The Global Engineering team is responsible for making technology happen for Genentech and Roche global by transforming the “technology roadmaps” into live solutions. The Global Engineering team is present in 4 locations: Basel, Madrid, Shanghai and South San Francisco, covering all time zones with around 100 highly qualified engineers. The Senior Engineer Security & IAM, NALA Region position is located at the South San Francisco site. The main responsibilities of the position are:

• Design and develop technology solutions, including evaluation of promising technologies and development of evaluation criteria
• Work with vendors, architecture, operations and solution owners managing the Proof of Concept and testing scenarios
• Lead multi-threaded, globally distributed and complex projects
• Mentor less experienced team members on industry standard design practices
• Perform configuration, integration, functional specifications and development tasks for technology solution and services, including first implementation of the designed solutions
• Develop best practices for technology solution for reuse across the compute environment
• Ensure efforts and solutions align and adhere to the organization’s Technical Architecture Framework (TAF) policies, standards and direction as well as Solution Owner requirements
• Ensure proper training of support teams on the technology solution
• Stay abreast of operational difficulties and issues; work with support team staff to provide escalation support. 
• Document and optimize technology solution environment as required
• Ensure Quality standards as per company specifications are followed
• Occasional travel and working outside standard office hours including weekends and holidays

• Develop medical strategies based on strong scientific rationale for pre-launch and marketed products in Endocrinology, with a focus on growth disorders

• Establish standards for all Medical Affairs activities, including Sponsored Trials, Supported Trials, Registries and Exploratory Data Analysis of internal and external data bases, publications, medical education, medical communication, Advisory Boards and promotional review.  

• Participate on Franchise Leadership Teams contributing the medical perspective to franchise business strategies and evaluation of new product/development ideas. 

• Work in a cross-functional/matrixed environment, interfacing with Development and Global Medical Affairs personnel to provide the US Medical input into Development programs and Global Medical Affairs strategies

• Responsibility for the medical affairs budgets for the Growth Disorders Franchise to ensure adequate resources and their effective allocation. 

• Interact and manage relations on behalf of Genentech with Key National and Regional Thought Leaders in Endocrinology. 

• M.D. with board certification/eligibility in Endocrinology

Technical/Functional Competencies 

• Relevant therapeutic area experience in Endocrinology (5 or more years, inclusive of academic experience)

• Relevant biotech/pharmaceutical industry experience (2 or more years) strongly preferred

• Considerable experience in the principles and techniques of data analysis, interpretation, and clinical relevance

• Comprehensive understanding of product and safety profiles

Core Competencies / Other Key Behaviors

• Participate on cross-functional teams for evaluation of new products/ development ideas and implementation of franchise business strategies.

• Scientific leadership 

• Leading Teams

• Collaboration and Teamwork 

• Excellent Judgment and Analytic skills 

• Drive for Results

• Effective Communication 

• Integrity

• People Development 

The Business Solution Manager (BSM) position is part of a global team that supports Product Development Biometrics & Clinical Operations. This role includes working on major cross-functional system initiatives, providing user support, system upgrades/enhancements, and business case development as well as integrating business processes and technology. 

In this role the BSM proactively assesses upcoming changes in Statistical Analysis tools and internal business environments, in compliance with the IT standards/processes and identifies solutions in support of the following areas:

• Epidemiology and Patient Reported Outcomes (EpiPRO)
• Clinical and Non-Clinical Biostatistics (PD, gRED and pRED)
• Thesaurus Management and Coding 

The BSM will also support cross functional initiatives led by other business areas and provide process expertise to support the development of solutions that align with the Product Development Information Landscape & Biometrics Information Landscape roadmaps.

In partnership with Biometrics & Clinical Operations, Project Management and Delivery Services, the BSM responsibilities include but are not limited to:

• Development of Roche's Informatics Biometrics & Clinical Operations IT project portfolio in partnership with the customer, project manager and solution architect. 
• Drive harmonization of processes and practices across sites and departments through common standardized data models, applications and technologies that are in line with Roche's strategies and architectures. 
• Providing efficient and effective business processes and practices expertise in a global regulated environment 
• Development of strategies to enable existing Informatics systems to address changing Roche policies and directives. 
• Knowledge of analytical software like SAS and R, especially related to analysis of ‘Real World Data’
• Participating in Roche BSM Forum and collaborate with other BSM's  
• Actively participating in industry groups to understand the future of ‘Real World Data’ and strategy to incorporate in Roche's strategies and solutions.

Main Purpose of the Position:
• Direct staff and operations to manage and support multi-site investigations and CAPAs.
• Provide leadership and guidance to staff performing multi-site investigations and CAPA activities for the Biologics OU.
• Establish strategic goals and objectives to achieve department and company
• Manage performance and development of direct reports to ensure achievement of organizational and department goals and a productive environment.

Job Duties/Responsibilities:
• Manage and administer all aspects of people processes related to the employee life cycle.  This includes the selection, hiring and training of personnel on company and department policies, systems and processes.  Manage and communicate compensation related information per company guidelines.
• Coach and develop staff by providing an environment that encourages ongoing personal and professional growth.  Manage and ensure the setting of realistic personal goals for staff and provide regularly scheduled feedback throughout the year.  Ensure staff receives appropriate knowledge and skill development and growth opportunities.
• Interpret, execute and recommend improvements to Quality operational policies, plans and procedures.
• Provide input to department budget and monitor and control expenditures against the department budget.
• Provide input for the development of overall Quality objectives and long-range goals.
• Notify Senior Management of potential quality or regulatory issues that may impact product quality or regulatory compliance.
• Lead and participate in continuous improvement initiatives for Genentech Quality Systems.
• Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.
• Be accountable for behaviors described in the Roche Leadership capabilities.
• Perform any other tasks as requested by Senior Management to support Quality oversight activities.

Technical Duties/Responsibilities:
• Lead a team to manage and support multi-site Biologic investigations and CAPA.
• Support the development and manage the implementation of the Investigator Certification program.
• Sponsor and provide guidance for multi-site investigations and CAPA activities.
• Participate in the Quality review Board
• Develop and report metrics that focus on continuous improvement and ensure an effective and compliant investigation system.
• Partner with Site Quality Heads and other PT groups to with interdepartmental contacts on investigation assessment, resolution, and quality approval.
• Approve Quality Investigation.
• Perform timely escalation to Sr. Management of quality issues potentially impacting products, materials or processes
• Support sites during root cause analysis
• Lead Investigation and CAPA continuous improvement efforts
• Develop short-term goals and long-range plans to ensure effective utilization of Quality resources to support  
• Act as an advisor to internal project teams by providing extensive knowledge of regulatory requirements, industry standards, and company strategy. 
• Provide technical and quality assurance input during the review and approval of applicable documents. 
• Participate in the Quality Review Board.
• Manage the end-to-end investigation process
• Identify, facilitate and establish cross-site and cross-business unit processes to ensure efficient and timely investigation strategies.
• Ensure appropriate application and integration of cGMPs into the discrepancy management system.
• Educate departments on the best practices for conducting investigations and root cause analysis.
• Collaborate with departments to ensure process improvement proposals are practical and feasible.

Are you ready to create something that makes a real difference in people’s lives, rather than just a cool widget for the next internet startup?  What about creating tools that enable scientists and engineers to optimize cutting edge biochemical manufacturing processes that produce live-saving medicines for cancer and other unmet medical needs?

We do all of that at Genentech.  We have a small team that utilizes both agile and waterfall approaches (when it suits us) to create novel tools in a biotech manufacturing environment.  We create applications that simply do not exist in this industry – but are vitally necessary to advance the science of delivering new drugs that save lives.

We need someone to help develop and maintain applications in Perl, Ruby, ASP.NET, and some other platforms.  We do not require experience in all of these technologies, only a willingness to learn and expand your toolkit.

You will be responsible for the development and maintenance of the systems you build. You will be required to work both independently and also be part of a team. You are an excellent communicator and have a can-do attitude.

Key Responsibilities:

• Working with small teams, design, develop, test, document and implement GxP solutions based on customer requirements and translate them into functional solutions
• Provide deep technical expertise over a broad set of current technologies and platforms and mentor other team members in these technologies
• Deploy new software enhancements, troubleshoot production systems, contribute to root cause analyses and provide excellent customer service to a 24x7 manufacturing operation
• Work with a variety of in-house developed, commercial off-the-shelf (COTS) and open source software

• Follows all laws, regulations and policies that govern the conduct of all activities. Is accountable for being fully knowledgeable of all relevant policies and for abiding by these
• Does not compromise ethics or integrity, or undertake legal risks while pursuing business goals
• Asks questions when in doubt
• Demonstrates leadership among peers and subordinates by consistent application and modeling of the appropriate compliance, behavior and conduct
• If applicable, is required to obtain and maintain full proficiency and knowledge of disease state, product and other aspects or issues as provided for and mandated by the company

2. Planning & Development

• Act as a subject matter expert and a lead contact for FOIM Data Management – Field Operations IMS data sources and Genentech supplemented files production processes and projects
• Stays abreast of Commercial Operations and other business developments, to include external marketplace changes/developments, and uses where appropriate data to support recommendations to improve processes
• Recommends new opportunities to his/her manager and other business partners/stakeholders. Where approved, leads the development/implementation process for such new opportunities
• Works with manager, team members, gCOI, others in FOIM, other internal customers, partners and stakeholders and external vendors to review business requirements for Commercial Operations validation and sales data and plan for any new or updated data sources, systems, databases, interface, processing methods and/or reporting mechanisms
• Works with manager, team members and others to develop appropriate departmental plans and goals to address customer requirements. Where applicable, develops detailed project plans and participates in evaluating necessary resources 
• Participates in other planning and development meetings within FOIM and other Commercial Operations groups
• Participates in departmental policies & procedures development, which may include development and documentation of Standard Operating Procedures (SOPs) or other relevant guidelines. May take the lead role in departmental policies & procedures development, as assigned
• As appropriate and assigned, independently leads departmental or customer projects 

The Quality Engineering manager works independently and provides oversight of quality engineering activities during design development. Be the quality engineering subject matter expert during device development, manufacturing, technology and associated verification and validation. 

Job Responsibilities:

* Works closely with Device Development and device CMOs to assure that combination products maintain their requirements and specifications and are compliant with the Quality System

* Liaises with technical groups to review and revise specifications based on design and/or process changes

* Supports root cause analysis in the implementation of corrective actions

* Responsible for continual improvement activities and liaises with experts to apply appropriate improvement tools

* Provides technical consultation on the development of fixtures, methods, test equipment, and tooling in order to continually improve process and products 

* Establishes quality inspection processes and supports quality activities to ensure that products and processes comply with the relevant requirements of the quality management system.

* Supports internal/external audits and vendor qualification, including closing out audit findings and determining proper corrective and preventive actions.

* Responsible for planning, organizing, and managing the overall testing activities of quality functions.

* Collaborate on and /or author policies and procedures and act as a trainer / subject matter expert on applicable quality systems, standards or business processes (as required). 

* Set personal performance goals and provide input to departmental objectives and establish work priorities to meet targets and timelines. Maintain current status on all required job related training and strive to continuously improve knowledge and skills in quality, compliance and technology.  Perform any other tasks as requested by Management to support Quality oversight activities

* Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.  

Product Manager / Senior Product Manager

The Product Manager, Lytics Cathflo Marketing reports directly to the Group Product Manager and is responsible for:

Management of all peer-to-peer Cathflo programs including speaker's bureau, Cathflo Nurse Trainers, Cathflo Nurse Liaisons and national webinars.
Development of relevant medical education content and patient case studies for inclusion in peer-to-peer programs. Evaluation of nurse thought leader engagement strategy in partnership with the field and other internal partners.
Evaluating new means of marketing broadly to nurses, with a goal of driving an increase in habitual CVAD line assessment. Planning and execution of annual advisory boards in support of Cathflo, as needed. Contribution to the development and execution of the 3-year brand plan, and the 1 year tactical plan for Cathflo.

The successful candidate must have:

• Proven strategic agility in a complex marketplace
• Demonstrated experience in the development and execution of a sales or marketing plan
• Proven ability to partner effectively with field sales and sales leadership
• Considerable skill in influencing without authority
• Ability to provide rationale-based, succinct and persuasive oral & written communications
• Working knowledge of product development, regulatory and clinical affairs
• Demonstrated ability to establish thought leader and other relevant stakeholder relationships
• Strong analytical and project management skills, including previous experience working with budgets and analyzing market research results

Purpose:

The senior utilities engineer provides technical leadership and accountability for plant and GMP utilities engineering in the delivery of capital projects and engineering services for research and development (R&D) and quality laboratory, as well as commercial and clinical manufacturing related facilities.

Responsibilities:

• The senior utilities engineer will work effectively on multi-discipline engineering capital project teams, as well as other project related cross-functional teams with representatives from departments throughout the Pharmaceutical Technical Operations and R&D organizations.

• Responsibilities may extend to all regional Americas manufacturing and research facilities, as well as the network of Contract Manufacturing Organizations organized under the Manufacturing Collaborations group.

• The primary area of focus for this position will be the execution of projects from design through commissioning and qualification. The senior utilities engineer will be accountable for:

- Planning and Execution of Projects: including project approach and resource needs, options analysis, utility systems and equipment design, engineering document development, and system ownership through the project delivery phases of plan, design, procure, construct, commission and qualification for research, cGMP and development facilities; and 

- Technical Analysis:  including utility system and technology plant fits, capacity and equipment utilization, value engineering, sustainable design, constructability and assessment of applicable new technologies to balance performance, cost and maintainability.

• Areas of expertise include systems and equipment for purified water, water for injection (WFI), clean steam, process air, process gases and process waste, as well as associated knowledge in plant steam, plant chillers and utility piping.

• This position requires coordination of Genentech/ Roche and/or contract engineering resources.  Facilitating meetings, directing engineering firms and consultants, field supervision, equipment inspection and start-up, construction trade coordination, and training of operational staff are often required.  Success in these areas will depend upon the individual’s ability to effectively communicate, collaborate, and foster positive interactions with team members, while diligently managing adherence to project scope, budget and schedule.

• The senior engineer is expected to be an effective communicator of ideas, project goals and results.  With minimal supervision, is expected to make presentations and updates to senior management and in broader forums both internal and external to Genentech. 

• The senior engineer is expected to contribute to increasing the efficiency and effectiveness of the Engineering Technology department by contributing toward infrastructure improvements to guidelines, procedures, practices, standards and cross-functional business processes.  The senior engineer should share insights and improvements, participate in design reviews across the portfolio of departmental projects, and contribute to best practice forums across our network of global engineers and partners. 

Provides clinical oversight for a variety of projects, in consultation with his/her Medical Director or Senior Medical Director :

·         Works with a host of internal and external partners and stakeholders in the implementation of clinical trials for assigned drugs/indication

·         Provides scientific input into and/or coordinates the development of specific clinical trial documents for review and discussion with Medical Directors* (e.g., protocols, charters, safety monitoring plans, process documents, etc.) including disease and/or treatment registries

·         Participates in the identification of appropriate external investigators

·         Oversees the clinical trial implementation, ongoing monitoring and evaluation, working closely and regularly with external investigators and Clinical Operations. Active Member in Study Management Team for assigned drugs/indications

·         Develops and cultivates relationships with external partners such as clinical investigators, clinicians, scientists and KOLs, as well as cross-functional partners in Clinical Development, Commercial, Legal and Regulatory.

·         Supports his/her manager in developing clinical components of presentations* for clinical trial investigator meetings

·         In collaboration with his/her manager, coordinates the preparation and reviews data outputs for reporting documents* where appropriate (e.g. clinical study reports, analysis plans, etc.) with the CRO, the Medical Affairs Biostatisticians and his/her Medical Directors

·         Monitors project progress and is expected to proactively identify any issues or challenges and recommend and implement strategies to effectively resolve such once approved with his/her manager

·         Works closely with his/her manager, the publication team and Clinical Operations to complete associated publications, reviews draft publications*.

·         Keeps all partners abreast of projects progress throughout all applicable intervals

·         May also participate/coordinate collaborations with external stakeholders

(e.g. cooperative groups, other companies, etc.) on development and implementation of

approved clinical projects.

·         May coordinate, liaise with internal and external providers for data mining activities

·         Helps his/her manager provide data outputs requested for safety and/or other relevant sections of IND annual reports, if these sections and reports relate to assigned drugs and/or indications*.

·         May interact with NCI or other agency, as appropriate, with supervision from his/her manager

¿ Stays abreast of internal and external developments (scientific, clinical, commercial, competitive, legal, regulatory and like) as such developments may implicate or otherwise impact the implementation of the medical plan of the assigned drug(s)/indication(s). Includes attendance at major scientific conferences, participation in competitive intelligence activities, and review of published literature

Sales & Operations Planning (S&OP) Forecast Manager/Sr. Forecast Manager

The Sales & Operations Planning (S&OP) Forecast Manager/Sr. Forecast Manager manages and further enhances the S&OP process for the Commercial organization. This individual plays a key role in ensuring continuous supply of products to patients by collaborating with the Supply Chain organization to ensure supply and demand alignment, and to balance financial, manufacturing capacity, risk, and other considerations. The individual in this role will establish and maintain key partnerships across US Commercial, and Global and North America Supply Chain organizations.

Primary Responsibilities:

• Manage monthly S&OP forecasting process to ensure base case and upside demand forecasts are comprehensive, accurate and representative of the most appropriate demand plan in achieving Genentech business goals
• Prepare executive level presentations including demand analysis and scenarios to facilitate discussions and drive Executive Sales and Operations Committee (eSOP) decisions

• Develop metrics and collaborate with brand Forecast Managers to improve forecast accuracy
• Consolidate and submit demand forecasts for all SKUs of in-line and pipeline Genentech products to  the Supply Chain organization
• Prepare standard portfolio reports to provide insights to sales performance for Commercial senior executives
• Actively participate in various cross-portfolio initiatives including tools and system enhancements to support forecasting processes and reporting

Analytical Operations provides assay support for Process Technical Development in GMP and R&D environments.  The hire will be mainly responsible for performing HPLC, CE and LC/MS assays, data processing, and development of HPLC methods. Responsibilities also include assay reagent and instrument maintenance, and assay troubleshooting.  Position requires working closely with other members of the department in a team setting, as well as extensive interaction with other departments. Handling of biological and chemical reagents is required.

This is an exciting opportunity within the Drug Substance Global Biologics Manufacturing Sciences and Technology (DS GBMSAT) department in the Pharma Technical Development organization.  GBMSAT provides technical leadership to develop solutions in support of commercial manufacturing across the internal and external Roche network.  GBMSAT plays a critical role in enabling the network concept for the MSAT network across Roche.   Additionally, GBMSAT provides technical leadership for technology transfers to contract manufacturing organizations.

The primary responsibility of this position will be to focus upon clinical product planning for multiple molecules; which includes partnering with Clinical Operations to translate trial assumptions into drug forecasts, utilizing SAP/APO to develop supply plans and to align these supply plans with the Technical Development Team, and partnering with Master Production Planners (MPP) to ensure plans are converted into bulk, filling, packaging, and contract manufacturing schedules which meet customer requirements.  For Finished Goods, the CDSL is also accountable for generating a distribution plan to handover to the Global Clinical Distribution team and working with this group to ensure a seamless supply chain throughout our distribution network.  The CDSL will be knowledgeable of the costs and capacities associated with our manufacturing network, and will assist the MPP in developing recommendations to balance production requirements, customer service, and manufacturing capacity.  The CDSL will assist in the execution of our Clinical Demand & Operations Planning process, in capturing supply planning metrics and in developing/implementing strategies to drive improvement in those metrics; enabling the development of robust business processes and our ability to reach our department goals.

Responsibilities:
¿ Partner with Clinical Operations teams to develop drug forecasts based upon clinical trial assumptions, design, and timelines
¿ Leverage the Generic Forecast Assumption process to apply drug forecasts to future planned trials listed in Plansource
¿ Collaborate with Development Partners to understand partner demand and timelines for trials not being run by Genentech
¿ Initiate product definition forms to enable creation of new planning and execution items in SAP
¿ Utilize clinical forecast tools to consolidate all demand for Roche/Genentech, or CMO produced drugs as well as required Other Study Drug procurement
¿ Utilize SAP to create/communicate a Master Production Plan, a depot Distribution Plan and OSD procurement plan that meets global clinical demand, inventory targets, project budgets, and manufacturing capabilities
¿ Actively participate on TDT teams to ensure alignment of demand and supply plans with TDT development strategy and budget, and capture all project driven demand in SAP
¿ Lead cross-functional Global Supply Execution Teams to drive alignment of activities enabling drug to be packaged, released, and ready to ship; meeting trial First Site Activation goals
¿ Manage inventory and production orders for assigned products; monitoring inventory levels, firming production orders, controlling lot allocations, managing expiration dating
¿ Perform required Supply Planning activities & processes driving cross functional action to ensure all drug supply plans are achieved
¿ Participate in the S&OP process as necessary, leading cross-functional process improvement RCAs

MEDICAL DIRECTOR/MEDICAL DIRECTOR - 

RESPONSIBILITIES:

Genentech is seeking a Medical Director with clinical and drug
development experience within our Development-Immunology organization. This individual will be responsible for strategic clinical
oversight with a focus on our scleroderma portfolio. The position will involve clinical development of novel agents. The Medical Director will be responsible for the design, implementation,
monitoring, analysis, and reporting of studies conducted within one or more programs.
They will also participate in developing the long-range strategic plans for the molecule or molecules.

Division/Function: 

GPPS-EACM / Service Provider Mgt

Position Purpose: 

Develops and delivers high value sourcing models and outsourcing strategies on the IxRS service category to support the out-sourcing needs of PD, pRED, gRED, GPS and GMA/gMED 

Main Responsibilities and Accountabilities:

In general

* To develop and refine a strategic sourcing plan for the category including determination, implementation and management of the applicable governance structure

* To liaison with Roche stakeholders (PD, pRED, gRED, GPS and GMA/gMED) to ensure that the Biometrics sourcing strategy is aligned with in-house capabilities, with current and future needs and capacity

* To provide advice and guidance to GPPS Contracts & Outsourcing Business Managers in the development and management of key service area domain contracts as well as to provide advice and guidance to project and/or study teams on this category 

* To manage all individual service provider relationships within the category, including contractual (MSAs), vendor performance and issue resolution

* To lead performance management with service providers and to facilitate/expedite issue resolution 

Specific to IxRS Key Service Area:

* To maintain an oversight of the IxRS category including ongoing management of spend and demand (including identification of efficiency and value adding opportunities). This category includes over time oversight of spent for  also ePRO/PRO 

* To act as IxRS subject matter expert; contribute or lead relevant IxRS initiatives (i.e. cross functional working groups), maintain awareness of IxRS services, developments and providers globally