• Job Description

  Req#: 202307-117770

  The Position

  JOB SUMMARY

  The Senior Manager of New Product Transfer leads a team of Scientists and Engineers that coordinate with Development, Regulatory and Project teams at Roche to launch new Assays, Reagents and Bulk materials used in tissue diagnostic tests as well as the launch of new diagnostic platforms. This leader, with their team develops and implements operations requirements for design transfer across all product portfolios and collaborates with development, manufacturing and technical support teams to assure that all aspects of design for quality and manufacturability (DQM) are utilized for robust design development, transfer and ultimately scale up. Assures appropriate test method validations and product specifications are developed and implemented. Individual is also responsible for managing new part number creation and appropriate work instruction development. Establishes overall team direction and goals, and sets direction of resources toward completion of goals, in conjunction with Director Assay Transfer and Senior Leadership in both Development and Operations. Promotes an open, collaborative environment focused on teamwork. Aligns on Reagent and Instrument life cycle project timelines in consultation with respective Operations Functional Leads. Establishes and maintains design transfer project milestones and timelines. Supports robust design specification development and validation activities during design transfer, working closely with counterparts in the development team..

  Provides leadership of design transfer activities of products developed by other BA's to RTD OPS. Also engages in technology transfer activities involving product end of life or transfer to other Roche manufacturing site.

  Responsibilities :

  People Development and Leadership (50%)

  • Understand and drive local and global strategic initiatives, and actively provide input and feedback relative to local strategy; Builds Roche network(s) to support and drive local and global initiatives.

  • Leads leaders or complex departments to implement overall departmental structure to ensure stability to meet future needs, assigning responsibilities, delegating, recruiting, selecting, training and retaining employees.

  • Leads and coaches with a “servant leadership” mentality; Applies Roche leadership principles (Visionary, Architect, Coaching and Catalyst) as a standard way of leading and achieving production targets

  • May lead other leaders; Drives and is accountable for team success and results through coaching, counseling, goal setting, managing performance, team building and development, embodying our People Practices, and monitoring and improving KPIs.

  • Visible leader to organization by working with third party vendors, providing tours, delivering presentations to internal and external stakeholders; Active member of the extended leadership team, including engaged participation in daily tiered meetings.

  • Creates vision to inspire and motivate others.

  • Accountable for holding self and peers responsible to a higher standard of performance.

  • Creates an environment that allows others to grow into their potential.

  Quality and Safety, Compliance (20%)

  • Be a role model for Quality, Safety and Compliance

  • Empowered to make proactive changes to ensure we maintain our Right to Operate and that all processes are performed according to procedure

  • Resolve any potentially unsafe hazards and actively drives accountability through organization; Collaborating with other functions to implement resolutions; Trending of safety hazards, incidents and near misses; Creating action plans and implementation of preventative measures.

  • Accountable for compliance and enforcement of Good Manufacturing Practices/Quality System Regulation and Safety guidelines and policies in all areas of responsibility.

  • Reviews, signs-off and ensures staff is trained on documentation, including individuals and team training compliance (e.g. NCRs, OJT, Operating Procedures, Manufacturing Work Instructions, new product transfer, process validation)

  • Responsible for maintaining greater than 95% in training compliance for self and areas of responsibility. Verifies effectiveness and proficiency of training.

  • Audit readiness (OSHA, FDA, Area audits, etc.); Represent operations during internal audits/inspections.

  • Responsible for identification and implementation of root cause, corrective actions, nonconformance reports and CAPA’s in all areas of responsibility.

  Production and Financials (20%)

  • Based on production plan, collaborate with other areas to establish priorities, maximize efficiency of labor, equipment, and materials; Monitor daily/weekly/monthly progress and take appropriate and proactive action to meet commitments; Identifying areas of improvement and capable of leading teams to implement corrective measures in a timely manner.

  • Partners with other area(s) in the development of material replenishment strategies, production quality standards, methods, policies, procedures, equipment and labor needs based on product requirements to meet the organizational goals.

  • Delivers financial objectives by preparing and managing departmental budgets, expenses, analyzing variances, costs, and may prepare capital and other financial justifications; Able to communicate and present financial information to multiple levels of the organization.

  • Responsible for publishing and communicating key performance metrics, analyzing and developing and executing plans for improvement.

  • Partner with senior leadership and other functions to create long term capacity planning for headcount, equipment, and space.

  • Collaborate with peers and other leaders to design and implement departmental, local and global strategies.

  • Demonstrated ability to embrace change and bring creative ideas to complex situations.

  Continuous Improvement (10%)

  • Act as a change agent and drive a culture of continuous improvement by actively demonstrating the use of Agile and Lean Manufacturing tools such as Heijunka, bottleneck analysis, waste identification and elimination, SMED, Kanban, Kaizen and Poka-Yoke in everything the team does

  • Development and execution of lean projects to identify opportunities to reduce costs, improve quality and improve process efficiencies.

  • Develop and implement Leadership Standard Work (LSW) and designing standard work/best practices through their area(s) of responsibility.

  • Conducts regular GEMBA walks with team and peers to actively identify improvements relative to safety, compliance and productivity.

  • Demonstrated pride in the work area/production area through cleanliness, organization, 6S, and elimination of waste

  Travel Requirements

  • Less than 5%, based on business needs

  
  

  Other duties as assigned.

  QUALIFICATIONS

  To perform this job successfully, an individual must be able to perform each responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the responsibilities.
  

  Formal Training/Education

  • Bachelor's Degree (required) - preferred Logistics/Supply Chain, Science, Engineering/Engineering Technology or Life Science discipline

  • Master’s Degree (preferred) with 5 years of relevant work experience, 5 years of direct people leadership experience

  Experience

  • 7 years relevant work experience, preferably in regulated industry

  • 5 years direct people leader experience

  • Six Sigma certification or Green Belt, preferred

  • Experience operating in a GMP/regulated environment, required

  • Experience leading leaders, preferred

  • Demonstrated experience with Lean/Continuous Improvement and/or Agile methodologies

  Are equivalencies acceptable?

  No

  Knowledge, Skills and Abilities

  • Strong organizational and problem-solving skills.

  • Excellent written and oral communication skills.

  • Conceptual knowledge of MRP/ERP systems, digital tools, process workflows and project management is preferred.

  • Strong influencing skills; Consistently achieves targeted results without authority and by leveraging his/her expertise, knowledge, interpersonal skills, organizational savvy and relationships with all levels of staff and management.

  • Ability to professionally interact with all levels of staff and leadership, raise concerns or challenges in a productive and competent manner, and proactively ask provocative questions to challenge assumptions and status quo.

  • Demonstrated ability to develop and lead/direct a high-performing team.

  • Exceptional skills in assessing, summarizing and presenting business or operational priorities and decision-points for effective, timely and efficient management/executive decision-making.

  • Preferred experience in Google suite of products

  • This position may require the individual to wear and work in personal protective equipment.

  • Available for on-call duty for after-hours emergencies. May work extended hours, weekends and/or holidays.

  Relocation assistance is available for this opportunity.

  Who we are

  At Roche, more than 100,000 people across 100 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.

  Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. Our integrated staining, workflow management and digital pathology solutions optimize laboratory efficiency to reduce errors and support diagnosis for pathology professionals. Together with Roche, Ventana is driving personalized healthcare through accelerated drug discovery and companion diagnostics.

  Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

  If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants .

• About the company

  606018 F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics.

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