Manager, Cold Chain Logistics and Good Distribution PracticesLocation Novato, California Workstyle Open to Hybrid Apply
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. Come join our team and make a meaningful impact on patients’ lives.
This position reports into the Sr. Manager of Supply Chain Global Logistics and independently contributes to keyBioMarin cold chain logistics,global transportand Good Distribution Practices (GDP)processes/activities including, thermal packaging system qualification,transport lane management, transport quality systems, and transport/GDP program improvement initiatives. This role involves working across BioMarin’s global distribution network with internal cross-functional/cross-site groups as well as external supply chain partners.
- Support Implementation of thermal packaging systems, including assessments and qualifications
- Conduct thermal packaging system and transport lane risk assessments
- Own/lead root cause investigations and CAPAs for GMP/GDP environment
- KPIs/metrics management; perform global trend analysis
- Own change control records and perform logistics/cold chain assessments
- Lead implementation for thermal packaging system solutions
- Support temperature excursion evaluation of shipments
- Lead global implementation oflogistics and GDP program improvement project
- Other duties as assigned
Minimum requirement of 5+ years of industry experience and 2years in a similar role.
Required skills needed to accomplish the responsibilities/essential functions include:
- Knowledge of thermal packaging systems
- Experience in qualification/validation processes
- Investigations/Root Cause Analysis skills
- Experience in managing change control
- Skill in data analysis and trending
- Oral and written communication skills
- Technical writing skills
- Team collaboration skills
- Time management skills
Desired skills to accomplish the responsibilities/essential functions include:
Skilled at complex problem solving
- Skilled at influence and negotiation
- Skilled at continuous improvement
- Skilled at risk management
- Presentation skills
Minimum of a bachelor’s degree in supply chain management, life sciences, engineering or equivalent.
- Experience in pharmaceutical industry
- Strong background in global Good Manufacturing Practices (GMPs)/Good Distribution Practices(GDPs) and/or Quality
- Quality Systems knowledge
- Supply Chain
- Global/site logistics planners
- Global Trade Compliance
- Site warehouse
- Quality Assurance, Qualified Persons, Responsible Persons
- Corporate GXP Compliance
- Transportation Service Providers
- Contract Manufacturing Organization
This position has no direct reports.
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.