Director CMC Project Management
Company: Akebia Therapeutics Inc.
Posted on: January 10, 2021
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
- 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
- B.S. and 10+ years of pharmaceutical development, operations
and CMC project management experience OR
- 8+ years pharmaceutical development, operations and CMC project
management experience OR
- 5+ years pharmaceutical development, operations and 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.
Keywords: Akebia Therapeutics Inc., Cambridge , Director CMC Project Management, Executive , Cambridge, Massachusetts
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