Chemical Development, Formulation Development, Analytical Development, Technical Operations, Supply Chain, Regulatory, Quality, Clinical Operations.

• Conduct scenario planning and provide analysis and recommendations on development plans and periodically present to management to ensure alignment.

• Based on CMC strategy, (1) prepare and maintain detailed project timelines, (2) track the status of all ongoing development and manufacturing activities and regularly present project status updates, (3) ensure cross-functional alignment within the organization and with global partners

• Develop strong understanding of our strategy, pipeline and capabilities, and actively leverage this knowledge to inform priorities for activities

• Maintain detailed project documentation for knowledge management. Provide document support as needed.

• Manage, develop, and mentor direct reports

Required Experience

BASIC QUALIFICATIONS:

• B.S. and 8+ years of pharmaceutical development, operations or CMC project management experience

OR

• M.S.
• 6+ years pharmaceutical development, operations or CMC project management experience

OR

• Ph.D.
• 3+ years pharmaceutical development, operations or CMC project management experience

PREFERRED QUALIFICATIONS:

• Degree in organic, inorganic, analytical chemistry, biochemistry, chemical engineering
• Excellent communication skills, both verbal and written.
• Experience mentoring team members
• Working knowledge of ICH guidelines, module 3 sections, preparation of investigational new drug applications. Participation of new drug application preparation is a plus.

Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialization of therapeutics for people with kidney disease. The company was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com.

Akebia Therapeutics is an equal opportunity employer and welcomes all job applicants.  All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

AGENCY AND THIRD PARTY RECRUITER NOTICE:

Agencies that submit a resume to Akebia for any position posted on our career page must have a current Akebia agency agreement executed by a member of the Human Resource Department. In addition, agencies may only submit candidates to positions for which they have been invited to do so by an Akebia Recruiter. All resumes submitted outside of these terms will not be considered.

• Independently lead sub-teams.

• Work closely with Senior Management and project teams to develop goals, execution plans, budgets.

• Represent CMC on multiple cross-functional teams.

• Regularly interact with the following functions: Chemical Development, Formulation Development, Analytical Development, Technical Operations, Supply Chain, Regulatory, Quality, Clinical Operations.

• Conduct scenario planning and provide analysis and recommendations on development plans and periodically present to management to ensure alignment.

• Based on CMC strategy, (1) prepare and maintain detailed project timelines, (2) track the status of all ongoing development and manufacturing activities and regularly present project status updates, (3) ensure cross-functional alignment within the organization and with global partners

• Develop strong understanding of our strategy, pipeline and capabilities, and actively leverage this knowledge to inform priorities for activities

• Maintain detailed project documentation for knowledge management. Provide document support as needed.

• Manage, develop, and mentor direct reports