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Date Job Title Job Level Location
2/23/18 Sr. / Principal (Lead) Informatics Specialist, DevSci Informatics Individual Contributor South San Francisco, California

Development Sciences Informatics is seeking a talented and experienced Informatician to lead scientific data management efforts. Development Sciences (DevSci) is a translational science organization that plays a critical role in Genentech Research and Early Development as well as late stage development of our products at Roche. DevSci supports drug discovery and development projects across all therapeutic areas from discovery to launch and beyond. We are poised at a unique time when large volumes of complex and varied internal and external data needs to be readily accessible to ensure that swift interpretation and decision making can occur. These data impact decisions in ongoing preclinical and clinical programs, and provide key knowledge to inform new target discovery. DevSci Informatics is accountable for leading the strategy and execution around data lifecycle management, data standards, analytics infrastructure, ongoing data operations and informatics systems.

Major Responsibilities:
The Lead Informatics Specialist is responsible for driving a variety of complex informatics projects and servcies to enable the storage, organization, dissemination, and analytics of dynamic data generated from innovative research and exploratory and clinical studies. This position may or may not have direct reports.

  • With thorough understanding of R&D data pipelines, establish and maintain the technical and scientific partnership with scientific functions. Communicate effectively with key stake holders and senior management.
  • Lead strategic planning and implementation of data management solutions for multiple functions to ensure data accessibility, quality, and integrity.
  • Establish standardized processes and develop tool sets for collection, transformation and visualization of large dynamic data sets. Identify opportunities and implement solutions to streamline data management work flow and to enable data analysis for DevSci functions.
  • Lead scientific business analysis and implementation of software systems aligned with DevSci scientific objectives. Evaluate systems to accommodate ongoing data management needs.
  • Work extensively with scientists and operations managers within DevSci, and collaborate frequently with clinical scientists, statisticians, and database specialists across the company.
  • Lead project teams and drive complex data management projects. Manage contract services per business needs.


 

2/23/18 QA Specialist II, MQA (HTO) Individual Contributor Hillsboro, Oregon

Please note this is a swing shift position, Tuesday through Friday 1:30pm to 1:30am (4 x 10)


Solve awide range of difficult issues that impact multiple functions, following cGMPregulations and Genentech standards 

Perform assigned tasks and work to achieve company goals and departmentobjectives.

 
Main Purpose of the Position:    
  • Provide direct manufacturing Quality Assurance support for all GMP activities at HTO/HDC.
  • Act as a key Quality contact to manufacturing for discrepancy management, batch review, and line support. 
  • Assure compliance with cGMP regulations, Roche / Genentech standards, and applicable Regulatory Guidelines.
  • Resolve routine Quality Assurance issues limited in scope and complexity following cGMP regulations and Genentech standards.
  • Perform assigned tasks and work to achieve company goals and department objectives.
 Job Duties/Responsibilities:
  • Follow company policies and procedures.
  • Maintain a state of inspection readiness.
  • Provide input to the development of personal performance goals and departmental objectives.
  • Meet assigned targets and timelines with minimal supervision.
  • Prioritize assigned tasks within a fast paced environment.
  • Participate in process improvement and system design teams.
  • Provide assistance to customers in support of departmental functions.
  • Work with colleagues to maintain cross-functional and cross-site process and procedural consistency. Provide guidance to peers as appropriate.
  • Receive specific instruction and work independently to complete tasks.
  • Apply basic theory and technical principles to address routine problems.
  • Troubleshoot and assist in the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
  • Sign documents for activities as MQA as described by Genentech policies, procedures and job descriptions.
  • Be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies.
  • Perform any other tasks as requested by Management to support Quality oversight activities.
 
Technical Duties/Responsibilities:
  • Perform Inspection and Packaging AQLs.
  • Perform Line Clearance activities in conjunction with Manufacturing.
  • Perform QAR and issue resolution to support Tank Management as needed.
  • Initiate and close discrepancies and child records as required.
  • Review batch records in the Aseptic Operations, Inspection, and Packaging areas.
  • Complete Additional Actions in the Discrepancy Management System as assigned.
  • Interact with interdepartmental contacts on discrepancy assessment and resolution.
  • Provide Quality oversight to internal and external customers.
  • Review and approve controlled documents relating to processes, equipment, facilities and utilities in the manufacture of product.
  • Collaborate with departments to ensure that all review activities are executed efficiently and effectively.
  • Support Quality process improvement initiatives.
  • Support the execution of departmental deliverables assigned by project teams.

2/23/18 Intern - Research and Early Development - Small Molecule Analytical Chemistry and Quality Control Entry Level South San Francisco, California

Start Date: Summer 2018
Length of Assignment: 12 weeks

Position 1
The position will require experience in performing liquid chromatography. We will be taking existing hydrogels, putting them into a simulated in vitro environment, and then monitoring the release profiles of specific spiked chemical compounds from a solid gel. We will be using extensive analytical instrumentation and techniques to characterize this release. They will be running analytical techniques on these simulated gel experiments and then also applying preexisting analytical principles to develop a new strategy if needed.

Position 2
This project will be focusing on the analytical characterization of a peptide therapuetic. Some stability liabilities such as deamidation and aggregation have already been identified. This project will utilize LC-MS, light scattering and other spectroscopic techniques to understand the mechanism by which deamidation might be promoting aggregation. Different variants of the lead sequence will be assessed. Additionally, Size Exclusion Chromatography was used and the deamidation product (M+1) was resolved from the desired product (M) suggesting that the corresponding hydrodynamic radii are different. Raman and Infrared spectroscopy will be used to assess the different confirmations ( a-helix, B-sheet…etc) of the two similar size molecules.

Position 3
In this research project, we're aiming to establish the VCD and NMR technology to improve the absolute configuration determination process in small molecule research. Several small chiral molecules will be used as examples to demonstrate the feasibility of VCD and NMR for AC determination. The analysis time, reliability and robustness of VCD and NMR compared to X-Ray will be evaluated as well. Absolute configuration will be determined and by both VCD and RDC/RSCAs. Comparison between these techniques and X-Ray will also be studied.

Position 4
We are looking for an Intern who is driven to use computational tools to effectively manage and mine the chromatography data to enhance quantitative decision making during chromatography method development. This individual will construct an interactive database on the chromatography data, build quantitative models to understand the compound chromatography behavior, and drive the decisions for method development. 

Position 5
The research project is focused on analysis of elemental impurities in pharmaceutical samples. Responsibilities would include learning the new instrumentation, set-up experiment design, sample preparation (of powder and liquid samples), conducting experiments, data acquisition, compilation, interpretation and presentation of data. Major characterization tools will be XRF and ICP-OES techniques. Generate calibration curve and perform spiking/ recovery studies, sample analysis. Presenting research results to department and on GNE intern poster day; organizing data for publication.
2/23/18 PHC Data Scientist - Analytics Individual Contributor South San Francisco, California

POSITION SUMMARY
As a DATA SCIENTIST within our Personalized HealthCare function you will work with meaningful data to generate impactful evidence and insights on our molecules/ medicines and patients, that support R&D, advance scientific and medical knowledge, and enable personalized patient care and access.

You will collaborate with peers within the function and across the organization to develop evidence generation strategies, identify evidence gaps and data sources, design and execute studies, and implement analyses to address molecule and disease area questions. The data will be varied in type -- patient-level clinical data, supplemented with deep patient data such as omics (e.g. genomics, proteomic), imaging, digital health, etc. Source data will be diverse -- real-world data (RWD), including patient registries, electronic medical records, claims, biobanks, and clinical trials. The evidence and insights will be used to inform the research and development of our molecules, and support healthcare decisions by patients, physicians, health authorities, payers, and policy-makers. You will also contribute to functional, cross-functional, enterprise-wide or external initiatives that shape our business and healthcare environments. This will require a good understanding of molecule and disease area strategies, healthcare environments, as well as strong scientific and technical data science expertise. You will need strong strategic, collaboration and communication skills, as well as an entrepreneurial mindset, to transform the way we use data and analytics to develop and deliver medicines for our patients.

As Data Scientist you will typically be responsible for a molecule/indication and partner with cross-functional teams and external partners with considerable independence. We have open vacanies for different roles focused on RWD, Omics and Imaging.

RESPONSIBILITIES

  • IDENTIFY EVIDENCE NEEDS & RECOMMEND DATA SOLUTIONS: Ask the right scientific questions, understand the evidence needs for research and development, regulatory and market access, and ideate and make recommendations on fit-for-purpose data and analytics solutions.
  • DEVELOP DATA STRATEGY & GAIN ACCESS TO DATA: Develop strategic plans to access fit-for-purpose data sources to support evidence generation, and gain access to data through collaboration or data generation.
  • DIVE INTO DATA: Develop a comprehensive and deep understanding of the data we work with and foster learning with colleagues using analytical tools and applications to broaden data accessibility and advance our proficiency/efficiency in understanding and using the data appropriately.
  • BE AN EXPERT IN APPLYING METHODS: Stay current with and adopt emergent analytical methodologies, tools and applications to ensure fit-for-purpose and impactful approaches. 
  • PRODUCE HIGH QUALITY ANALYSES: Apply rigor in study design and analytical methods; plan for data processing; design a fit-for-purpose analysis plan, assess effective ways of presenting and delivering the results to maximize impact and interpretability; implement and/or oversee the study, including its reporting; ensure compliance with applicable pharma industry regulations and standards.
  • INTERPRET AND SHARE RESULTS: Communicate findings to internal stakeholders, regulatory, health technology assessment (HTA) bodies and scientific communities; publish results; participate in external meetings and forums to present your insights (e.g. congress/conference).
  • COLLABORATE & SHAPE: Collaborate and contribute to functional, cross-functional, enterprise-wide or external data science communities, networks, collaboratives, initiatives or goals on knowledge-sharing, methodologies, innovations, technology, IT infrastructure, policy-shaping, processes, etc. to enable broader and more effective use of data and analytics to support business.

2/23/18 Senior Strategy Realization Manager - Site Services Individual Contributor South San Francisco, California

The Senior Strategy Realization Manager will be responsible for successfully implementing and sustaining the Site Services strategy through the following three elements:
  1. Ensuring alignment of strategy, goals, and metrics
  2. Creating a comprehensive and effective communication strategy

1. Aligning strategy, goals, and metrics:
This person will be required to establish and implement a departmental-wide process that aligns Site Services strategic pillars and innovative vision to project, departmental and individual activity. The ultimate goal is to enable organizations to effectively translate strategic intent all the way through to results in a clear and powerful process. This will require significant indirect influencing skills in order to align the departments’ goals and metrics to the Site Services goals, and ultimately, implementing Site Services strategy throughout the rest of the organization. This person will lead the strategy setting process through engaging with and influencing the Site Services Leadership Team.

  1. 2. Creating a comprehensive communication strategy:
This person will drive the improvement of an effective and comprehensive internal and external communication strategy for the Site Services organization. This includes responsibility for communicating the strategic direction of Site Services and the Site Services strategic pillars as well as the Innovation lab output. 

This position will also focus on leading the team that develops and executes communications strategies and plans for Site Services projects and programs, including writing, editing, and publishing a broad range of electronic and print materials to inform and engage Site Services employees, including announcements, presentations, briefing notes, etc. This person will be expected to partner effectively with Genentech Corporate Relations to ensure alignment of the Site Services narrative, communications, and strategy to the broader Genentech Corporate Relations internal and external communications strategy and to provide appropriate Site Services content for use through corporate channels (intranet, internet, social media, etc.). This person will be responsible for partnering with the VP of Site Services and SSLT members to develop executive-level presentations (board-level, CEC, gEC). 

This person will also be responsible for including change management tools into the Site Services communication processes to ensure projects are successful by increasing employee adoption and usage. Additionally, through communication, this person will engage with leaders to ensure successful change management of Site Services service level changes across the broad employee base. He/She will need to create and implement communication and change management strategies and plans that maximize employee adoption and usage and minimize resistance. 

This person will be the point of contact for Site Services crisis management communications for internal Site Services employees and will work with Corporate Relations to drive appropriate responses.

This position will report to the Director of Site Services Strategy and Business Operations. This is a significant consultative role and hands-on position for an individual who wants to influence the work of others and contribute directly to the employee engagement strategy of Site Services. This person will also manage 3-5 green badge/blue badge employees. 

Major Responsibilities:

  1. Aligning strategy, goals, and metrics:
  • Create communication strategy and plan to ensure alignment amongst departments with the Site Services vision, strategy, and goals. Ensure alignment with campus vision and experience workstreams (including scenarios).
  • Lead the annual vision and strategy updates with the Site Services Leadership Team.
  • Create awareness and engage SS community in building strategy.
  • Measure strategy success and assess adoption and “stickiness”.
  • Partner with Strategy and Business Operations peers to optimize the Site Services Quarterly Operations Review by creating appropriate metrics that aligns to goals and strategy.
  • Support the development, monitoring, analysis and reporting of critical metrics for internal communications channels and projects to develop actionable insights for continuous improvement.

  1. Creating a comprehensive communication strategy:
  • Create Site Services communications strategy and plan ensuring effective and timely communication across the departments to breakdown silos and create alignment on current issues. 
  • Lead the Communications team by managing work activities and balancing work load across an extremely fluid and ambiguous work environment.
  • Ensure consistency of internal messaging throughout Site Services, both in writing and design, while allowing individual “voices” to come through 
  • Create, implement, and maintain Site Services narrative.
  • Develop standard tools (website, e-mail templates) for Site Services employees using Genentech corporate approved guidelines and toolkits.
  • Partner with SSLT members to design and deliver all employee meetings that are engaging and interactive.  Coach leaders to be more effective storytellers and communicators.
  • Ensure communications strategies support our desire to build a collaborative and inclusive community.
  • Own People Forum communication strategy and tactics
  • Partner with other members of Site Services to determine and deploy the best communication tools - video, print, graphics, etc. - and strategies to provide different employee groups with the information they need in a format that’s easy to find and use.
  • Perform technical editing or writing assignments, as needed.
  • Simplify complex messages while collaborating closely with one or more authors to ensure employees can easily and quickly understand the content.
  • Apply a structured change management methodology to all employee impacting communication plans
  • Own the design, development, delivery and management of communications.
  • Conduct impact analyses, assess change readiness and identify key stakeholders on communication strategies.
  • Identify and manage anticipated resistance to communication plans
  • Consult and coach project teams on change impact to employees
  • Support Site Services leadership and project teams to strategically communicate new policy developments, procedures, and/or business systems to relevant stakeholders in a timely and customized fashion. Create multiple opportunities for employees to engage with the senior leadership team so that they feel valued and heard.
  • Partner with Corporate Relations on new communications standards, channels and metrics to improve performance. 
  • Manage a team of 3-5 green badge/blue badge employees specializing in website, graphics/video, and newsletter communication in line with Genentech corporate approved guidelines and toolkits.

2/23/18 Statistical Scientist Individual Contributor South San Francisco, California

The Statistical Scientist is responsible for providing high-quality statistical expertise to assigned Clinical Development studies or nonclinical projects. He/she looks beyond the purely statistical aspects, collaborating actively to promote rigor in the planning, conduct, and analysis of experiments, and in the interpretation of results. He/she operates with minimal supervision at the study level, receiving guidance from the project level statistician to ensure alignment. 


In the clinical study setting the Statistical Scientist works closely with study team partners from biometrics, clinical science, safety science, operations, pharmacology, and regulatory. They collaborate to create of strategies to address drug development needs and design and execute appropriate studies. This includes input to protocols, review of case report forms, developing data analysis plans, and supporting the execution and interpretation of planned analyses. Effective collaboration with Operations, Data Management, and Statistical Programming personnel is essential. 


Beyond study level contributions, the Statistical Scientist may also take ownership of early development projects or significant components of late-stage projects (e.g., serving as a submission team leader or setting up project level data monitoring committees). These project level responsibilities will typically be accomplished with guidance from management and more senior statisticians. 


Key Responsibilities & Accountabilities 


Clinical Development: 

  • Member of clinical team, collaborating in preparation of Clinical Development Plans and target product profiles; typically lead statistician on cross-functional study management teams or sole statistician on early development project teams 
  • Study Planning: Reviews study protocols, authors statistical sections of protocols, prepares the study randomization, develops the statistical and data analysis plans, develops independent data monitoring and endpoint committee charters. 
  • Study Conduct: Reviews case report forms to ensure protocol objectives are met and project standards are maintained. Develops statistical programs as necessary to perform analyses, review and approve analyses produced by statistical programming 
  • Analysis & Reporting: Authors the clinical study report, provides input into global health authority documents and regulatory response for health authority submissions. Contributes to study publications and presentations. Provides analytical and strategic leadership for exploratory activities such as personalized healthcare biomarker development and PK/PD modelling.
  • Oversees the deliverables from Statistical CROs. 
  • Leads cross-functional teams in overseeing the generation of health authority submission datasets and associated documentation 
  • Participates in health authority meetings 
Nonclinical Statistics: 

  • Study Planning: Provides experimental design and analysis strategies to nonclinical projects. 
  • Analysis and Reporting: Performs statistical analyses for nonclinical studies, provides input to IND and BLA submissions and to regulatory response to global health authority investigations related to marketed products, and contributes to publications and presentations. 
  • Statistical Consulting: Provides statistical advice to nonclinical investigators and contributes to the development of statistics courses. 
Functional Area: 

  • Understand and apply business requirements and processes. Participates in functional training. 
  • Keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review, conference attendance, etc. 
  • Participates in Biostatistics and cross-functional initiatives. Participates in the development of functional processes 
  • Recognized expertise in clinical trials and statistical methodology for a clinical indication and/or statistical methodology for specialized applications. 
People Development and Management: Mentor other statisticians on request

2/23/18 Senior/Medical Science Director, Rare Diseases USMA Individual Contributor South San Francisco, California

On behalf of Roche/Genentech, the USMA Spectrum MU develops strategies for engagement in scientific and strategic discussions and collaborations with diverse external stakeholder entities across the many new therapeutic areas covered by Spectrum. The Scientific Collaborations group is accountable for leading and managing Genentech’s relationships with these aforementioned organizations and facilitates strategic and scientific discussions and decisions across key stakeholders. This group is also responsible for leading the Scientific Congress planning for major scientific meetings that span Neuroscience/Neurology , Hemophilia and our developing pipeline in Rare Diseases (in collaboration with GMA, gRED, pRED, and PD organizations). 



Responsibilities: 
As a Medical Science Director in Scientific Collaborations, your areas of major responsibility include, but are not limited to the following:

  • Develop and execute overall strategy to facilitate Genentech’s relationships with US-based external entities (eg. medical societies, multi-center research and care organizations, patient advocacy groups) in specifically assigned rare diseases 
  • Engaging in strategic and scientific discussions with key stakeholders as well as within Genentech/Roche.
  • Leading cross-functional, long term projects and collaborations with these organizations which requires multiple internal stakeholder alignment (ie – HEOR, clin ops, legal, medical director(s), early development, government affairs, patient advocacy, marketing).
  • Maintaining an active role on the relevant USMA medical teams to provide strategic insight and execution of medical team strategies.
  • Gain and demonstrate scientific knowledge and expertise within rare disease areas of focus to ensure proposals and concepts are clearly communicated to GNE medical teams and Spectrum leadership
  • Lead and manage Scientific Congress strategy and planning efforts, working closely with assigned vendors, for major scientific meetings in Spectrum.
  • Development and coordination of TAE engagement plans which includes planning and executing visiting professorships on campus.
  • Collaborating across the organization representing USMA Spectrum on multiple work streams and task forces
  • Development of long-term strategic partnerships with thought leaders, external stakeholders, as well as within Genentech/Roche across USMA, GMA, Commercial, PD, gRED, pRED and others.
  • Act as a guardian for high standards of compliance, ethics and safety; putting patients at the center of all actions.
2/23/18 Sr Automation Engineer - Vacaville Individual Contributor South San Francisco, California

This position is for Sr. Automation Engineer reporting into the CCP2 (Cell Culture Plant 2) Process Automation CSE (Control System Engineering) group within the Manufacturing Sciences and Technology (MSAT) department.
 
Process Automation CSE group is responsible for maintaining existing MCS that comprises of POMSNet and Experion PKS system in compliance state as well as implementing new automation solutions. Major milestones of CCP2 Automation roadmap include upgrading existing Honeywell MCS, design and build new DeltaV based solution and migration of standalone PLC based systems to SCADA systems.
 
The Sr. Engineer will provide automation support on capital projects and implement changes/ improvements on automation systems in biopharmaceutical manufacturing operations as part of the Vacaville manufacturing plant. Major areas in CCP2 plant includes Media preparation, Fermentation, Centrifugation, Column chromatography, Buffer preparation, TFF operations, and filtration/freeze operations.
 
The Sr. Engineer will be responsible for working with vendor on design, build, implementation and validation of DeltaV based automation system. He/she will be part of a team that provides 24/7 technical support for make, asses, and release activities and capital project execution.  The candidate must be a self-starter who can independently drive projects and day-to-day work tasks to completion according to schedule and must be able to work well with others as a team member in an informal results oriented environment.
 
Responsibilities:
The candidate will provide technical leadership and support of the CCP2 Distributed Control System includes but is not limited to the following:  
  • Automation design and support to the manufacturing DCS using the following applications as well as providing leadership in the implementation of automation changes.
    • DeltaV, DeltaV Batch and Syncade
    • Honeywell MCS system (Experion PKS and Total Plant Batch applications) and POMS  is a PLUS
  • Troubleshooting of process, equipment, and system malfunctions or failures involving the DCS/MCS system, including after hours on-call support.  Initiate immediate corrective or preventative actions to ensure continued compliant operation including emergency change records as needed.
  • Provide technical assessments and evaluations for discrepancies that occur during manufacturing operations, as well as provide technical input for investigation and/or developing and implementing corrective action plans.
  • Redline automation functional specifications for automation lead review/approval, troubleshoot the DCS/MCS system and software, prepare automation change record forms and perform off-line and on-line coding and testing.
  • Support and lead Automation projects with activities such as detailed design, design review, implementation, testing/debug, and troubleshooting and project management.
  • Work with Manufacturing, Quality, Facilities, and MSAT departments to implement continuous improvement changes as well as capital projects ranging from product technology transfers, to DCS migrations.
  • Clearly communicate across functional departments at various levels to drive efficient issue resolution and change implementation.
2/22/18 Training Systems Specialist Individual Contributor South San Francisco, California

Relocation is not designatedfor this position.


Job Purpose:

  • Provides global training service and operational systems support together for all Pharma Development Quality (PDQ) supported business functions (gRED, pRED, PD, GPS and affiliates) for all relevant Clinical & Pharmacovigilance regulatory compliance training.
  • To ensure appropriate rollout of GxP training plans in the global learning management systems, training communications and training operations.
  • To contribute to the reporting and analysis of training compliance metrics within PDQ and the supported business functions, including affiliates, and follow-up where required
Primary Responsibilities and Accountabilities:
  • Contributes to the execution of the training operations plan and strategy
  • Supports the test, upload, deployment of training programs required as part of the Quality Management System
  • Acts as the Training System Specialist responsible for the end to end process and works closely with the Standard Operating Procedures (SOP) and Learning Solutions group in PDQS to ensure timely planning and execution of the training roll-out plan for procedural documents.
  • Oversees the administration of global and local training programs within the Learning Management Systems, maintains and updates role-based training curricula, and delivery of training compliance reports in accordance with defined processes.
  • Leads Training System projects by incorporating concepts of Project Management Methodology (PMM)
  • Collaborates with key business stakeholders to help ensure that global, functional and local training grids are accurate and current
  • Performs quality checks on all training assignments, training deployments, metrics reporting and communication provided on behalf of PDQS Training Systems & Operations Group
  • Communicates the training requirements to business stakeholders including completion timelines, curricula requirements for existing employees and new hires, in addition to providing status updates on all inquiries through the use of all available communication channels.
  • Proficient technical and business expertise for all IT tools required to support the administration of the PDQ Training Quality System in a compliant and efficient manner and integrated training evaluation methodologies that measures training effectiveness.
  • Provides Tier 1 customer service support and ensures issues (e.g., user requests, change control) are resolved in a timely manner.
  • Generates innovative ideas and/or investigate potential methods in streamline workflow processes
  • Ensures that business partner expectations for training operations and deployment are met.
  • Contributes to the PDQS Training Systems & Operations & PDQS Learning Solutions Teams to set strategies and achieve the long-term goals & objectives for PDQS and PDQ as a whole.
  • Well versed in all services and activities provided by PDQS Training Systems & Operations, PDQS Learning Solutions, and PDQ in order to provide business stakeholders with a comprehensive overview and effectively communicates how their training needs can be met.
  • Provides training and knowledge sharing sessions to peers and to functional and affiliate Training experts


2/22/18 Assistant / Associate Medical Director, Cancer Immunotherapy - Combination Studies Individual Contributor South San Francisco, California

Description:
As an Assistant or Associate Medical Director you will:

  • Participate in Clinical Development strategy development and present to various internal committees
  • Provide clinical oversight across all relevant studies and programs
  • Lead and/or otherwise participate in ongoing clinical study team and relevant sub-team meetings, other interactions and communications
  • Work with regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation. Support others with clinical science information and input for regulatory submissions and other regulatory processes. Includes developing labeling and packaging language, etc.
  • Play a role in the development and implementation of communication strategies to support existing and concluded studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials
  • Contribute clinical science input into the relevant therapeutic/disease area scientific strategy. Help research and other Product Development groups to ensure consistency of scientific and late-development strategies with target label claims and corporate goals
  • Collaborate with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and key opinion leaders (KOLs), as well as multidisciplinary internal groups, including other groups in Product Development, research, business development, commercial operations, legal, etc.


2/22/18 Medical Science Liaison, Gastroimmunology (TN, MS, AL, KY, GA, SC, FL, PR) Individual Contributor Texas

In this position, you will be primarily accountable for consistently, effectively:  


  • Representing the assigned molecules/products, franchise(s) and overall therapeutic area(s) to the highest ethical and professional standards and in accordance with guidelines, direction and key marketing strategies
  • Responding to on- and off-label questions with the highest integrity, compliance and adherence to legal, regulatory and Genentech guidelines, policies & procedures
  • Building and cultivating important working relationships internally and externally Providing clinical expertise and feedback regarding operational management that effectively and efficiently guides clinical trials, other studies and investigations Providing clinical expertise in the development, management and maintenance of clinical and scientific communications, including research, publications, and educational materials, meeting/event presentations and information, etc.
  • Actively and effectively participating in various internal and external clinical and scientific education programs, meetings, presentations and other forums; providing in-depth clinical and operational expertise and insights regarding the assigned molecules/products, franchise(s), and overall therapeutic area(s)
  • When assigned, identifying and completing special projects
  • Ensuring assigned goals and objectives are met and that assigned projects and other work are completed on time, to high standards and within budget 


Strategy/Planning:

Work with manager, peers, other partners and stakeholders in the development and alignment of medical plan tactics at the regional and local MSL levels: 

  • Participating in a variety of cross-functional tactical planning meetings, reviews and discussions
  • As assigned, supporting your manager, medical directors, and other peers in gathering information, analyses, research and reporting to support national, regional, and local tactical planning
  • With assistance from your manager, using national and regional medical plans for the assigned molecules/products to develop and align the tactical plan for your geography of responsibility
  • Providing input to manager regarding travel, budget and other resource requirements to meet or exceed assigned goals and objectives
  • Build and cultivate relationships with internal cross-functional partners, such as Franchise Sales, Franchise Marketing, Managed Care & Customer Operations, Thought Leader Services, Pharmaceutical Research and Early Development, Product Development, Clinical Operations, Commercial Operations and other Medical Affairs groups
  • Build and cultivate relationships with the local scientific and medical communities, including study site clinical research staff, clinical investigators, physicians, other healthcare professionals, as well as regional thought leaders 


Operations:

  • As appropriate, support design and development of clinical trials, other studies and investigations
  • Support Clinical Operations with Phase III studies, by providing clinical support at investigator sites
  • Evaluate, review and propose, when and where appropriate, revisions to protocols in support of the development and/or medical strategies of the assigned product(s). As and when approved, undertake the necessary revisions to protocols, ensuring full compliance with all established procedures and guidelines, as well as appropriate communication to other involved/impacted colleagues and/or external parties
  • Work with a host of cross-functional partners to develop plans and tactics for implementation and completion of clinical trials, studies and other investigations. Includes plans for developing and recruiting for patient registries, clinical and scientific communications, publications, clinical and scientific education, advisory boards, clinical and scientific congresses, other conferences and meetings, etc. 
  • Work with Medical Communications and Publication Planning to develop, disseminate and manage calendars and timelines for clinical and scientific communications, publication plans and other relevant research, data, information and communications for assigned molecules/products 


Communication/Other:
  • Maintain the highest standards and levels of scientific, clinical and technical expertise in the specific therapeutic area(s) of assignment; reviewing and keeping updated on scientific/medical journals and other relevant publications, attending scientific, clinical, commercial and other key meetings, forums, venues, etc., as well as continuous communication and effective partnering with various Genentech and Roche groups
  • As assigned, complete special projects  
2/22/18 Senior/ Medical Science Liaison, Gastroimmunology (TX, NM, UT, AZ, AR, OK, LA, CO) Individual Contributor Texas

In this position, you will be primarily accountable for consistently, effectively:


  • Representing the assigned molecules/products, franchise(s) and overall therapeutic area(s) to the highest ethical andprofessional standards and in accordance with guidelines, direction and key marketing strategies
  • Responding to on- and off-label questions with the highest integrity, compliance and adherence to legal, regulatory andGenentech guidelines, policies & procedures
  • Building and cultivating important working relationships internally and externally Providing clinical expertise and feedbackregarding operational management that effectively and efficiently guides clinical trials, other studies and investigationsProviding clinical expertise in the development, management and maintenance of clinical and scientific communications,including research, publications, and educational materials, meeting/event presentations and information, etc.
  • Actively and effectively participating in various internal and external clinical and scientific education programs, meetings,presentations and other forums; providing in-depth clinical and operational expertise and insights regarding the assignedmolecules/products, franchise(s), and overall therapeutic area(s)
  • When assigned, identifying and completing special projects
  • Ensuring assigned goals and objectives are met and that assigned projects and other work are completed on time, tohigh standards and within budget 
 
Strategy/Planning:

Work with manager, peers, other partners and stakeholders in the development and alignment of medical plan tactics atthe regional and local MSL levels:  

  • Participating in a variety of cross-functional tactical planning meetings, reviews and discussions
  • As assigned, supporting your manager, medical directors, and other peers in gathering information, analyses, researchand reporting to support national, regional, and local tactical planning
  • With assistance from your manager, using national and regional medical plans for the assigned molecules/products todevelop and align the tactical plan for your geography of responsibility
  • Providing input to manager regarding travel, budget and other resource requirements to meet or exceed assigned goalsand objectives
  • Build and cultivate relationships with internal cross-functional partners, such as Franchise Sales, Franchise Marketing,Managed Care & Customer Operations, Thought Leader Services, Pharmaceutical Research and Early Development,Product Development, Clinical Operations, Commercial Operations and other Medical Affairs groups
  • Build and cultivate relationships with the local scientific and medical communities, including study site clinical researchstaff, clinical investigators, physicians, other healthcare professionals, as well as regional thought leaders 

Operations:

  • As appropriate, support design and development of clinical trials, other studies and investigations
  • Support Clinical Operations with Phase III studies, by providing clinical support at investigator sites
  • Evaluate, review and propose, when and where appropriate, revisions to protocols in support of the development and/or medical strategies of the assigned product(s). As and when approved, undertake the necessary revisions to protocols,ensuring full compliance with all established procedures and guidelines, as well as appropriate communication to otherinvolved/impacted colleagues and/or external parties
  • Work with a host of cross-functional partners to develop plans and tactics for implementation and completion ofclinical trials, studies and other investigations. Includes plans for developing and recruiting for patient registries, clinicaland scientific communications, publications, clinical and scientific education, advisory boards, clinical and scientificcongresses, other conferences and meetings, etc.
  • Work with Medical Communications and Publication Planning to develop, disseminate and manage calendars andtimelines for clinical and scientific communications, publication plans and other relevant research, data, information andcommunications for assigned molecules/products 

Communication/Other:

  • Maintain the highest standards and levels of scientific, clinical and technical expertise in the specific therapeutic area(s)of assignment; reviewing and keeping updated on scientific/medical journals and other relevant publications, attendingscientific, clinical, commercial and other key meetings, forums, venues, etc., as well as continuous communication andeffective partnering with various Genentech and Roche groups
  • As assigned, complete special projects
2/22/18 Senior/ Medical Science Liaison - Hematology, Mid Atlantic (MD, DE, D.C, VA, WV, NJ) Individual Contributor Washington, District of Columbia

Territory Area: Mid Atlantic (MD, DE, D.C., VA, WV, NJ) 


Key Accountabilities 
In this position, you will be primarily accountable for effectively:

  • Representing the assigned molecules/products, franchise(s) and overall therapeutic area(s) to the highest ethical and professional standards and in accordance with guidelines and direction.
  • Responding to on and off-label questions with integrity, compliance, and adherence to legal, regulatory, and Genentech guidelines, policies & procedures.
  • Building and cultivating important working relationships internally and externally.
  • Providing clinical expertise and feedback regarding operational management that effectively and efficiently guides clinical trials, other studies and investigations.
  • Providing clinical expertise in the development, management, and maintenance of clinical and scientific communications, including research, publications, and educational materials, meeting/event presentations and information, etc. 
  • Participating in various internal and external clinical and scientific education programs, meetings, presentations and other forums; providing in-depth clinical and operational expertise and insights regarding the assigned molecules, products and overall therapeutic area(s).
  • When assigned, identifying and completing special projects.
  • Ensuring assigned goals and objectives are met and that assigned projects and other work are completed on time, with high quality, and within budget. 

Example ResponsibilitiesIn this position, you will:

  • Participate in a variety of cross-functional meetings and discussions.
  • Support your manager, medical directors, and peers in gathering information, analyses, research and reporting to support national, regional, and local tactical planning.
  • With assistance from your manager, use national and regional medical plans for the assigned molecules, products, develop and align the tactical plan for your geography of responsibility.
  • Build and cultivate relationships with cross-functional partners, such as franchise sales, marketing, Managed Care, Clinical Operations, Thought Leader Services, Pharmaceutical and Genentech Research and Early Development, Product Development, and various Medical Affairs groups.
  • Build and cultivate relationships with local scientific and medical communities, including study site clinical research staff, clinical investigators, physicians, and other healthcare professionals.
  • As directed, support clinical goals related to investigator-initiated and company sponsored research.
  • Work with a variety of cross-functional partners to discuss plans for implementation and completion of clinical trials. 

Communication/Other

  • Maintain the highest standards and levels of scientific, clinical and technical expertise in the specific therapeutic area(s) of assignment
  • In collaboration with Scientific Collaboration, attend and lead scientificmeetings, forums, venues, etc.
  • As assigned, complete special projects
2/22/18 Senior/ Medical Science Liaison, Hematology (South: MO, AR, LA, MS, AL, TN) Individual Contributor Tennessee

Territory Area: South (MO, AR, LA, MS, AL, TN) 


Key AccountabilitiesIn this position, you will be primarily accountable for effectively:

  • Representing the assigned molecules/products, franchise(s) and overall therapeutic area(s) to the highest ethical and professional standards and in accordance with guidelines and direction.
  • Responding to on and off-label questions with integrity, compliance, and adherence to legal, regulatory, and Genentech guidelines, policies & procedures.
  • Building and cultivating important working relationships internally and externally.
  • Providing clinical expertise and feedback regarding operational management that effectively and efficiently guides clinical trials, other studies and investigations.
  • Providing clinical expertise in the development, management, and maintenance of clinical and scientific communications, including research, publications, and educational materials, meeting/event presentations and information, etc.
  • Participating in various internal and external clinical and scientific education programs, meetings, presentations and other forums; providing in-depth clinical and operational expertise and insights regarding the assigned molecules, products and overall therapeutic area(s).
  • When assigned, identifying and completing special projects.
  • Ensuring assigned goals and objectives are met and that assigned projects and other work are completed on time, with high quality, and within budget. 

Example Responsibilities 

In this position, you will:
  • Participate in a variety of cross-functional meetings and discussions.
  • Support your manager, medical directors, and peers in gathering information, analyses, research and reporting to support national, regional, and local tactical planning.
  • With assistance from your manager, use national and regional medical plans for the assigned molecules, products, develop and align the tactical plan for your geography of responsibility.
  • Build and cultivate relationships with cross-functional partners, such as franchise sales, marketing, Managed Care, Clinical Operations, Thought Leader Services, Pharmaceutical and Genentech Research and Early Development, Product Development, and various Medical Affairs groups.
  • Build and cultivate relationships with local scientific and medical communities, including study site clinical research staff, clinical investigators, physicians, and other healthcare professionals.
  • As directed, support clinical goals related to investigator-initiated and company sponsored research.
  • Work with a variety of cross-functional partners to discuss plans for implementation and completion of clinical trials. 

Communication/Other 
  • Maintain the highest standards and levels of scientific, clinical and technical expertise in the specific therapeutic area(s) of assignment
  • In collaboration with Scientific Collaboration, attend and lead scientificmeetings, forums, venues, etc.
  • As assigned, complete special projects
2/22/18 Associate Director, HR Business Partner, PT (Vacaville) Manager South San Francisco, California

Key Position Responsibilities:
? The AD will develop and drive business strategy by applying broad functional knowledge, skills and solid judgment, and significantly influencing the overall objectives and long-range goals of the Vacaville site. This person will possess a full range of proficiency and experience in the following areas of: Workforce Planning, Recruitment, Performance Management, Compensation, Organizational Development, Coaching/Consultation, Talent Management, Succession Planning, Change Management, Project/Program Management and leadership for a team of direct reports.? The AD will apply strong technical expertise, knowledge of the business and environment, and situation specific analysis to develop and implement new concepts, techniques, and standards to address organizational and people-related challenges across the Vacaville site
? The AD will understand how various organizational dynamics may affect   the overall performance of the business.
? The AD will provide consultation to the organization on strategic projects and goals as they relate to the effectiveness of the Vacaville site, influencing cross-functional business activities/initiatives where appropriate.
? The AD will successfully plan, prioritize, and lead complex work assignments.
? The AD will be accountable for creating people strategies and assigning resources across the organization ensuring coordination, prioritization and deployment of integrated solutions to support the site’s objectives and goals.
? Build, lead and manage a high-trust, highly-aligned team of Human Resource
Managers with clear goals and priorities that will support the site’s business needs.
? Determine most efficient and effective way to deliver services considering costs,
ratios and appropriate Key Performance Indicators, partnering with service
organizations where possible.
? As a key member of the Vacaville Leadership Team, influence and collaborate with colleagues to create, continuously evaluate and ensure strategic Human Resources support aligned with business objectives and is consistent with DS, PT and company values and culture, and in compliance with laws and regulations.
2/22/18 Intern - Corporate Groups - Site Services, EHS Entry Level South San Francisco, California

The Environmental, Healthy and Safety (EHS) department in SSF is responsible for all environmental or health and safety related issues occurring in SSF and Dixon.  The EHS group is split into Safety, Occupational Hygiene, Environmental, Health @ Work, and Sustainability. Within EHS, several software solutions are utilized to meet the diverse needs of the group.


Intern Position within EHS


This role would report directly to the EHS Senior Business Systems Analyst. The Senior BSA is responsible for coordinating all software related projects and day-to-day maintenance of existing software solutions. The internship would involve handling various requests from EHS personnel including running reports, extracting data, and other ad-hoc requests. Additionally, the intern would assist the BSA in the roll-out of new software solutions including documenting requirements and engaging stakeholders. The intern should possess a strong command of Excel (pivot tables, macros, etc.), database knowledge, and some experience with coding or scripting. While no detailed coding is required from this role, intern should be proficient in basic Google Apps Scripts.


Responsibilities

  • Address scripting needs for google sheets, forms, scripts, etc.
  • Assist with the development of various Tableau dashboards for the EHS group
  • Run standard reports needed for the EHS group including training reports (SAP) and payroll hours
  • Attend meetings relevant to long term projects regarding future software solutions for the department
2/21/18 Intern - Corporate Groups, Commerical - Training and Development Entry Level South San Francisco, California

U.S. Commercial, Medical, and Government Affairs Training & Development (CMG T&D) is committed to aligning core competencies to our training offerings. The programs we offer are designed and implemented with a focus on the Complete Training Experience, a framework that links training and development efforts to business results. This approach enables each CMG employee to effectively acquire and utilize knowledge and skill at the right time in his/her professional development to achieve optimal performance.  


Responsibilities


1. Review work with internal and external partners to update existing electronic training modules (eLearnings) by:

  1. Identifying outdated information 
  2. Refreshing content and improving the quality of the information
  3. Building in measurement

2. Determine which courses need to be updated or if new courses should be created

  1. Update and create eLearning content that utilizes adult learning principles, instructional design methods, software, and tools to incorporate interactivity, gaming, and other learner engagement tactics

3. Collaborate with our internal partners to publish the training 


4. Collaborate with internal and external partners to ensure content accuracy 


5. Collaborate with external vendors to develop training


6. Assist with creation of pull-through efforts

2/21/18 Intern - Product Development - PHC Business Operations Entry Level South San Francisco, California

Start Date: Summer 2018

Length of Assignment: 12 weeks (with potential for extension)

Genentech is seeking an intern pursuing a MSc/PhD degree with expertise in transformation operational/business data into insights for management to take action.   You will be joining the Personalized Healthcare (PHC) Business Operations team and will have the opportunity to understand how our function operates from real world data research ideation to generation and sharing of scientific evidence/insights.  Collaborating with all member of our Business Operations team,  you will be asked to develop an operational dashboard/portal applying  your  business analysis skillsets, programming/analytic tool knowledge and design-thinking.


We are looking for individuals who are:

  • Creative problem solvers, quick learners and comfortable experimenting with new approaches

  • Dive deep into large-scale data to uncover trends and identify key insights that will propel business strategy.

  • Demonstrate high productivity and enjoys dealing with ambiguity and applying novel methodologies

  • Possess entrepreneurship, passion and curiosity for understanding and interrogating data.


Responsibilities:

  • DIVE INTO DATA: Design, protoype, build data visualization applications to portray the data insights intuitively for management review/action using technologies such as Rails, node, Python, Java, JavaScript, HTML5, CSS3.  Data analytics & visualization front-end experience a bonus (D3.js, HighCharts, Plotly, etc.)

  • INTERPRET AND SHARE RESULTS: Proactively share learnings and knowledge and help shape the direction for Business Operations by identifying areas requiring Business Operations improvement projects (based on data insights) .  Create dashboards to facilitate timely identification of significant changes to KPIs.

  • COLLABORATE: Collaborate with the PHC Data Science team and Business Operations colleagues to understand data sources, what the data represents and gathering requirements on decisions we can make using the data.  Partner with the Analytics team to leverage tools, platforms, standards and better practices.  Create analytical frameworks to measure team success: partner with cross-functional teams to define success metrics, create approaches to track the data and troubleshoot errors, quantify and evaluate the data, then develop a common language for all colleagues to understand these KPIs

  • PRODUCE HIGH QUALITY ANALYSES: Determine how to improve the quality of the data (error/trend-spotting, correlations, etc.) .  Support data processes - provide the team with ad-hoc analysis, automated dashboards, and self-service reporting tools.

2/21/18 Senior Director Regulatory Policy US Manager with Direct Reports Washington, District of Columbia

Level:  D3

Location:  Washington, DC

 

Responsibilities:

• Leadership, oversight and execution of all Roche`s Pharma CMC regulatory policy activities including the development of Roche global policy positions on key topics relevant to Pharma Technical, and effective advocacy of such positions externally.  While the position will have primary focus on US related Policy activities, strong partnership and engagement with international forums to enable global regulatory convergence is expected.

• The role is impact-critical to the company; having strategic involvement with company-wide implications.

• The incumbent will be accountable for long-term strategic and operational goals.

• We expect the position holder to represent Roche with influence and professionalism.

Job Description:

• Lead CMC regulatory policy activities with initial focus on US such that Roche is recognized as an industry leader with health authority agencies and industry peer groups and that significant value is realized in facilitating pipeline development, marketing authorizations and excellence in manufacturing; (i.e., shape the global regulatory environment facilitating the execution of Roche strategies and businesses)

• Partner effectively with US Government Affairs and Development Regulatory Policy to facilitate Genentech`s/Roche`s strategies in the US

• Develop and execute a strategic plan for regulatory innovation to advocate for implementation of new regulatory pathways enabling early access to medicines and use of innovative technologies in process development and commercial manufacturing and controls.

• Influence external regulatory bodies on behalf of Roche

• Partner effectively and advise internal teams on optimized regulatory strategies for development and commercial products, ensuring sound regulatory and science based approaches.

• Build and maintain relationships based on trust and respect with key health authority professionals, relevant academic and opinion leaders and non-profit scientific associations

• Provide leadership in key regional and international committees and governmental/trade organizations engaged in policy decisions and global regulatory guidance development (e.g., ICH, WHO, PANDRH, BIO...)

• Lead (directly) external scientific task forces and effectively engage with senior industry and government policy makers and international committees of importance to Roche priorities

• Gather, assess and timely communicate regulatory intelligence and relevant changes in the evolving regulatory environment to key stakeholders (PTR-LT and relevant PT functional leadership teams), as well as ensure the coordination of global PT commenting on relevant regulatory guidance’s

• Develop networks, partnerships and common ways of working with relevant internal key stakeholders specifically policy groups from other functions (including PD, GPS, commercial regions) to foster cross-functional collaboration and alignment achieving common goals of high relevance for the Roche business.

• Impact on Pharma goals through successful actions (e.g. Regulatory simplification in  Industry)

• Acts as mentor and advisor to the Manufacturing- and Quality Site Heads and key members of their leadership teams regarding best practices, key opportunities and threats to ensure Roche continues excellent positioning in the area of Regulatory.

2/21/18 Intern - Research and Early Development - Early Discovery Biochemistry Entry Level South San Francisco, California

Start Date: Summer 2018
Length of Assignment: 12 weeks

The Early Discovery Biochemistry Department combines biochemical, chemical, structural, and combinatorial approaches to explore protein functions and molecular interactions, with the primary goal of assessing the tractability of non-standard novel targets. In addition, we support Research pipeline projects by providing biochemistry and biophysics expertise and resources.

Position 1
We are looking for a chemistry focused summer Intern to work in the chemical biology lab. The candidate will perform chemical synthesis to support ongoing investigations to develop and optimize next generation cancer drug candidates. There is also a possibility to work on a drug delivery project. The Intern will work closely with the team and will be exposed to cutting-edge chemical biology techniques ranging from structure-based drug design to biological evaluation of synthesized compounds. The main focus is the generation and purification of novel compounds using classical solution phase synthesis combined with automated or manual solid phase synthesis. During this program, the candidate will work with state of the art instrumentation, and will collaborate with diverse departments. The position offers a unique opportunity to combine both, applied as well as basic research and is ideally suited for candidates that have a strong interest in both of these aspects.

Position 2
The Intern will be working on a project focused on the purification and biochemical assay development of a kinase and coactivator that are critical components of an oncology signaling pathway. Upon the successful completion of the above aims, the Intern will participate in the selection and discovery of novel chemical matter aimed at inhibiting the protein:protein interaction of these two proteins.

Position 3
  1. Performing cellular uptake experiments on mammalian cells to study the internalization of peptides
  2. Phage panning approaches to develop cell-penetrant peptides

Important Information

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity protections, view the EEO is the poster.

If you have a disability and need an accommodation in connection with the on-line application process, please email us at US.Accommodation@roche.com.

Genentech will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.