External Manufacturing Manager, Mirus Bio

Merck•Madison, WI

2d•Hybrid

About The Position

Mirus Bio has an immediate opening for an External Manufacturing Manager that will use their Operations expertise to boost the connectivity between our Mirus Bio Team and our manufacturing partners. As the External Manufacturing Manager, the primary objective of this role is to create, manage and execute a complex robust production plan that includes the manufacture of both raw materials and finished goods, and to coordinate this plan with our manufacturing partners. This role also includes being the Manufacturing Partner Relationship Owner, interfacing directly with our manufacturing partners in addition to being the Project Manager for critical Technology Transfer and Mult sourcing projects. This role reports to the Head of Operations and works closely with the Head of Strategy, Product, and Business Development, Head of Quality, and their teams to implement the strategy related to our manufacturing partners. We are currently on the lookout for a skilled manufacturing manager to join our passionate team. This role will start as an individual contributor position reporting to the Head of Operations, and this role may have the opportunity to expand to a management position with direct reports. If you are someone who thrives in a collaborative, innovative, and fast-paced environment, join us in shaping the future of our industry and be a part of a team that continues to redefine possibilities. This role works cross-functionally with all departments within Mirus Bio.

Requirements

Bachelor of Science (B.S.) degree in Operations Management, Engineering, Supply Chain, or related field with commensurate work experience.
At least 8 years of experience in operations management, production management, technology transfer project management, operations project management, or similar.
At least 2 years of experience engaging with contract manufacturing partners.
Complex production planning experience is required.
Technical project management experience is required.
Experience working in a highly regulated field with robust quality management system oversight is required.
Ability to travel independently up to 20% of the time, including overnight travel.
Ability to drive a vehicle; Must have current and valid U.S. driver license.

Nice To Haves

Excellent cross-functional communication skills capable of flexing communication to work with all levels in an organization.
Ability to effectively translate operational and manufacturing concepts into user-friendly content suitable for diverse audiences, including laboratory scientists, researchers, sales teams, procurement teams, and quality assurance teams.
Contract negotiation (MSA, CDA, etc.) is preferred.
Project Management and/or Supply Chain training and certification through an accredited program are preferred.

Responsibilities

Creating, driving, and executing a robust production plan for our manufacturing partners, that includes both routine manufacturing and new product introduction manufactures of both raw materials and finished goods. This comprehensive production plan includes all product dynamics such as increasing product shelf lives due to ongoing stability studies, aggressive and shifting demand growth, strategic raw material ordering/stocking, NPI multi-batch requirements, multi-lot derisking, and other product/quality/regulatory requirements of ancillary materials for cell and gene therapy.
Managing and developing robust relationships with our manufacturing partners. This also includes tactical relationship activities such as driving communication, driving efficiencies, managing budget, weekly/monthly meetings, business reviews, MSA Negotiations, etc.
Driving our Technology Transfer Projects and Mult sourcing Projects for final products and raw materials following the requirements outlined in our NPI Product Development Processes and Quality Management System.
Quarterbacking the projects with Mirus Bio Project Core Teams and Manufacturing Partner Core Teams to facilitate the execution and provide subject matter expertise.
Responsible for the operational implementation of the Mirus Bio strategy for our manufacturing partners.
Creating connectivity between Quality, Operations, Product Management, Finance, Support and Commercial Teams by facilitating internal conversations and decisions regarding our externally manufactured products and raw materials, including in venues such as SIOP, Project Steering Committees, etc.
Partnering with our internal RUO Production Manager to align overlapping Cell and Gene Therapy Product Portfolio products and associated production plans.
Demonstrating behavior outlined within the Employee Handbook.
Performing other duties as assigned by Head of Operations.