Please note this position is located in Andover, MA and is apart of a career laddter; all levels of experience are encouraged to apply.
The Senior Manager, CMC is responsible for the oversight of CMC projects. This role provides program direction and manages timelines across internal functional and organizational lines as well as with external clients.
Oversee the CMO’s analytical laboratories to solve CMC issues for ORA clients.
Provide necessary program direction for planning, organizing, developing and integrating project across multiple functional areas
Effectively build project teams as necessary
Create and maintain detailed project plans to ensure clarity of deliverables and timing
Provide feedback to management of project progress/scope changes/new business opportunities
Cultivate effective communication, cooperation and trust with clients
Interface with FDA division personnel to present pre-IND and IND packages.
REQUIRED SKILLS AND ATTRIBUTES:
The ability to solve problems is critical.
Previous experience solving formulation/analytical/ manufacturing issues in ophthalmic biotech/pharma organizations.
Prior task management experience with proven record for effective cost and schedule control of multi-disciplinary technology-based tasks in the pharmaceutical or biotech industry
Minimum of 10 years of scientific technical knowledge (scientific discipline such as chemistry, chemical engineering)
Must be able to understand and interpret analytical
Previous manufacturing/quality operations support experience required.
Experience in moving a product forward is required.
FDA exposure and/or interface is required.
Previous experience creating the CMC section of Pre-IND and IND packaging.
Bachelor’s degree in chemistry or chemical engineering; MS preferred.
Minimum of 5 years of Project Management experience
Personal skills to lead, direct, and motivate personnel
Excellent communication skills, both oral and written
Ability to develop and maintain relationships at all levels within Ora and with Ora’s clients.