Manager / Sr. Manager – Genentech – South San Francisco, CA, USA
Thisposition supports the establishment of a world-class packaging organization by leadingan engineering team to develop and deploy new packaging systems for temperaturecontrolled pharmaceutical and combination products. The position is within the DistributionTechnology function of Global Packaging Development (gPKD). Responsibilities include customer service, stakeholderalignment, resource management, staff development, and delivering completedprojects. The selected candidate will beaccountable for delivering packaging solutions that meet quality, business, andenvironmental goals. This position willplay a key role in representing Distribution Technology with globalstakeholders in Quality, Regulatory, Operations, Supply Chain and TechnicalDevelopment Teams. This position will bebased in either SSF or Basel.
Ensure integration of DistributionTechnology with Roche network through understanding customer needs andleveraging the gPKD organization to provide solutions.
Manage engineering lifecycle for global shipping methods.
Support global teams inachieving business, quality and regulatory goals.
Develop and qualify shippingmethods for temperature sensitive products. Scope includes: Drug Substance and DrugProduct, Clinical and Commercial,including CMOsDangerous goods
Determines how to useresources to meet schedules and goals.
Provides guidance to team and delegates assignments based onorganizational goals and established company policies.
Recommends revisions tocurrent policies and/or drives establishment of new policies which effect areaof responsibility.
Manages a team working on avariety of routine and complex initiatives.
Makes independent decisionswithin guidelines.
Makes recommendations tomanagement on matters relating to human resources and department operations.
Frequent interaction withinternal senior level management and outside representatives concerningbusiness unit operations, scheduling of projects or contracts.
Conducts briefings andtechnical meetings for internal and external representatives.
Accomplishes resultsthrough junior supervisors, exempt and/or non-exempt staff.
Responsible for staffingand development of direct reports.
Coordinate and leadquarterly business reviews with senior management and key stakeholders.
Implement strategicpolicies when selecting methods, techniques and evaluation criteria forobtaining long and short term results.
Act as a catalyst andprimary contact for distribution technology functional areas across globaloperating units ensuring team dynamics are collaborative.
Design, qualify andimplementation of new shippingmethods and technologies.
Review and approveengineering lifecycle documents in a GMP environment.
Familiar with emerginginternational regulatory trends in drug and device distribution.
Author shipping validationsection of regulatory submissions.
Understand industry bestpractices in engineering temperature controlled shipping methods
Technical risk assessment,e.g. FMEA for shipping methods.
Thorough understanding ofOSHA and hazardous/dangerous goods regulations and practices (DOT, IATA, ICAO andIMDG).
Provide technical supportto key stakeholders including operations, regulatory and quality.
Maintain strong departmentpresence in network by supporting technical development teams, product supplychain teams, Roche internal and external committees and working groups
Strong collaboration andalignment with multiple stakeholders within and outside the organization.
Lead multi-group and/ordivisional strategic initiatives and projects, oversee and monitor distributionbusiness performance, identify and pursue global cost reduction/continuousimprovement programs.
Leadership of broad networkinitiatives
Routinely solicit andprovide candid feedback.
Alignment of activitieswith other gPKD initiatives.Transfer packaging solutionsinto distribution centers and commercial facilities.
Conducts meetings regardingbusiness unit operations with staff members and management
Cultivate a culture ofexcellent customer service.
Drive towards optimizationand standardization of packaging components.
Demonstrate leadershipthrough representation and/or presenting at conferences, publishing andparticipation in meetings between industry and health authorities.
Who We Are
At Roche, 88,500 people across 150 countries are pushing back the frontiers of healthcare.
Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity. A member of
the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 35 years,
using human genetic information to develop novel medicines for serious and life-threatening diseases. The
headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on
the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech,
where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.
Who You Are
Bachelor degree or higherin materials science, mechanical, chemical or packaging engineering
8-15 years experience inrelevant field.
3-5 years in a supervisoryrole.
Knowledge of temperaturecontrolled shipping processes and test methods.
Understanding of packagingtest methods for parenteral and solid oral dosage drugs will be an asset.
Knowledge of cold chainindustry standards, regulations and best practices.
Excellent leadership, collaborationand communication skills.
Proficient in MS OfficeSuite including MS Project.
English languageproficiency required, knowledge of German an asset.