About the Job

The Functional Lead provides leadership of all Lab Operations development related aspects of the Distributed and Tissue Life Cycle teams (LCTs). This position is accountable for the success of FMI’s portfolio from concept to commercialization, including feasibility, development projects, product launches, and commercial supply. The incumbent coordinates LCT development activities with Lab Operations, Supply Chain, Client Services, Clinical Bioinformatics, Translational Oncology and Clinical Reporting.

Key Responsibilities

• Primary operations member of the Life Cycle development teams for the portfolio. Represents operations interests in the planning, development, and launch of new products.

• Ensures alignment of LCT and QTOPS goals – and proactively manages conflicts and trade-off decisions when they occur.

• Ensures robust design transfer of scalable assays.

• Drives sourcing strategy and vendor selection.

• Drives effective two-way communication between life cycle teams and functional areas within Operations.

• Assists in development of and assures execution of strategic and operational plans for assigned Life Cycle teams.

• Provides accurate and timely financial / budget information to ensure fact-based portfolio management and resource utilization.

• Oversees the implementation of operations owned activities critical to life cycle initiatives. These activities include but are not limited to launch of new platform and upgrades as well as lifecycle management of on market product.

• Ensures that optimization processes in Operations are continuously pushed forward and implemented.

• Ensures the compliance to regulatory (e.g. GMP) and legal requirements (occupational health and safety as well as protection of the environment) and represents the interests of Operations with internal and external parties.

• Travel up to 30% of the time (dependent on LCT).

• Other duties as assigned.

Qualifications

Basic Qualifications

• Bachelor’s degree in relevant technical field (chemistry, molecular biology, engineering etc.)

• 8+ years related operations experience in a leadership role; Pharmaceutical/Healthcare Industry background

• 3+ years of experience in Next Generation Sequencing

• 3+ years of experience developing, implementing and supporting high complexity

Preferred Qualifications

• MBA or other Post Graduate Degree

• Applied knowledge of product development processes with familiarity in the design control process

• Ability to manage conflict and encourage collaboration, and successfully implement change

• Demonstrated competencies in team leadership, team facilitation, and team member participation

• Demonstrated ability to engage and deliver through indirect staff across many departments, countries, and cultures

• Ability to deliver in a complex global organization

• Strong communication skills (oral and written) with the ability to present at the functional and executive levels

• Understanding of HIPAA and importance of privacy of patient data

• Commitment to FMI values: patients, innovation, collaboration, and passion

#Hybrid