The AE&O Senior Project Manager scopes, plans and manages local, regional and global IT projects consisting of one or more delivery streams. He/she works with solution owners and project sponsors within AE&O (Architecture, Engineering & Operations) and SP&A (Shared Platforms & Applications).

As part of a team of project management professionals he/she reports to one of the Team Leads of Project Management within AE&O Project & Portfolio Management and is supported by portfolio analysts of the AE&O PMO and SP&A PMO (if applicable).

The Senior Project Manager is responsible for scoping, planning, managing and controlling global IT projects and reporting in a timely, accurate and transparent manner following standardized methods to allow accurate portfolio management and project execution control within AE&O and SP&A.

The senior project manager works closely with a responsible portfolio analyst from the PMO in AE&O (or SP&A) to ensure timely and accurate project reporting on project scope, schedule, cost and resources, as well as project risks, issues, action items, and dependencies.

In addition the senior project manager needs to collaborate closely with the Finance, Quality & Procurement departments as required. Also the involvement of other Pharma IT areas outside of AE&O and SP&A (as internal project workforce) might be required (e.g. Roche’s Shared Service Center in Warsaw).

Major Responsibilities include:

• Project Scope Management - Formulating and defining scope and objectives of the project in collaboration with the responsible Solution Owner and ensuring communication of project goals, schedule baselines, and business direction to all identified stakeholders
• Project Stakeholder / Communication Management - Identifying all relevant project stakeholders and establishing and implementing an appropriate communication plan to manage their requirements
• Project Delivery Primarily - Delivering the project on time, on approved (baseline) budget, within quality limits, and with the expected benefits, as defined at project entry and project baseline gates and through controlled and documented change management throughout project delivery, as needed
• Project Risk, Assumption, Issue and Dependency (RAID) Management - Actively managing risks, assumptions, issues and dependencies (RAID) by carefully assessing potential impacts in collaboration with the respective project teams and proposing appropriate mitigation actions. Is also responsible for identifying, actively managing and integrating with any dependent projects or activities.
• Project Planning, Tracking, Control & Reporting - Creating baseline project schedules and tracking the completion of project deliverables, tasks, activities and milestones. Providing accurate, timely and fit for purpose project status reports using established norms and reporting tools of the portfolio
• Team Building & Leadership - Organizing and supervising the appropriate involvement of project resources and actively managing and addressing the resolution of conflicts within the project team.
• Compliance – Directly accountable for ensuring compliance with project management, portfolio management and CSV policies, guidelines, process tools and reporting standards of the portfolio. These norms will include all system qualification/validation state documentation, project documentation and resource forecasting/tracking, financial forecasting/tracking and governance procedures of the portfolio for the specific projects assigned

The Network Operations Manager will be responsible for providing leadership and technical guidance to a team of Network Engineers throughout North America. He/She will ensure timely response to all alerts, resolving or escalating issues as appropriate while working closely with internal customers to assure continued quality of service. The Network Operations Manager will lead various transformative Network initiatives (Network redesign, infrastructure upgrades, new buildouts), both strategic and tactical in nature, that will address our most important challenges including scalability, stability, and an increasingly complex network. He/she will manage the network in accordance with identified service level agreements (SLA), KPIs, policies, and procedures.  This individual is key in maintaining the highest level of service for our customers, both internal and external.  Additional responsibilities include:

• Delivery services include long range planning, project management, internetworking, network monitoring, capacity planning, asset management, problem management and change management.
• Project responsibilities include managing the North America Network project portfolio approval process; managing project managers and their project activities; monitoring project status; acting as an escalation point for risk mitigation and issue resolution; and tracking project deliverables, schedule and budget to ensure successful project outcomes. 
• Develops annual budgets, and life cycle maintenance projects in order to maintain the corporate network infrastructure.
• Works with our Network Architecture and Engineering organizations to develop initiatives to ensure the strategic fulfilment of business needs, lifecycle management, and continuous improvement, as well as overall customer experience and satisfaction for a specific solution.
• Is responsible for leading (and providing direction for) many vendor initiatives, contracts, and service negotiations. Works closely with vendors, monitoring service delivery, evaluating new technologies, products and services to better position the company from a data networking perspective.
• Constantly reviews and refines support documentation, processes, and procedures. 
• Reports on SLAs and metrics for the performance of the network

This role provides technical and business leadership to IT and our internal business partners; its primary focus is developing and improving business processes. The individual acts as a business relationship manager responsible for the collection, analysis, review, documentation, and communication of business requirements and needs. The individual also acts as a liaison between IT and business units or vendors, establishing relationships with employees and key stakeholders. The individual is responsible for designing solutions with architecture, engineering, and various IT entities. The role also assists with the development of metrics, both within the technology and business organizations. The solutions must be developed at the best possible cost and aligned with customer and business needs. The individual oversees the development and implementation of corporate standards, technology architecture, technology evaluation, and life cycle. To be successful, the individual must possess a combination of business, technical, and leadership skills. This requires an understanding of customers’ business needs, processes, and functions.  They also need a solid knowledge of IT infrastructure, architecture, applications development, and support. In addition they must possess excellent communication skills and the ability to influence others. They must be able to quickly assess the impact of technical issues on the business and make decisions appropriately

Main Purpose of the Position:    

·         Support the development, implementation and management of the overall environmental control program in SSF Drug Substance and Drug Product Manufacturing following, cGMP regulations, Genentech and Regulatory requirements.

·         Provide Quality oversight from and critically evaluate EM issues, discrepancies, Media Fill data, airflow evaluations, and assess facility/process changes.  

·         Develop solutions to complex issues and Quality initiatives with inter-organizational impact.

·         Perform tasks and work to achieve company goals and organizational objectives.

Technical Duties/Responsibilities:

·         Provide oversight of the Environmental Monitoring (EM) program ensuring consistency with company/regulatory policies and procedures.

·         Present and provide rationale of EM program during periodic audits and regulatory inspections.

·         Provide input in the preparation of regulatory submissions.

·         Provide input into investigations involving suspect equipment, utility or facility failures resulting from EM activities.

·         Provide Quality oversight throughout the Drug Substance and Drug Product Manufacturing areas. 

·         Provide technical assessment and approval for changes to the EM program.

·         Collaborate with departments to ensure that EM activities are executed efficiently and effectively.

·         Provide oversight to the Media Fill program and create Media Fill protocols and summary reports.

·         Execute Airflow Visualization studies and create summary reports.  

·         Provide guidelines for area/system Shutdown Authorization Request (SAR) activities.

·         Ensure proper policies and procedures are established to guide EM efforts.

·         Ensure department representation on relevant project teams.

·         Identify, design, and implement environmental monitoring process improvements.

·         Communicate group performance against established metrics to Quality Management.

Reporting to the Senior Director of North America Pharma Compensation, the Manager of Executive Compensation is responsible for providing compensation services and support for all executive level employees across North America Pharma.  This position will provide expertise, as well as project leadership on all aspects of compensation for executives including but not limited to management of base salaries, short and long-term incentive plan analysis, retention plans, position evaluations, market data and internal equity analyses. This individual will also serve as a senior internal consultant and key thought leader responsible for providing consultation on various executive compensation matters to senior executives and human resources.

Primary Responsibilities:

• Provide expertise in all areas of compensation for executives, including base salary, short and long term incentive programs, job evaluations, market data and trends.
• Oversee the annual salary increase, bonus, and long-term incentive award process for executive level employees.
• Partners with Business Unit Principal Compensation Managers to:
• Develop competitive offers for external executive level hires.
• Develop promotional and off-cycle increases for executives.
• Manage the job evaluation process of new and revised executive level positions.
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• Prepares all analyses, presentations, speaker notes and materials for management presentations to senior leadership.
• Provide consultation on executive compensation matters to senior leaders and Human Resources.
• Conduct yearly review, analysis and updating of benchmarks and survey results.
• Participates in executive compensation and HR metric surveys for trend and program design information.
• Reporting on current events and regulation updates related to executive compensation as well as maintaining comparator company information.
• Performs other job-related duties as assigned.

Knowledge, Skill, and Abilities:

• Excellent written and oral communication, presentation and interpersonal skills are required to communicate effectively and professionally across various levels of the organization and with key external customers and vendors.
• Proficiency in partnering with business and HR leaders to drive company strategies.
• Ability to establish credibility with numerous constituents and be seen as a thought leader.
• Strong research, analytical, business process analysis and problem solving skills with an internal customer focus.
• The ability and skill to manage multiple projects, maintain momentum and meet deadlines on time and within budget.
• Strong networking capabilities and skills at working moderately complex issues.
• The ability to overcome obstacles and adapt approach to achieve outstanding results.
• Strategic and hands-on approach to compensation including the ability to creatively conceive of concepts and then personally run models to determine feasibility.

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 Network Engineer, 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
• 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

We are seeking a Project Manager who will manage projectsto successful and timely decision points from Late Stage Research throughProof of Concept.  The Project Manager will contribute to the definitionof project strategy and guide the project core and sub teams to deliver onproject objectives.  This position will be accountable for steering drugdevelopment teams through corporate processes.  Additionalresponsibilities include but are not limited to the following:

·        Establish and maintain functionally integrated project schedulesto enable accurate project, financial and portfolio analyses and ensureaccurate inputs are provided into business planning processes; Ensuresalignment with project sub-teams and functional partners

·        Oversees and prepares project team budget including resources andcosts collaborating with Finance and other cross-functional departments

·        Communicate, document, and archive project team activities anddecisions; act as a primary contact for project team related information

·        Facilitate project team meetings, cross-functional communicationand decision making, ensuring alignment with internal and external stakeholders

·        Identifies, recommends and implements opportunities forstreamlining team and business processes.

·        Partnerswith the team leader to ensure the team achieve and maintains a high-level ofsustainable performance, by contributing to appropriate team management bestpractices.  

Main Purpose of the Position

* Manage the lifecycle of contract manufacturing activities for commercial products at one or more bulk drug substance (DS) third-party contract manufacturing organizations (CMOs), including CMO selection, process technology transfer, routine cGMP manufacturing, and site decommissioning upon completion of the contract.  

* Establish and maintain alignment between CMO site business, operational and quality objectives and plans and Roche’s commercial and manufacturing strategies and plans.

* Establish and manage business, operations, and quality relationships and communications between Roche and the CMO as the Roche’s single point of contact for the contract manufacturing relationship at the Joint Management Committee and Joint Steering Committee levels.

* Build and lead cross-functional teams of technical, quality, regulatory, manufacturing, engineering, supply chain and other subject matter experts to achieve CMO site business, operational and quality objectives, plans, and performance goals.

* Provide the single point of accountability for identifying and managing timely resolution of business, operational, and quality issues through the established CMO site governance structure.

* Manage the performance and development of direct reports as required to achieve organizational and department goals and a productive work environment.

Job Duties/Responsibilities 

Contract Manufacturing Lifecycle Management

1.   Selection.   Build and lead the Roche cross-functional team charged with for identifying, evaluating, and selecting and negotiating a contract with a CMO for bulk contract manufacturing, specifically:

* Develop CMO selection plan, define contracting manufacturing requirements and evaluation criteria, and identify and screen CMO candidates.

* Develop Request for Proposals (RFPs), and solicit and evaluate contract manufacturing proposals.

* Lead due diligence visits, analyze and evaluate CMO proposals, and develop recommendation(s) for CMO selection.  Drive decision-making for CMO recommendation through appropriate governance committees.

* Lead contract negotiations for technology transfer and manufacturing and supply agreements.

2. Implementation.  Build and lead the cross-functional team charged with transferring, qualifying, and achieving regulatory licensure the process and analytical technologies (“technology transfers” for manufacturing Roche’s DS products at a CMO’s manufacturing facility, specifically:

* Lead the Technology Transfer project for Roche through regulatory licensure of the CMO’s facility for routine cGMP manufacturing, including serving as the Leader of the Joint Management Team.

* Plan and manage the transfer of Roche’s DS manufacturing process(es), analytical testing technologies, and supply chain processes to achieve product and process comparability between the donor and receiving sites.

* Manage the project governance structure, including identifying and managing issue resolution and milestone stage gate reviews.   

* Oversee and manage contractual commitments, obligations, and processes, including milestone dates, financial terms, dispute resolution, and materials and equipment.

3.   Site Management.  Build and lead the cross-functional team charged with managing contract manufacturing at CMO following regulatory licensure, specifically:

1.1. Business

* Serve as Roche’s Site Manager, actively managing the on-going relationship with CMO to ensure Roche’s expectations for product quality, cGMP compliance, costs, and production targets are clearly understood, well-documented and consistently met.

* Lead project team meetings and technical operations meetings.

* Coordinate and manage visits and contact between Roche personnel and the CMO.

* Establish and maintain a Joint Service Agreement with the CMO that defines roles and responsibilities, business processes, systems and tools, supply chain assumptions and standards, and performance metrics to foster an effective and efficient business relationship. 

* Manage and monitor contractual commitments, obligations, and processes, including milestone dates, financial terms, schedules, materials, and equipment.

1.2. Operations

* Serve as site Technical Lead, coordinating technical review of process data and proposed facility, equipment, system, or process changes with Roche Subject Matter Experts (SME's).

* Facilitate issue resolution and problem solving within CMO site, with Roche functional departments supporting Contract Manufacturing, and through the agreed project governance structure as appropriate.

* Coordinate cross-enterprise forecasting, capacity planning, scheduling, and inventory management processes for critical raw materials and DS.  

o...

We are seeking a candidate for a postdoctoral position in the Department of Molecular Biology, to investigate vascular processes.  Research topics include Notch, BMP, Tie2 and EphB4 signaling pathways, and roles of microRNAs in vascular biology.

This position involves global medicine development activities of a novel biologic agent targeting indications in the field of respiratory diseases.

This job creates a unique opportunity to join a global team that is currently defining its structure and both short-term and the long-term deliverables, and to grow with the team and the franchise.

 As the Medical Director you will be responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted within one or more programs. You will also participate in developing the long-range strategic plans for the molecule or molecules within the area of inflammatory diseases.

Key Accountabilities will be:

Assisting in the overall management, planning, evaluation and documentation of projects and studies

Participation in on-going medicine development activities including:

• Preparation of regulatory documents and interaction with global regulatory authorities
• Monitoring and reviewing incoming data
• Analysis, presentation and interpenetration of on-going studies and published data
• Interactions with health authorities and expert bodies
• Close collaboration with drug safety, regulatory affairs, medical affairs and clinical trial operations
• Participation in the preparation of abstracts, posters and presentations for scientific meetings and congresses
• Developing and writing clinical plans and protocols ensuring that they are scientifically sound

To be successful in this role, you will have the following skills and experience:

• Solid experience in medical research including writing clinical study reports and interpreting clinical data
• Good communication and collaborative skills with experience at working with cross functional and external groups, including researchers, clinicians and other stakeholders.
• Proven track record of delivery of experimental or novel studies
• Confidence at presenting at internal and external strategy meetings

Genentech is seeking an Assistant/Associate Medical Director to participate in the development and execution of the clinical initiatives within the clinical ophthalmology group at Genentech. The Assistant/Associate Medical Director will be a key contributor in building an integrated development plan late development, will provide support to new development activities for Lucentis, as well as clinical guidance and assessment of future opportunities to advance the science and address unmet needs in ophthalmology.

RESPONSIBILITIES:

-Trial design, protocol development, and execution (Phase II-IIIb)
-Development assessments of clinical programs to support life-cycle
plan and new therapeutic initiatives with a focus on biologics and
ophthalmology.
-Clinical lead on implementation teams- -providing subject matter
expertise, clinical science support and functional representation
-Interact with the FDA, corporate partners and cross-functionally
across Genentech
-Build relationships and scientific outreach within the ophthalmology/retina specialty community
-Participate in cross-functional teams for the evaluation of new
development ideas, franchise medical strategies and business development assessments.
-Contribute to authorship and review process for scientific
publications and presentations.
-Assist with advisory board activities.

A Senior Scientist/Associate Director position is available for a highly motivated and innovative scientist with strong leadership and collaborative skills to join our antibody drug conjugation (ADC) program.  Candidates should have extensive experience in protein and antibody conjugations and be a demonstrated thought leader in the ADC field so that they will be able to make immediate contributions to a vibrant and productive program undergoing expansion at this time. The successful candidate will interface with both chemist and biologist in developing new technologies for the production of ADCs as well as optimizing current strategies. The position allows the successful candidate to play a pivotal role in augmenting Genentech’s strong clinical pipeline of new therapeutic ADC candidates.

As the Medical Director you willbe responsible for the design, implementation, monitoring, analysis, andreporting of studies conducted within the Late Development Oncologyorganization. You will also participate in developing the long-range strategicplans for the molecule or molecules within the area of Oncology.

Key Accountabilities:

Assisting in the overall management,planning, evaluation and documentation of projects and studies

Participation in on-going medicinedevelopment activities including:

•  Preparation of regulatory documentsand interaction with global regulatory authorities

•  Monitoring and reviewing incomingdata

•  Analysis, presentation andinterpenetration of on-going studies and published data

•  Interactions with health authoritiesand expert bodies

•  Close collaboration with drugsafety, regulatory affairs, medical affairs and clinical trial operations

•  Participation in the preparation ofabstracts, posters and presentations for scientific meetings and congresses

•  Developing and writing clinical plansand protocols ensuring that they are scientifically sound

To be successful in this role, youwill have the following skills and experience:

•  Solid experience in medical research includingwriting clinical study reports and interpreting clinical data

•  Good communication and collaborativeskills with experience at working with cross-functional and external groups,including researchers, clinicians and other stakeholders.

•  Proven track record of delivery ofexperimental or novel studies

Confidence at presenting at internaland external strategy meetings

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.