Contract Manufacturing Senior Manager (Site Lead) - 1 day per month onsite - 12 month contract
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 organizationally savvy
- Promotes and drives organizational 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
