External Manufacturing Manager, Mirus Bio

Biopharma Careers; Alabama; Hybrid; USD 122,000 - 173,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Job summary

Biopharma Careers is seeking an External Manufacturing Manager to lead production planning with manufacturing partners for raw materials and finished goods. The role involves project management for technology transfer and multi-sourcing, and requires strong cross-functional collaboration across Quality, Operations, Product, and Finance.

The position offers flexibility for remote work within the US and travel up to 20%.

Qualifications

• Bachelor of Science degree in Operations Management, Engineering, Supply Chain, or related field.
• 8+ years of experience in operations/production management or related fields.
• 2+ years engaging with contract manufacturing partners.
• Complex production planning experience required.
• Technical project management experience required.
• Experience in highly regulated environments with quality management system oversight.

Responsibilities

• Create, drive, and execute a robust production plan with manufacturing partners.
• Manage Manufacturing Partner relationships, including communications, meetings, and budgets.
• Project Manager for Technology Transfer and Multi-sourcing projects.
• Implement the Mirus Bio strategy with manufacturing partners.
• Coordinate cross-functional connectivity among Quality, Operations, Product, Finance, and Support.
• Collaborate with RUO Production Manager to align product portfolios.

Skills

Operations management

Production management

Tech transfer

Contract manufacturing

Project management

Cross-functional communication

Regulated environments

Education

Bachelor of Science in Operations Management, Engineering, Supply Chain, or related field

Job description

Work Location: Madison, Wisconsin

Shift: No

Department: LS-PS-UJI Operations A

Recruiter: Anthony Johnson

Your Role

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.

Duties & Responsibilities

• External Manufacturing Manager is responsible for 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.
• Manufacturing Partner Relationship Owner is accountable and responsible for 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.
• Project Manager 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. Quarterback of 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.
• Creator of 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.
• Partner with our internal RUO Production Manager to align overlapping Cell and Gene Therapy Product Portfolio products and associated production plans.
• Demonstrate behavior outlined within the Employee Handbook.
• Perform other duties as assigned by Head of Operations.

Who You Are

Minimum Qualifications:

• 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.

Preferred Qualifications:

• 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.

Travel Requirements

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.

Location

This position is preferred to be site based in our Madison, WI location. We are also flexible to consider fully remote status within the US.

Pay Range

Pay Range: $121,900-$172,900

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites.

The Company is an Equal Employment Opportunity employer

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.