Associate Director / Director, Packaging Engineering and Global LabelingLocation Novato, California 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.
The AD/D Packaging Engineering and Global Labeling has responsibility for the design, development, testing, coordination, implementation, and maintenance of secondary and tertiary global packaging solutions for clinical and commercial products. Along with this they also have responsibility for leading and managing the process for development of packaging component artwork through external suppliers and internal partners to ensure artwork is provided when required for packaging operations at all domestic and international packaging manufacturers of BioMarin products.
S/he will also be expected to establish and lead a significant process improvement program to ensure both Packaging Engineering and Artwork processes are scalable to support company growth.
S/he is responsible for managing the workload and performance of direct reports in fulfilling their responsibilities associated with the Packaging Engineering and Artwork processes. S/he is a key member on project teams to deliver high-quality packaging on schedule, which meets customer, business, and regulatory needs.
A high level of initiative, energy, and motivation are key role requirements, as well as excellent leadership and organizational skills and effective collaboration with internal and external stakeholders.
- Ensuring Packaging Engineering and Artwork team are adequately resourced to meet current and future demand
- Leadership of the team by providing clear structure and organization of work as well as development opportunities for team members
- Leadership and management of the design, testing, and implementation of secondary, and tertiary packaging components.
- Track and manage delivery of projects to ensure they meet required timelines (eg. product launch, regulatory filings)
- Establish clear metrics and reporting for Packaging Engineering and Artwork business processes
- Leverage business process improvement resources to deliver streamlined business processes within Packaging Engineering and Artwork
- Act as Packaging team leader for key clinical and/or commercial programs to ensure delivery of successful packaging solutions
- Partner with internal and external packaging teams to identify and implement improvement opportunities regarding package design
- Ensure awareness of future trends, process improvements, and new technologies within the team and communicate and introduce as applicable.
- Ensure up to date and accurate SOPs, work procedures, packaging specifications, package design testing protocols are in place
- Oversee testing of the packaging components and packaging systems.
- Work with and travel to contract sites to jointly develop package systems, batch records, distribution and handling methods, and any activities involved in properly transporting the drug throughout the supply chain.
- Apply knowledge of FDA and ISO requirements related to packaging, ensuring robust package verification and approval.
- Solve technical challenges drawing on a combination of experience, sound judgment, problem-solving skills, engineering first principles, and advanced engineering methods.
- Collaborate with Packaging Operations, Commercial Marketing, Regulatory, and contract artwork design companies to develop and manage all commercial artwork activities for Global markets.
- Oversee the implementation of label changes following regulatory guidance and commercial style guides
- Accountable for ensuring all labeling projects/submissions and implementation deadlines are met from project initiation to delivery of ready to print artwork
- Owner of Artwork Management System
S/he will assist in the establishment of the budget to accomplish project requirements. This includes component materials, testing, consultants, artwork development, print proofs and all other expenses required to meet artwork needs. S/he will assist in determination of capital investment requirements for Short- and Long-Range Planning.
- BS Degree in Business, Graphic Design, or an area related to business- or management-related activities
- Minimum of 5 years managing international artwork development and implementation activities in a GMP environment.
- Demonstrated development, leadership and implementation of process change programs
- Demonstrated ability to organize, structure and lead a large global team (approx. 15 people)
- Proficiency with AMS, Trackwise and with Oracle or other materials management systems is desired. Excellent MS Office, MS Project, and Visio skills.
- Experience with CAPA, FMEA, RCA tools in a highly regulated manufacturing environment preferred.
- Working knowledge of GMPs
- Must have excellent interpersonal, written, verbal, and presentation skills
- Demonstrated project management skills
- Collaboration/Influence Management, Decision Making, Results Orientation
- Ability to work effectively with cross-functional and multi-location teams.
- Successful track record in execution of deliverables. Changes in plans and updates are proactively communicated to management and teams.
- Strong quality orientation with attention to detail
- Excellent organizational, interpersonal communication, and problem-solving skills
- Ability to find, communicate, and implement ways to continuously improve processes
- Strong organizational and leadership skills.
- Process development or technology transfer experience preferred.
- Excellent written, verbal, and presentation communication skills.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.