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
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 10+ years of pharmaceutical development, operations and
CMC project management experience
8+ years pharmaceutical development, operations and CMC project
5+ years pharmaceutical development, operations and CMC project
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.