Contract Manufacturing Senior Manager Job Description
Job Title:
Sr. Manager, Contract Development and Manufacturing
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About This Role
This senior manager position is responsible for leading contract manufacturing site operations, including managing relationships with contract sites, assessing industry trends, and improving financial performance.
Key Responsibilities
* Site Performance Monitoring: Manage contract site performance using lean tools and PDCA, lead site operating review meetings, drive improvements at contract sites, and sustain the overall health of the business.
* Project Management and Technology Transfer: Lead a department-wide project from conception to implementation and close-out, present value proposition to senior management, and obtain buy-in.
* Contract Testing Lab (CTL) Support: Manage laboratory supplier relationships, develop performance metrics, and build strong partnerships with external laboratories to enhance efficiency and program success.
Required Skills and Qualifications
* Bachelor's degree in business administration, engineering, or science-related field.
* 8+ years of experience in protein, API, DS, DP, or packaging manufacturing environment.
* 8+ years in roles requiring knowledge of cGMP principles, FDA, and other regulatory guidelines, and validation principles.
* 5+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products.
* 3+ years of project management experience leading multi-functional and multi-location team.
* 3+ years of experience across ACM or CMQ.