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Global Lead for Clinical Production Optimization
3 months ago
At Genentech, we are committed to ensuring that every patient receives the necessary treatment without delay, and that our clinical trials proceed smoothly. Our aim is to establish a flexible Supply Chain that delivers innovative and sustainable clinical supply solutions to meet the needs of our diverse pipeline of biopharmaceuticals.
Opportunity Overview
As a vital member of the Clinical Supply Chain Organization, the Production Optimization function plays a crucial role in guaranteeing that packaging operations produce the required materials for clinical trials efficiently and on schedule, while also managing costs and quality. The team of Global Production Optimization Leads collaborates with various support groups to ensure timely and effective delivery of clinical products. This involves leveraging study, product, and process knowledge to facilitate seamless processing from initial supply setup to depot receipt. Key responsibilities include making informed decisions regarding kit designs, booklet selection, system setup, and material availability to ensure smooth order management, timely production, finished goods release, and delivery in compliance with local standards and regulatory requirements.
Key Responsibilities:
- Act as the primary liaison with the planning organization for product requirements.
- Facilitate the introduction of new molecules and oversee existing ones, initiating work center activities within the Production Optimization team.
- Ensure kit design feasibility by collaborating with stakeholders such as Planning, Manufacturing, Packaging, Device Development, and Global IMP QA.
- Guarantee the availability of materials to support study timelines, driving on-time and complete production.
- Select appropriate booklet or single panel labels for new packaging materials.
- Conduct impact assessments for new projects affecting various functions, including capacity, technology, and shipping requirements.
- Lead decision-making processes and resolve issues impacting the end-to-end order lead time from source to delivery.
Candidate Profile:
Essential Qualifications:
- Minimum of 5 years of experience in a GMP environment (pharmaceutical or food industry) or equivalent supply chain roles.
- Proficiency in ERP systems, such as SAP, OMP, or APO.
- Experience in project management within cross-functional and multicultural settings.
- Knowledge of production efficiency methodologies, including 5S, Lean Manufacturing, and Six Sigma.
- Demonstrated leadership capabilities in dynamic environments.
- Academic degree or equivalent diploma in Business (Economics, Operations Management, Supply Chain Management), Life Sciences, Engineering, or related fields.
Preferred Qualifications:
- Master's degree in Business (Economics, Operations Management, Supply Chain Management), Life Sciences, or Engineering.
- APICS and/or SCOR certification or relevant experience.
Genentech is an equal opportunity employer, embracing diversity in our workforce. We prohibit unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status, and veteran status.