About Technical Operations
BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
RESPONSIBILITIES
- Oversight and responsibilities of the end-to-end process for Raw Materials, which is included but not limited to the following:
- Master Cell Bank management
- Forecasting of indirect raw materials for the Novato Site
- Vendor managed inventory
- Direct GMP raw material release
- Miscellaneous support items
- Third Party warehouses
- Develops and executes replenishment strategies; conducts physical inventories and leads cycle counts.
- Reviews for trends
- Actively investigates result discrepancies
- Reports results to stakeholders
- Delegates and verifies the removal of expired raw materials and expired in-process inventory.
- Manages and reports key metrics to drive Inventory cost savings such as scrap reduction, excess and obsolete, expiry, inventory levels, etc
- Complies with, authors, and enforces SOX (Sarbanes-Oxley Act) requirements, cGMP Documentation, Practices and Regulations.
- Ensures accountability of inventory through transaction documentation, process and procedure verification, and system review.
- Leads operational excellence initiatives to optimize business process and procedures/drive cost savings.
- Manages raw material shortage/stock out by minimizing impact and coordinates action plan to ensure continuous supply.
- Coordinates and provides Support for Supplier Change Notifications
- Provides data analysis for production planning
EXPERIENCE Required Skills:
- Must have 3-6 years of experience in a GMP regulated environment.
- Proficiency in data visualization tools such as Power BI and Excel.
- Understanding of ERP/MRP systems and processes (Knowledge of Oracle/SAP is preferred).
- Understanding of cGMP, FDA, and other regulatory requirements related to pharmaceutical manufacturing and inventory management.
- Demonstrated ability to work cross-functionally and partner with other functional groups to achieve business objectives required.
- Skillful application of KPI's and metrics to manage business processes and support strong team performance.
Desired Skills:
- Experience with lean practices and the DMAIC model.
- Proficiency in analyzing data and translating findings into actionable insights.
EDUCATION
- Required Education: Bachelors in Life Science, Business, Operations Management, or Industrial Engineering required. A combination of technical, military, and/or equivalent experience can be used in lieu of degree.
- Preferred Education: APICS certification and/or supply chain education preferred but not required.
- Other continuing education initiatives highly desirable (e.g., Six Sigma, Lean Manufacturing, industry specific coursework).
SHIFT DETAILS
This is a standard Mon-Fri shift. 7-4
HYBRID ROLE
This role requires you to be onsite in Novato, CA two days a week.
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Who We Are
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.