Job Description
Who We Are 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. SUMMARY DESCRIPTION:The Sr. Manager Product Launch is accountable for planning and coordination of activities to launch products into new markets. The Sr. Manager Product Launch is a matrix leader, responsible for managing the Product Launch Team consisting of colleagues from commercial, regulatory, supply chain, manufacturing and quality. The Sr. Manager Product Launch is a full-time member of one or more Product Supply Chain teams, with accountability to ensure product launches achieve market timing requirements. Sr Manager Product Launch builds integrated plans across Technical Operations, Regulatory and Commercial Operations. Key responsibilities:• Apply project management expertise, methodologies and standards to manage launches and packaging lifecycle changes for multiple product lines• Leverage well developed interpersonal skills to build and maintain positive working relationships with key stakeholders• Develop tools and metrics to use across product lifecycle changes and launches• Develop, maintain track, and manage high quality, integrated project plans to enable accurate reporting and decision making• Ensure team members adhere to established process and project delivery methodology• Manage critical path and key project risks• Prioritize activities effectively across multiple products and launches to ensure best use of time• Challenge status quo with continuous improvement and efficiency in mind. Key interfaces include:• Supply planning• Demand planning• Commercial operations;• Enterprise Master Data Management;• Logistics • GMSAT including packaging engineering and validation;• Regulatory Global Labeling • CMC Regulatory Affairs• Packaging Operations / Supply Chain Operations (Shanbally and GEO)LEADERSHIP RESPONSIBILITY:Sr. Manager Product Launch is a matrix leader, responsible for leading and coordinating cross-functional teams of 10-15 functional leaders or representatives, who are responsible for planning and execution of market level product launches. Sr. Manager Product Launch measures performance to achieve deliverables and provide feedback to functional management. Utilizes the data from performance metrics and feedback to identify and develop solutions for the broader teams to gain long term efficiencies. Sr. Manager Product Launch provides coaching and development to team members on project and launch management methodologies.Must have / Minimum Requirements:• BS/B.Sc., preferably in the life science, engineering, supply chain or business administration• Minimum 4 years of materials management, production planning and scheduling experience• Minimum 4 years GMP/GCP compliant Pharmaceutical operations experience• Minimum 3 years project management experience.• Good understanding of Pharmaceutical industry (regulatory environment, GMP and ICH Guidelines)• Effective ability to educate and lead through influence management, team members and cross-functional peers.• Effective communication (oral, and written)• Ability to operate globally, across different time-zones, work with global and regional functions.• Strong ability to make risk-based decisions and escalate to executive management when appropriate.• Ability to understand the big picture and focus or execute the details to deliver product strategies; strategic thinker with operative capabilities• Ability to understand impact of unique issues from multiple functional perspectives including Regulatory, Quality, Supply Chain, and Manufacturing to assess best options• Business process thinker. Drives for continuous improvement of business process to achieve product strategies.• Provides coaching and manages work activities for projects and teams.• Can accommodate required international travelNice to have:- MBA, preferably in supply chain management, finance or business operations- Lean-DMAIC expertise, preferably Green Belt Certified or higher- Project management certification, PMP or equivalent.- Strong regulatory and GMP acumen- Matrix leadership experience. Experience managing global, multicultural, multi-functional and remote teams in a matrix organization* Team leader responsible for global, cross-functional, teams defining commercialization product development and supply strategy.* Scope includes start of Phase II-b through end of commercialization period when product is transferred to the long term supply organization.* Develop and execute an Integrated Development and Supply Plan, enabling the achievement strategic objectives and tactical development requirements to optimize patient and business outcomes. 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.
