Franchise: Rheumatology

Product:  Rituxan RA

Territory: N.Minnesota / N. Dakota

 

 

The Clinical Specialist, Franchise Sales manages and develops long-term relationships with physicians and other customers for the customer accounts in the assigned territory. As such, Clinical Specialists represent the assigned GNE brand(s) and their approved indications; helping external customers such as physicians, nurses, etc. learn about the benefits of the assigned GNE brand(s) in relation to the applicable therapeutic area/disease state.

 

Reports to: Division Manager, Franchise Sales

 

Example Duties and Responsibilities:

• Responsible for meeting or exceeding assigned sales targets
• Develops robust territory business plans
• Develops strong and long-term relationships with customers in all assigned accounts
• Presents the assigned GNE brands in a professional, compliant, ethical and effective manner; helping external customers understand the benefits and use of GNE brands
• Monitors operating costs and compliance with territory budget
• Complies with all laws, regulations and policies that govern the conduct of GNE activities
• Business travel, by air or car, is regularly required

 

NOTE:

This position requires significant use of either a company provided or personal vehicle to perform the essential duties and responsibilities of the role.  As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business.

...

The Principal HR Business Partner is the "local" HR business partner for the Finance and Procurement organizations based in South San Francisco and is part of the Corporate Groups HR and Employee Relations team.  This role is the strategic business partner to leaders and leadership teams within the client organizations, including one Genentech Executive Committee member.  This position will have to manage complex/matrix relationships on both a local and global level, collaborating effectively across business and HR networks/partners. 

The person in this role will consult, advise, coach and partner with the business on people and organizational needs -- ensuring alignment with agreed Group, functional and regional/site initiatives as well as business strategy.  This role also partners with leaders to drive organizational effectiveness including change management.

RESPONSIBILITIES:

• Act as key HR point of contact, trusted advisor, and sounding board for client LTs.
• Identify, define and implement solutions that address the needs of the business whilst taking into account the broader implications (e.g. Group HR strategy, other functions).
• Contribute to the business strategy. Drive the People Agenda by applying broad HR skills in the areas of organization design and development, change management, workforce planning, coaching/consultation, program/project management, facilitation and communication. Plan and implement people/organization solutions aligned to the business & Group HR strategy and goals (i.e., actively sponsoring and leading goals at LT level).
• Ensure excellent alignment and execution of established human resources policies, procedures and Group, functional, and site HR initiatives.
• Successfully execute global and local HR processes (for example, talent management, succession planning, performance management, development planning, compensation planning).
• Partner with Global/Regional HRBPs to align and execute on initiatives and Group processes (this includes providing input to and leveraging tools and templates from CoEs where appropriate).
• Identify talent issues before they affect the business. Act as a talent scout for internal talent for local and global key positions and help develop the next generation of leaders through talent management and career development. Contribute to assessment/selection for senior leaders and other critical positions.
• Determine most efficient and effective way to deliver services based on costs, ratios and appropriate Key Performance Indicators. Collaborate with service organizations.
• Ensure compliance of all HR practices within area of responsibility and with legislative and regulatory requirements, standards and other known relevant policies and guidelines.

...

As a key member on project teams the Global Project Manager II (GPM II), Product Development-Project Excellence (PDP) is expected to actively contribute and challenge the definition and development of project strategy, and then help teams to effectively and efficiently deliver on the strategic objectives agreed with the relevant governance body. The GPM II partners with the team leader to anticipate, identify, manage and communicate project risks. GPMs achieve this by delivering high quality project management support and other high value services:

• Applies project management expertise
• Takes accountability for all project management aspects and works
  effectively and closely with the project leader / team leader (PL/TL)
• Enables generation of innovative, exploratory and/or confirmatory options through project management expertise
• Ensures consistency of project planning from exploratory through to confirmatory development and health authority submission
• Contributes to the functional excellence development of project management
• Provides project management expertise to Due Diligence

The Global Project Manager II is accountable for:

• The development, maintenance, pro-active tracking & management of a high quality, ambitious integrated project plan
• Closely and transparently manage the critical path of the project
• Effectively guides a due diligence team through the formation of a comprehensive drug development plan and budget
• Maintaining, tracking, reporting and understanding variances in the integrated project budget by working in close collaboration with functional contributors and finance
• Guiding and managing the team through the value chain processes ensuring effective and efficient team operation
• Excellent interpersonal skills, including clear, succinct and timely communication and proven ability to foster important relationships with customers and key stakeholders.
• The integrity and accuracy of project information to meet team, management and portfolio requirements.
• Partnering with the team leader in identifying, managing & communicating key project risks and leading risk management strategies

...

We are seeking candidates for a postdoctoral fellow position in the Ashkenazi lab to study the molecular mechanisms that control apoptosis activation in response to cell stress. 

...

Responsibilities      

• Perform technical and compliance review of analytical testing results for bulk, final product, pre-clinical, cell banking and stability products
• Compile analytical data for bulk, final product, pre-clinical, cell banking and stability products
• Set up stability studies for clinical products in accordance internal PQS and ICH stability guidelines. 
• Plan and prioritize new stability studies to ensure regulatory submission timelines are met.
• Review and approve time point data to ensure regulatory compliance.
• Manage inventory of all stability studies, including sample submission to partner labs and cycle counting
• Assess and approve discrepancies of clinical and pre-clinical products
• Technical proficiency in analytical methodology and adherence to cGMP compliance
• Train colleagues on stability, assay review and analytical methodology as appropriate
• Identify and address gaps in systems and procedures for continuous improvements.
• Accomplish corporate, operational and departmental goals
• Exert influence in the development of objectives and long range goals of the organization
• Make independent decisions around complex issues in alignment with Roche policies
• Support internal and external audits
• Work with internal departments and outside vendors, collaborators and partners concerning projects and commitments
• Mentor and supervise (as required) other staff members on QC related, processes and projects.

...

In this position you will be responsible for managing a framework which allows you to control, administer and deploy many different packages to our Mac population.  You will be charged with managing our inventory/asset management system and responsible for local user policy enforcements, deploying packages, updates and applications, image creation and deployments.  You will be performing thorough internal testing, working with team members on quality assurance and distribute the software via System Casper to the production environment.  In addition to software packaging, this role requires a strong JSS Casper Suite software distribution foundation with the ideal candidate having experience in implementation of machine based distributions on a global scale.

• Defining desktop hardware standards and work with engineering to secure the standard corporate image.
• Implementation and design of software distribution through Jamf/Casper and support distribution points.
• Assist application owners with the planning for the certification and deployment of new or upgraded applications including assisting with the creation of install instructions and test scripts.
• Communicate and collaborate with other IT services providers especially in the supporting areas and project/portfolio managers and ensure that every affected group is communicated to and has signed-off on the stability and readiness of the application/software.
• Participate in all aspects of the application lifecycle for applications supported within the OSX workstation environment. This includes research, analysis, testing, certification, documentation and support. 
• Assist in providing 2nd and 3rd level support with any application issue once deployed.  
• Work with engineering to develop strategies for Genentech’s operations management.
• Work with engineering to design and deploy solutions to the desktop.
• Interact with vendors and functional teams in order to restore services and correct core problems. 
• Perform daily administration, configuration, application integration, functional specifications and development tasks for infrastructure technologies and services.
• Handles and tracks routine incidents and problems and develop support procedures, technical documentation and other related documentation 
• Develop best practices and deployment services for reuse across the enterprise.
• Monitor trends and use the information to suggest and develop continuous improvements to the operations of the solution.
• Work with engineering to document and optimize current infrastructure environment.
• Under limited supervision, responds to and diagnoses problems for enterprise-managed applications and systems and/or routine hardware, software, and network problems. 
• Ability to work in a virtual team atmosphere while being self-motivated with minimum direction in a fast paced environment; as an integral part of a virtual team, you will work closely with other Team members and supporting departments across the globe

It is expected and required that he/she has current knowledge of business processes and IT industry trends and developments.  He/she is expected to have excellent inter-personal and project management skills and team work experience with operations and support staff.  Have delivered and deployed a number of IT services, systems and components.  Additional experience and knowledge of Microsoft System Center Configuation Manager or JAMF Casper Suite and related infrastructure.

The person must have a minimum of 5 year’s experience working in a medium to large company performing infrastructure implementations and operations and excellent knowledge and experience working with information management disciplines such as: server, storage, security, integration and applications. 

...

The Senior Administrative Associate (SAA) position provides full and diversified administrative support to designated members of Genentech Informatics (GI).

Duties will include, but are not limited to:

• Coordinating meetings and events making travel arrangements, preparing reports and interacting with customers and vendors.
• The SAA must be able to utilize good judgment in managing calendar appointments and access to Manager’s schedules.
• The SAA will also be responsible for coordinating, assembling and packaging presentations, agendas and other meeting materials.
• The SAA will be expected to manage conference room scheduling and coordinate meetings with other Managers within GI and across the Company.
• They must be professional in demeanor and appearance, and courteous and friendly.

...

POSITION:

Finance Manager (G&A Finance)

Reporting to the Associate Director, G&A Finance, the Finance Manager will provide strategic and traditional finance support to the Workplace Effectiveness, EHS and Security groups within the Site Services organization.  Workplace Effectiveness includes Genentech Real Estate, Workplace Planning, and SSF Site Engineering.  The role will interface with key stakeholders within Site Services, Finance, and other areas within the Genentech/Roche organization.

JOB DESCRIPTION:

Manage and coordinate planning deliverables to meet corporate objectives and deadlines. This includes annual budget, quarterly forecasts, the 5 Year & 10 Year Business Plans 

• 
  
• Manage the month/quarter end close processes including journal entries, accruals, account reconciliations, reporting, detailed variance analysis of results
• Member of the Workplace Effectiveness Forum - provide financial and non-financial support to assist in strategic decision making
• Build and maintain effective and collaborative business partnership between the Finance team and Workplace Effectiveness stakeholders
• Proactively identify, design, and implement enhancements to existing processes
• Propose and implement innovative solutions to complex business issues through ad hoc analyses
• Effectively communicate financial information with all levels of the organization, including senior management

...

Job Summary

The Senior Statistical Programmer Analyst (Senior SPA) works with cross-functional teams in Medical Affairs and external vendors and leads the activities in the planning, design, development, implementation and management of software and data to fulfill reports and summarized information required in support of post-marketing clinical trials, registration studies, investigations and assessments of claims databases, including health economics and outcomes research projects for Genentech and Roche products. The Senior SPA also supports internal and external requests for input into relevant documentation and materials, such as manuscripts, conference posters and presentations.

Job Responsibilities:

• The Senior SPA provides expert guidance and direction regarding statistical programming design to support timely, targeted and accurate reporting and outcomes from assigned medical affairs projects.
• He/she works closely and collaboratively with internal cross-functional partners to ensure thorough representation and alignment of cross-functional programming, data and reporting needs and objectives.
• He/she expertly manages external vendor partners supporting software developments, enhancements, maintenance and reporting to ensure consistently on-time, on-target, and accurate deliverables.
• He/she provides timely, accurate and adequate responses and inputs to/into internal and external questions, medical affairs documentation and materials.
• He/she competently and independently develops, manages, and maintains software analysis data and reporting deliverables for assigned Genentech and Roche products.
• The Senior SPA provides technical solutions to a wider range of problems with higher level of complexity, independently determines and develops approach to solutions, and recommends technical and process solutions that can be used or developed to increase efficiency of project work.
• The Senior SPA also effectively represents the department, as assigned, on cross-functional projects or work teams, and also helps on-board new team members, as appropriate, and completes special projects as assigned.

...

MainPurpose of the Position:

• Lead the planning, preparation, and conduct of QualityAssurance staff performing a variety of routine and complex oversightactivities that meet cGMP regulations and Genentech standards.
• Lead DP MQA performance and development of direct reports toensure achievement of organizational and department goals and a productive environment.

JobDuties/Responsibilities:

• Coach and develop staff by providing an environment thatencourages ongoing personal and professional development.  Manage and ensure the setting of realisticgoals for staff and provide regularly scheduled feedback throughout theyear.  Ensure staff receives appropriateknowledge and skill development and growth opportunities.
• Manage and administer all aspects of people processesrelated to the employee life cycle.  Thisincludes the selection, hiring and training of personnel on company anddepartment policies, systems and processes. Manage and communicate compensation related information per companyguidelines.
• Accountable for systems to ensure anynon-compliant events occurring in Manufacturing are assessed in a timely manneran in compliance with Quality policies and Health Authority expectations.
• Accountable for systems to ensure documentationis reviewed in a timely manner and with a high level of accuracy.
• Guide staff in meeting goals by identifying and completingassignments.
• Recommend and implement improvements to Qualityoperational policies, plans and procedures.
• Manage routine department activities and complexQuality initiatives.
• Ensure activities and initiatives are completedon time and within budget.
• Maintaincapacity model to ensure appropriate resourcing of the area.
• Presentcomplex quality issues and potential solutions at site leadership teams (QRB,Quality Council, SMART)
• Monitor and control expenditures against the departmentbudget.
• Notify Senior Management of potential quality or regulatory issues thatmay impact product quality or regulatory compliance.
• Lead and participate in continuous improvementinitiatives for Roche Quality Systems.
• Sign documents foractivities as authorized and described by Roche policies, procedures and jobdescriptions.
• Be accountable forbehaviors described in Roche’s values and Leadership Competencies.
• Perform any other tasks as requested by SeniorManagement to support Quality oversight activities.

General:

• As required, serve as a Quality liaison with regulatoryagencies and external sources regarding issues impacting quality assurancemanufacturing.

Manufacturing Quality Assurance/EnvironmentalQuality Assurance:

• Represent MQA as the prime internal and external contact oncontracts and operations.
• Guide staff in supervising and integratingquality oversight into manufacturing operations.

...

The Manager / Senior Manager will support the late stage PPP team as itdelivers on a range of projects in support the late stage oncology portfolio.  Key activities forwhich PPP is responsible include:

• Portfolio Management and Reporting
• LifeCycle Team, Planning, Governance and Decision Support
• Strategic Projects at the TA Level and Cross-Portfolio
• Governance / Support for Late Stage Portfolio Committee

 

The role requires ability to providestrategic, analytical and systems support to late stage teams, TA heads, andother stakeholders in the Roche organization.

 

Responsibilities

Representative responsibilities associatedwith the role are detailed below:

 

• Portfolio Management and Reporting
• Participate on multiple lifecycle teams and ensure that portfolio reflects ongoing investments in programs
• Prepare quarterly reports on progress of portfolio and implications (incl. strategic context) for senior managers
• LifeCycle Team, Planning, Governance and Decision Support
• Consult with lifecycle teams to provide decision analysis and other analytic and strategic support
• Support development of business cases for all investments/changes, including valuations
• Facilitate annual prioritization, goal setting, lifecycle planning and business planning processes
• Advise teams on internal governance processes associated with changes/new investments
• Strategic Projects at the TA Level and Cross-Portfolio
• Support development of molecule, pathway and disease area strategies
• Frame portfolio issues and conduct gap analyses to enable management to make informed and timely decisions, including corporate goal setting and portfolio optimization
• Facilitate TA level opportunity prioritization and strategic context
• Support partnering opportunities at the TA level
• Governance / Support for Late Stage Portfolio Committee
• Work with development teams to ensure that decisions go through appropriate governance
• Advise teams and stakeholders to ensure decisions are aligned with portfolio priorities

 

Job Skills and Expectations

- A strong understanding ofpharmaceutical/biotech landscape, R&D trends, business strategy and marketsin major disease areas
- Demonstrated success in working with biotech or Pharma management and teamsin Research, Development and Commercial functions
- The ability to build cross-functional partnerships and influence withoutauthority
- Strong analytic skills and complex problem solving ability
- The ability to draw conclusions from analytics, articulate the key findingsto management and teams
- Ability to lead and facilitate cross functional teams

...

The Principal Research Associate within the Biological Technologies group in Analytical Development and Quality Control will be responsible for all aspects of automation for all phases of clinical trials utilizing precision robotics.  The Sr QC Associate will support the execution of vendor IQ, OQ/PQ documents, write and execute instrument, assay validation protocols and IQ, OQ/PQ documents.  The associate will also support the development of R&D assays onto high throughput automation platforms utilizing liquid handlers, plate readers and high content analysis instruments.  The candidate will identify and evaluate new technologies and work collaboratively with different research and development departments.  Expectations will also include writing test procedures, SOPs, protocols, technical reports, and summarizing/presenting data.  Additional responsibilities may include presentation of data at internal and external meetings, as well as reports in support of IND/BLA regulatory filings, and supporting collaborations with other groups/sites.
...

Responsibilities      

• Perform Quality review and approval of method validation and qualification reports
• Perform technical and compliance review of analytical testing results for bulk, final product, pre-clinical, cell banking and stability products
• Compile analytical data for bulk, final product, pre-clinical, cell banking and stability products
• Assess and approve discrepancies of clinical and pre-clinical products
• Review and approve COA, COT and stability statements
• Technical proficiency in analytical methodology and adherence to cGMP compliance
• Train colleagues on assay review and analytical methodology as appropriate
• Identify and implement process improvements
• Accomplish corporate, operational and departmental goals
• Exert influence in the development of objectives and long range goals of the organization
• Make independent decisions around complex issues in alignment with Roche policies
• Support internal and external audits
• Work with internal departments and outside vendors, collaborators and partners concerning projects and commitments
• Meets scheduled performance of 95% on-time
• Mentor and supervise (as required) other staff members on QC related, processes and projects.

...

Clinical Specialist
NY Metro Territory

The Clinical Specialist, Franchise Sales manages and develops long-term relationships with physicians and other customers for the customer accounts in the assigned territory in the Hospital/Critical Care setting. As such, Clinical Specialists represent the assigned GNE brand(s) and their approved indications; helping external customers such as physicians, nurses, etc. learn about the benefits of the assigned GNE brand(s) in relation to the applicable therapeutic area/disease state.

Reports to: Division Manager, Franchise Sales

Example Duties and Responsibilities:
*Responsible for meeting or exceeding assigned sales targets
*Develops robust territory business plans
*Develops strong and long-term relationships with customers in all assigned accounts
*Presents the assigned GNE brands in a professional, compliant, ethical and effective manner; helping external customers understand the benefits and use of GNE brands
*Monitors operating costs and compliance with territory budget
*Complies with all laws, regulations and policies that govern the conduct of GNE activities
*Business travel, by air or car, is regularly required

...

Purpose:

* The CMO Logistics Specialist acts as a liaison between Manufacturing Collaborations (MC), the CMOs and Genentech’s plants and logistics functions and is responsible for the detailed scheduling of orders and material movements to and from contract manufacturing sites.

* The Logistics Specialist ensures that all materials are available and delivered to the CMO on time in order to support scheduled production and releases orders to allow the CMO (through the MC Site Managers) to execute and to close orders upon completion. 

* The Logistics Specialist monitors the detailed production and shipping schedule in order to identify and resolve any variances that are occurring and coordinate required changes with the CMO. He/she also follows up to identify root causes for such variances and the corrective actions required to prevent their reoccurrence.

* The Logistics Specialist provide support to the CMO with all issues related to logistics and inventory management and provide guidance for material handling and any other questions that arise.

* The Logistics Specialist is responsible to the accuracy of inventory records and status in Genentech’s ERP system for all GNE-owned material that is at the CMO site and works with the CMO to update these records as material movements/consumptions occur.

Responsibilities:

Ensuring material availability for CMO production:

* Perform material requirements planning for multiple sites

* Monitors the detailed production schedule at assigned CMOs to identify material requirements and other preparations required to ensure readiness for production execution

* Coordinates with supplying plants to ensure alignment and understanding of CMO material requirements and shipping dates

* Ensures material availability and/or that production/delivery plans at supplying plants/warehouses are aligned with material requirement and shipping dates

* Coordinates with Quality to ensure that material release/disposition plans are aligned with required shipping dates and monitor progress of release/disposition process relative to schedule and shipping requirements

Transportation scheduling and coordination:

* Creates, converts and maintains Stock Transfer Requests (STRs) and Orders (STOs) and/or Purchase Orders for required materials

* Coordinates and/or schedule shipments with carriers and/or GNE Transportation.

* Works with GNE Transportation Import/Export functions to ensure that international shipments are properly coordinated with freight forwarders or customs agents and that materials clear customs without issues

* Coordinates with warehouse and other logistics functions to ensure that materials are prepared and shipped on time

Logistics schedule management:

* Identifies any delays during the manufacturing/release process that may have an impact on the scheduled shipping dates and works with relevant functions to avoid delays to scheduled delivery dates to CMOs

* Identifies, analyzes and escalates (to Master Scheduler or manager) schedule conflicts or delays that impact delivery dates to CMO 

* Coordinates any required changes with CMO

* Monitors the shipping/transportation of materials to/from CMO sites to ensure successful and on-time delivery.

Materials management:

* Manages and releases process orders to ensure a minimum of 7 days of orders have been released.

* Performs goods receipts of materials into CMO inventory locations upon delivery and monitors CMO inventory and material movements to ensure accuracy

* Performs regular inventor counts with each CMO and ensure updates GNE inventory records if necessary

* Allocates materials to production orders (in coordination with product planners as necessary)

* Provides guidance to CMOs and addresses questions and issues related to material handling, inventory and transportation

Performance management and projects:

* Monitors Key Performance Indicators (KPI’s) and supports root-cause analysis

* Executes all logistics process and other responsibilities in accordance with established business processes

* Identifies areas where existing business processes are not sufficiently defined/documented and/or require improvement

* Works with management to initiate improvement projects to address process deficiencies or improvement opportunities

* Collaborates with various groups and OE resources while working on cross-functional teams to support improvement projects and root cause analyses

* Takes responsibility for action items and tasks arising through such cross-functional teams and root-cause-analysis exercises and executes them to accomplish the team’s objectives 

...

Adhere to all plant safety policies and procedures and proactively identify unsafe conditions
Perform safety and housekeeping audits as required.
Assist in set up, change over, and test run equipment for various-sized vials and packages as required.
Supporting the Operations Specialist, Maintenance, and/or outside services in the repair, maintenance, and calibration of Genentech systems as required.
Perform training of other Technicians.
Assist in the development of plant SOP's and training materials
Execute production recipes, check-in equipment, and perform material movements using automated computer software applications (SAP and MES systems).
Operate all formulation, sterile filling, inspection, and final vial packaging equipment in the plant.
Perform material handling in the plant as required.
Perform preparation of sterile components.
Assist in the cleaning, set-up, sterilization, and disassembly on a variety of processing equipment.
Perform bulk thaw, dilution, and formulation operations.
Performing manual inspection of empty vials and filled product with a focus on quality and efficiency.
Conduct environmental monitoring activities in the manufacturing areas as required.
Prior to start-up, during processing, and at the completion of the manufacturing process, perform all documentation and clerical functions to provide the proper accountability and traceability of components and finished product.
At the start and finish of each shift, report and make recommendations regarding equipment, supplies, required repairs,
Process concerns, safety concerns, and areas for improvement in reliability, yield, and efficiency.
Work effectively and efficiently in a team-oriented environment to ensure maximum and high-quality output.
Perform cleaning and housekeeping duties as required....

The candidate will support the development and implementation of recombinant protein purification processes from laboratory to manufacturing scale. The work will include purification process development, optimization, characterization, and validation as well as technology development. The work includes projects carried out at laboratory, pilot plant, and industrial scale using separation unit operations including column chromatography, filtration, and centrifugation....

The candidate will support the development and implementation of recombinant protein purification processes from laboratory to manufacturing scale. The work will include purification process development, optimization, characterization, and validation as well as technology development. The work includes projects carried out at laboratory, pilot plant, and industrial scale using separation unit operations including column chromatography, filtration, and centrifugation....