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Associate Director/ Director, CMC Technical Development

Infinity Pharmaceuticals, Inc.

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Location: Cambridge, MA Posted Date: 4/11/2013 Position Type: Full time Job Code: 1234 Required Education: High school or equivalent

Description

Infinity Pharmaceuticals, Inc. is an innovative pharmaceutical company focused on discovering and developing novel small molecules for treatment of cancer and related conditions. Founded in 2001, the company currently has several drug candidates in multiple clinical trials and is seeking to leverage its strength in small molecule drug technologies to discover, develop, and deliver to patients, first-in-class and best-in-class medicines. Infinity is a small, growing, fully integrated pharmaceutical company with capabilities ranging from discovery to commercialization.

Infinity is looking for a Associate Director/Director responsible for leading and managing external manufacturing operations at Contract Manufacturing Organizations (CMO’s) with an emphasis on late stage process development through commercialization.  The candidate must be a strong leader experienced in technical pharmaceutical development primarily utilizing external Contract Manufacturing Organizations (CMO’s) to leverage and drive internal value.  The candidate must be able to manage and integrate cross functional development disciplines at CMO’s and productively integrate these activities with internal functional disciplines. Responsibilities span late stage drug substance and drug product contract manufacturing operations.

This is an exciting opportunity to make a personal difference in cancer and inflammation drug development and be part of a dynamic team.

Responsibilities:
•Establish a late stage/commercial technical development/operations function which leverages external CMO manufacturing capabilities to support late stage clinical supply leading to potential commercial manufacture.
•Responsible for positioning and preparing external drug substance and drug product CMOs for registration/validation activities and NDA preparation.
•The selected candidate will work as an integrated part of the internal teams to set strategies for execution at external CMO’s.
•Responsible for transitioning robust and sustainable drug substance and drug product processes into commercial manufacturing processes.
•Provide guidance to ensure DS and DP processes are appropriate for anticipated commercial needs and are well-matched with CMO’s equipment/technical capability.
•Responsible for translating and transferring process improvements and solutions for manufacturing issues identified by internal technical teams to external late stage CMOs.
•Responsible for technology transfer and CMO selection for late stage and post-NDA projects and establishing capacity and risk-mitigation plans for DS and DP.
•Represent commercial DS/DP manufacturing on CMC teams.
•The selected candidate will eventually act as the process owner to manage late stage/commercial manufacture as development scientist’s transition to new projects post validation.
•Provide technical support for manufacturing investigations, deviations, and quality assessments.
•Other responsibilities include establishing CMO performance metrics, preparation and negotiation of Master Agreements, Supply Agreements, Work Orders, Project Plans, establishing CMO governance structure and Cost-of Goods analysis.
•Build and foster strong, efficient, cooperative and value-added vendor relationships which leverage internal capabilities. Manage Partner Meetings and Joint Operating Committee governance.
•Work collaboratively with CMC regulatory, quality, formulation development, process development, analytical development, strategic sourcing, supply functions, CMC teams.

Requirements

•Ph.D. in a technically relevant discipline such as Pharmaceutical Sciences or Chemistry.  Alternatively, a M.S. or Ph.D. in Chemical Engineering with a  minimum of 10-12 years of experience in technical development and manufacturing of small molecule products in a pharmaceutical or biotechnology organization.
•Experience with late stage CMC development (Ph 3/NDA) into commercialization is essential.
•Extensive experience with CMO management and technology transfer. The ability to forge strong relationships with CMO’s facilitating transparency and advancement of Infinity’s needs and values.
•Extensive hands on manufacturing plant experience supporting cGMP manufacture of API and/or drug product.
•Solid CMC regulatory and cGMP compliance understanding.  Expected to write and review CMC manufacturing sections of IND’s and NDA’s.
•The ability to work in a highly matrixed, cross functional environment.
•Excellent communication, technical writing sand presentation skills.
•People management experience and strong ability to influence, motivate and mentor.
•Willingness to travel domestically and internationally to CMO’s as needed.
•Title will be commensurate based on experience
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