Manager / Sr. Manager, Global Packaging Development Distribution Technology Grp – Genentech – South San Francisco, CA, USA
This position supports the establishment of a world-class packaging organization by leading an engineering team to develop and deploy new packaging systems for temperature controlled pharmaceutical and combination products. The position is within the Distribution Technology function of Global Packaging Development (gPKD). Responsibilities include customer service, stakeholder alignment, resource management, staff development, and delivering completed projects. The selected candidate will be accountable for delivering packaging solutions that meet quality, business, and environmental goals. This position will play a key role in representing Distribution Technology with global stakeholders in Quality, Regulatory, Operations, Supply Chain and Technical Development Teams. This position will be based in either SSF or Basel.
Group Responsibilities:
- Ensure integration of Distribution Technology with Roche network through understanding customer needs and leveraging the gPKD organization to provide solutions.
- Manage engineering life cycle for global shipping methods.
- Support global teams in achieving business, quality and regulatory goals.
- Develop and qualify shipping methods for temperature sensitive products. Scope includes: Drug Substance and Drug Product, Clinical and Commercial, including CMOsDangerous goods
Management Requirements:
- Determines how to use resources to meet schedules and goals.
- Provides guidance to team and delegates assignments based on organizational goals and established company policies.
- Recommends revisions to current policies and/or drives establishment of new policies which effect area of responsibility.
- Manages a team working on a variety of routine and complex initiatives.
- Makes independent decisions within guidelines.
- Makes recommendations to management on matters relating to human resources and department operations.
- Frequent interaction with internal senior level management and outside representatives concerning business unit operations, scheduling of projects or contracts.
- Conducts briefings and technical meetings for internal and external representatives.
- Accomplishes results through junior supervisors, exempt and/or non-exempt staff.
- Responsible for staffing and development of direct reports.
- Coordinate and lead quarterly business reviews with senior management and key stakeholders.
- Implement strategic policies when selecting methods, techniques and evaluation criteria for obtaining long and short term results.
- Act as a catalyst and primary contact for distribution technology functional areas across global operating units ensuring team dynamics are collaborative.
Technical Requirements:
- Design, qualify and implementation of new shipping methods and technologies.
- Review and approve engineering lifecycle documents in a GMP environment.
- Familiar with emerging international regulatory trends in drug and device distribution.
- Author shipping validation section of regulatory submissions.
- Understand industry best practices in engineering temperature controlled shipping methods
- Technical risk assessment, e.g. FMEA for shipping methods.
- Thorough understanding of OSHA and hazardous/dangerous goods regulations and practices (DOT, IATA, ICAO and IMDG).
- Provide technical support to key stakeholders including operations, regulatory and quality.
Collaborative Requirements:
- Maintain strong department presence in network by supporting technical development teams, product supply chain teams, Roche internal and external committees and working groups
- Strong collaboration and alignment with multiple stakeholders within and outside the organization.
- Lead multi-group and/or divisional strategic initiatives and projects, oversee and monitor distribution business performance, identify and pursue global cost reduction/continuous improvement programs.
- Leadership of broad network initiatives
- Routinely solicit and provide candid feedback.
- Alignment of activities with other gPKD initiatives.Transfer packaging solutions into distribution centers and commercial facilities.
- Conducts meetings regarding business unit operations with staff members and management
- Cultivate a culture of excellent customer service.
- Drive towards optimization and standardization of packaging components.
- Demonstrate leadership through representation and/or presenting at conferences, publishing and participation in meetings between industry and health authorities.
Who You Are
- Bachelor degree or higher in materials science, mechanical, chemical or packaging engineering
- 8-15 years experience in relevant field.
- 3-5 years in a supervisory role.
- Knowledge of temperature controlled shipping processes and test methods.
- Understanding of packaging test methods for parenteral and solid oral dosage drugs will be an asset.
- Knowledge of cold chain industry standards, regulations and best practices.
- Excellent leadership, collaboration and communication skills.
- Proficient in MS Office Suite including MS Project.
- English language proficiency required, knowledge of German an asset.
