|
|
|
|
|
|
|
|
|
|
|
|
Biogen Idec
Associate Director, Supply Chain Quality- Small Molecule
Location: Cambridge,
Massachusetts
02142
Posted on:
9/21/2009 10:29:28 AM
Postion type:
Full time
Job Code:
RUSABIO261-700252
Required Education:
Salary:
Salary commensurate with experience
DESCRIPTION
This position requires a dynamic individual who will represent Biogen Idec at contract manufacturing facilities. This individual should have excellent written and verbal communication skills. The scope of this position is to provide quality support for API and solid dosage drug product manufacture for clinical and commercial products manufactured at contract manufacturing organizations in North America. This individual will be responsible for communicating any quality issues to senior management. This individual will participate in cross-functional teams with Planning, Logistics, Contract Manufacturing, Technical Development, Quality Control, Quality Assurance, Regulatory Affairs, and Drug Safety and Risk Management.
Responsibilities include:
Manage the Supply Chain Quality function
Disposition Biogen Idec product manufactured at North American contract manufacturing organizations (CMO), primarily for API and drug product manufacture
Negotiate Quality Agreements with contract manufacturing organizations (CMO) and corporate partners
Provide support for manufacturing deviations and investigations for API, drug product manufacture, shipping excursions, and finished goods distribution
Develop and maintain strong relationships with contractors and corporate partners
Review/approve regulatory submissions prior to agency submission
Participate in BIIB Health Authority audits and support Health Authority audits at contract sites
Approve validation protocols and reports
Lead the Global Contract Manufacturing Operations Management Review meetings
Manage the budget for supply chain quality
Approximately 10-20% domestic travel required.
REQUIREMENTS:
-Minimum of 10 years Small Molecule experience, with at least 5 years experience in Quality Assurance.-Understanding of cGMPs, quality systems and regulations.-Excellent written and verbal communication skills.Minimum of B.S. in Science or Engineering. Advanced degree preferred.
|
|
 |
|
|
|
|
|
|
|
|
|