Department
Health & Biotech
Category
Health & Biotech
Job type
Full-Time
Experience
10 Years
Description
- Assemble and lead matrixed cross-functional teams comprised of scientist and engineers responsible for all operational aspects of process development, manufacturing, quality assurance and quality control spanning multiple sites
- Implement site transfers, new indications, new presentations and lifecycle projects for on market programs on time and within budget for Oncology biologics programs
- Proactively identify and drive technical and project plan related issues to closure by working with all relevant functional lines and effectively troubleshooting and driving decisions
- Manage multiple projects concurrently, operating with minimal supervision
- Understand project drivers, requirements, scenarios and options. Proactively drive development of contingency and/or risk mitigation plans.
- Manage competing timelines and make difficult decisions regarding priorities among projects.
- Effectively communicate and present project status to Operations senior management and stakeholders
- Accountable for setting program and project plans, including timelines and expenses, that meet business and organizational objectives and ensuring those plans are achieved.
- Define budget requirements and report monthly actuals, LBE, and Plan/LRP schedules per financial schedule
Qualifications
Highest qualification: University
- 10+ years of combined experience in positions related to process development, project management, engineering/process support and manufacturing
- Must have strong knowledge of GMP Manufacturing, Supply Chain, Validation, Engineering, CMC technical development and pharmaceutical regulations
- Must have demonstrated organizational and planning skills, excellent verbal and written communication skills
- Must have demonstrated strong project management skills with successful delivery of projects
- Must be able to effectively facilitate the resolution of complex scientific, technical, analytical and business issues across functional lines
- Plant experience a must
- PMP certification a plus
- Proficiency in multiple languages a plus