Contract Manufacturing Manager

Responsibilities Manufacturing operations: Develop and lead robust business processes, maintain reliable relationships with contract site management; assess industry trends, internal network, and technology advancements as tools to improve contract site performance. Manage budget development, monitoring, and reporting; create and manage contracts - confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc.; monitor and improve financials with CMO; actively manage and communicate forecasts to the sites and manage capacity planning. Drive operational excellence and champion change.

Site performance monitoring: Manage contract site performance using lean tools and PDCA, lead site operating review meetings; drive improvements at contract sites; sustain and improve the overall health of the business, and lead communication/relationship with the contract site as well as internal management.

Project Management and Technology transfer: Lead a department-wide project from conception to implementation and close-out. Present to and obtain buy-in for value proposition of such projects to senior management. Provide oversight of all planning and coordination of product transfer activities to the contract site(s); develop, present, and obtain approval of budget, timeline and ensure execution of transfer team activities to achieve seamless product transfer to the contract site(s); ensure risk management initiatives are taking place as per RM plan; lead site issue management and resolution; provide issue escalation to executive management.

Preferred Qualifications:

• Bachelor's 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

• Ability to travel +/- 20% of time (domestic and international)

Competencies

• Assimilates multiple inputs and allocates resources to potentially conflicting priorities

• Anticipates and resolves complex problems and integrates into continuous improvement

• Establishes and manages business budget

• Strong influence and negotiation skills

• Expertise in problem solving and risk-based decision-making

• Demonstrated matrix management and organisationally savvy

• Promotes and drives organisational change

• Excellent project management skills

• Mastery of contractual requirements

• Demonstrated ability to lead effectively in collaborative/team environment

• Demonstrated ability to take initiative, drive action, and works independently