The Clinical Pharmacology Department at Genentech, Inc. is seeking a Ph.D. level Scientist who is driven to understand the clinical pharmacokinetics and pharmacodynamics of novel drug candidates in the areas of Oncology, Immunology and/or CNS . This individual will be responsible for the clinical pharmacology activities of delivering Small Molecules in clinical development. In addition to having responsibility for the Clinical Pharmacology strategy to ensure that appropriate dose, route, and schedule decisions are made using the state of the art modeling and simulation approaches. This will be accomplished by working in close partnership with Clinical Science, Clinical Operations, Regulatory, Biostatisticians and other functions which make up project teams. Other responsibilities will include planning and reviewing study designs, PK/PD data analysis and interpretation of analysis, as well as planning, preparation and implementation of clinical pharmacology sections, and organization of regulatory filings (worldwide). Clinical Pharmacologists at Genentech often present data at cross-functional teams, department meetings, conferences and regulatory global health authority meetings (worldwide). Additionally, this individual will also be directly involved in leading interdisciplinary sub project teams and representing the function at cross-functional project teams.

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Accountable for end-to-end infrastructure and ensure thecomplete integration of the solutions into the operational landscape. SupportSolution owner with lifecycle management and Components.

This includes installation and upgrade throughmaintenance and operations to decommissioning.

1.2 PrimaryResponsibilities

• Provides technical Subject Matter Expertise input into solution design, optimization, change requests and problem resolution
• Participates in implementation of new projects and in changes of existing solutions and actively execute project related tasks and activities.
• Coordinates and manage installations, upgrades, changes and software integration including test design, execution and support
• Ensures the integrity of solutions and qualified state during their lifetime
• Coordinates and supports security patching and upgrades with the Solution Owners
• Ensures compliance with security SOPs/policies, and that adequate access rights are given to trained staff.
• Coordinates incident management activities with Solution Owners and the AE&O component Managers until final resolution and supervise re-active problem management process

• Identifies and analyzes potential areas for improvement of the solution (pro-active problem management), and Delivers continuous improvement of the solutions assigned.

• Represents the Delivery Organization into AE&O so that the business is represented in technology decisions, planning and participation.
• Ensures solution design and integration of the AE&O skill sets required to support the new solution
• Ensures re-use of existing AE&O solutions and components wherever possible to minimize the development of new solutions
• Ensures all new solutions are designed and developed in a cost efficient manner, delivering the appropriate level of service quality

• Ensures communication of AE&O initiatives, policies and important activities to appropriate Delivery Organization.

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Market Planning Manager, Oncology - Global Product Strategy

Participate actively in global commercial planning efforts by providing objective, in-depth analyses on current and future markets, product performance, customers, and competitors. Additionally, identify critical business issues and opportunities for growth, collaborate with Genentech/Roche teams, and work to embed an external market point-of view into the strategic direction of the company.

This Global Market Planning Manager / International Business Analyst position is a global role based in South San Francisco. This individual will be a member of a global cross-functional team focusing on development of our pipeline products and will be required to travel domestically and internationally.

KEY ACCOUNTABILITIES:
*Proactively and continuously assess the relevant marketplace and its dynamics, customers and competitors to enable strategic decision making regarding brands and business operations.
*Business partner within assigned cross-functional teams: developing strategic insights and providing in-depth product and marketplace knowledge.
*Ensures alignment across internal partners, stakeholders, and senior management.
*Leads initiatives to facilitate growth and development of the Global Strategic Analytics team
*Responsible for new market and product opportunity assessments.
*Creates, manages, validates, and refines forecasts (product and market)
*Communicates revenue forecasts and assumptions to internal partners, stakeholders, and senior management.
*Develops and implements market research plans, in conjunction with cross-functional teams.
*Provides analytical input to the Disease Area Director during due diligence for in-license opportunities and liaises with partnering groups.
*Actively contributes to cross-functional or other project teams, helping the overall business evolve, improve & excel.
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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

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Lifecycle management of Enterprise Directory systems (Microsoft, SUN, Kerberos, Radiant Logic VD)

Lifecycle management of Federation systems (Ping Federate, Siteminder, Microsoft ADFS)

Work on projects related with these components

Create and manage Single Sign On integrations (Ping, Siteminder, JBoss)

Support other Identity and Access Management teams: Identity Systems, Access management, on/off boarding (worldwide presence)

Participate in security hardening drills, audits, proof of concept

Work on user requests, incidents and problems

 

• 2-7 years of successful technical experience supporting Enterprise Directories, Single Sign-On solutions and Federation Services for internal and hosted/SaaS applications
• Proven technical operational skills, and capability to create and validate well-structured answers and solutions in area of responsibility
• Proven interpersonal skills to interact effectively with Informatics staff in multiple countries and varying cultures
• Good understanding of Identity and Access Management systems, operations and related processes with focus on Active Directory, Federation Services, Kerberos, SUN LDAP and Password Management solutions.
• Provides 2nd level support related to Enterprise Directories, Single Sign-On and Federation Services.
• Documents the corresponding processes and components/solutions
•  

Problem Management

• Follows ITSM processes for 1st level problem management
• Act 
• s a source for establishing and recommending that multiple incidents should be declared as a problem to the relevant service providers. Tracks problems until resolved.
• Ensures accurate and complete problem tickets logged in ITSM tool adhering to Roche ITSM processes
• Ensures the Knowledge Management System (KMS) is updated with workarounds, known errors and solutions

 

Incident Management

• Follows ITSM processes for handling incidents
• Monitors ticket queues for the relevant workgroup action within agreed targets
• Ensures accurate and complete incident and change tickets are logged in ITSM tool and adhere to Roche ITSM processes
• Manages, meets and maintains service levels where appropriate
• Continuously improves own skills and knowledge base of services provided by Roche

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Under the direction of the MSAT Technical Services Manager, the Engineer I, Validation will be accountable for validation activities such as Performance Qualification (PQ) / Cleaning Validation (CV) / Process Validation (PV) and Revalidation (RV) activities. Candidate will be able to collaborate with both plant and corporate organizations seamlessly, will be constantly in search of the most creative and innovative solutions to maintaining the highest levels of productivity and will able to provide the leadership necessary to maintain a high performance culture. Responsibilities: Develop, execute, and manage the detailed project plans and timelines for the execution of PQ/CV/PV/RV activities. Plan and execute PQ/CV/PV/RV activities. Prepare validation & change control, documentation, including protocols, summary reports, etc., for validation activities. Act as project manager for validation teams ensuring new systems are implemented within predetermined timelines and financial forecasts. Provide input into investigations with potential validation impact. Present and provide rationale for the validation program during periodic audits and regulatory inspections. Procure and manage contractor support for outsourced validation assignments. Coordinate the collection, testing and analysis of samples and reporting of results required per validation protocol. Support the change management system for validated equipment, utilities and facilities. Prepare, review and approve relevant sections of regulatory submissions. Serve as a representative on cross-functional and multi-site teams. Lead and facilitate the development of formulation, filling, and packaging, area SOP’s and manufacturing documents as appropriate. Foster an environment that encourages continuous learning. Maintain expertise as necessary to stay abreast of technical and industry advancements. Manage the development and implementation of novel approaches to solving complex technical problems while maintaining required levels of safety, quality (including regulatory compliance), and production....

We are seeking a collaborative individual to contribute to a team that is responsible for generating recombinant proteins by transient transfection of mammalian cells. The candidate’s primary responsibility will be high throughput transient protein production to support research and development projects. The tasks will include those associated with coordinating and performing cell culture operations (i.e. set up, inoculate, monitor, harvest and clean fermentors) as well as experiment data recording, collection and analysis. He /she will display a strong focus on collaboration, attention to detail, proficiency with multi-tasking and analytical ability. The secondary responsibility of this candidate is to optimize our transient transfection process. This includes identifying and solving technical issues, performing process development experiments, and evaluating and implementing new technology/instrumentation based on scientific literature and industry trends.  The right candidate will have experience with supervisory or management responsibilities.

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• Plan and execute stress, performance and functional Test on applications and systems using automation and manual Testing. 
• Maintain an understanding of leading tools and technologies for development of mission critical web, database and related applications. (HP Suite, Selenium, Segue, etc). 
• Lead the development of SQA Test Plans, Specifications and Project Scheduling. 
• Collaborate with other SQA Leads in the development of  QA/QCProcedures, Test Scripts, and SQA lab standards and tools requirements. 
• Identify opportunities for process improvements that streamline development activities while minimizing risk.
• Mentor other team members in testing processes & testing tools in order to execute Test Plans as required
• Manage onsite and offshore testers

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Clinical Specialist - Lytics
Territory: Long Island, NY

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.

The applicable therapeutic area / disease states are: Central Venous Catheter Management and Acute Ischemic Stroke

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.

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An Associate Scientist position is available within the Late Stage Pharmaceutical Development Department.  The primary responsibility will be leading particle identification and analytical characterization efforts to support pharmaceutical development.   These activities include the development and implementation of novel analytical methods, physical-chemical characterization of particles including compositional analysis, and root cause analyses in support of product investigations. The candidate is expected to participate in cross-functional product development teams and work closely with other technical groups including analytical chemistry, protein purification, quality, and regulatory.  Further, the candidate is expected to develop scientific independence and exhibit creativity by identification and evaluation of new scientific opportunities that further the current state-of-the-art....

The job responsibility within the Biological Technologies group in Analytical Development and Quality Control, is to develop, qualify/validate, and troubleshoot biochemical/immunochemical and cell-based assays for clinical and to-be-marketed products.  The candidate will perform testing as needed in support of process development, stability, and lot release according to established test procedures..  Expectations will also include some routine lab maintenance, participate in writing SOPs, test procedures, and participate in training, performing testing, troubleshooting, and/or validation of immunological and cell-based potency methods.  Additional responsibilities may include presentation of data at internal meetings and participating in the evaluation of new equipment and technologies. ...

The Demand Planner/Scheduler is the key interface between PTD Stakeholders and Operations and Engineering to build alignment of plant demand & strategy with the production capabilities and supply plans. This person collaborates cross functionally to drive predictable demand for drug substance and drug product to ensure clear requirements for supply planning.

Our goal is to provide unsurpassed customer service within our organization and partners.  As a member of the Supply Chain Management team, Support Services Process Technical Development, you will be responsible for the following tasks:
• Develop, manage, communicate, and plan effectively to ensure alignment with, and clear understanding of strategic and operational goals of our customers.
• Ensure alignment between mid-term and long term plans
• Drive, monitor and ensure achievement of plant key performance metrics
• Review plant performance and agree upon planning parameters for the upcoming cycle
• Participate in projects that are aligned with our business strategy and technology roadmaps
• Provide input into strategic functions for sourcing and/ or investment decisions
• Act as a Single Point of Contact for our customers for relevant Demand Planning topics (Targets / Key Performance Indicators / Service Level Agreements)
• Collaborate on product forecasting process management, identification and management of strategies to manage demand variability and forecast accuracy
• Continuously analyze the forecast, review, check for imbalances and monitor alerts
• Help articulate and communicate demand uncertainties and risks and develop options for optimizing Inventory, replenishment and demand plans to supply planning
• Responsible for defining the suitable planning constraints jointly with team and is accountable that the agreed constraints are implemented
• Responsible to monitor plan stability and drive continuous improvement to targets
• Responsible for managing key parameters / key performance indicators / targets, used in all areas of operations
• Responsible to present on status and issues of plant metrics and escalating risks to management according to defined thresholds

...

 

As a product manager, you will be responsible for supporting the preparation, assembly, and review of both product and facility-related Chemistry Manufacturing and Controls (CMC) regulatory submissions.

The successful candidate must have broad regulatory and technical knowledge applied to develop, execute and provide oversight in the execution of complex regulatory initiatives and strategies.

The successful applicant will be required to apply practical scientific understanding of drug substance manufacturing facilities and knowledge of pharmaceutical manufacturing to facilitate the preparation and review of regulatory submissions and ensure compliance with applicable regulations and guidelines. The individual will lead and/or participate in cross-functional project teams and work effectively with multiple disciplines and personalities.  The candidate will support ex-US filings, as appropriate and as requested by corporate partners.  Additional responsibilities may include leading or participating in departmental operational excellence and business process initiatives.

Self-supervisory with senior management guidance on strategy. Exercises considerable latitude in determining objectives and approaches to assignments.

The Regulatory Manager must maintain a high level of professionalism, efficiency, and commitment. The successful candidate will demonstrate effective problem solving, strong understanding of regulatory affairs, excellent interpersonal skills and the ability to prioritize multiple tasks. Must have a proven ability to communicate effectively in both a written and verbal format. Ability to work both independently or collaboratively in a team structure. The incumbent will be interacting with FDA to facilitate timely review and approval of submissions.

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QC Associate I (N5):

This is an 18 Month Term position on the weekend shift.

Main Purpose of the Position:     Perform analytical, biochemical, and/or biological testing; data review; and/or related activities that support QC operations. 

Job Duties/Responsibilities:

• Perform a broad variety of basic and moderately complex tests with documentation according to GMP Review data and assess against established acceptance criteria and peer generated data for basic methods.
• Prepare data tables and graphs
• Identify discrepancies andparticipate in quality investigations as needed.
• Receive and provide basic training
• Participate in assay transfer and assay validation.
• Perform testing for equipment qualification / maintenance
• Prepare and maintain standards, controls, stocks, and cultures per established procedures.
• Support the maintenance and compliance of operational areas.
• Assure and apply GMP throughout operations.
• Coordinate with customers to support operational activities.
• Support internal and external audits.
• Work to meet schedules.
• Identify and support resolution of technical problems.
• Actively participate in group and project teamwork; project and process improvements
• Drafts protocols and reports.
• Meets scheduled performance of 95% on time.
• Perform other duties as requested by managers to support Quality activities.
• Works under general supervision.
• Manager provides work priorities, timelines and resources
• Instructions given on new lines of work or special assignments.
• Progress on work assignments is generally reviewed on a regular basis.

 

Capabilities Identified for Success:

• Accountability
• Attention to Detail
• Communication
• Organization and Prioritization
• Policies, Process, Procedures
• Teamwork

 

SHE requirements

Position may involve use of reagents and other chemical compounds, including but not limited to acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compounds…

 

...

The Informaticsteam is looking for a highly skilled Operations Lead, who will support the systemsthat enable the Sales & Marketing business teams.  In this role you will work closely with thebusiness leads, end user community, development teams, vendors and serviceproviders to provide the overall IT service. As service lead, the individual may also play other roles as requiredlike project manager and business analyst to ensure optimal service delivery.  This candidate will be proactive, outgoing and detail-orientedwith excellent problem solving and written/verbal communication skills.  The Operations Lead will have excellentcustomer relationship management skills with a service minded attitude and abilityto translate informatics terminology into business relevant language

 

Further responsibilities are:

• Supports day-to-day operations and / or implementation of projects within area of technical expertise, contributes to and executes implementation plans
• Manages incident and problem management processes as well as release and configuration management.  This includes continuous improvement for the management of the services.
• Acts as the initial point of escalation for incident, problem and change management for the business leads
• Administers change control procedure and processes. This includes the management of the change control board and oversight of approved changes
• Is well versed in vendor management and can look for new opportunities to optimize our vendor contracts and relationships
• Applies complex procedures and defined standards to meet business, customer and technical requirements and leads others in resolution of complex problems
• Leads specialist resources on technical issues within the domain and provides detailed analysis of the operations and opportunities for improvement
• Develops business/technical critical know-how within area of expertise.  Assists in the development of others know-how by passing on knowledge of tools and techniques
• Accountable for rollout of new services and enhancements to existing services
• Familiar with Statement of Work (SOW) and procurement processes
• Tracks problems/issues to resolution with the appropriate level of follow-up with the user community
• Participate in project teams to help identify solutions and requirements for new functionalities and performing impact analysis
• Builds and maintains good working relationships with the business leads and the user base, monitors services and provides regular service reports to Informatics and business leads

...

All candidates are encouraged to apply, however a preferred candidate has been identified.

The ideal candidate must have demonstrated the ability to handle confidential, complex and sensitive information, and the ability to establish administrative processes and procedures to assist the group with projects and tasks.  Candidate will provide accurate and effective administrative support for Managers within the group and coordinate administrative duties with other Administrative Professionals to provide seamless support for the group.

*Manage multiple schedules with heavy calendaring of complete meetings.  Arrange, coordinate and support meetings, events and activities both on and off-site.

*Identify and anticipate needs of the group and plan work activities accordingly.  Look for areas of activity overlap with co-workers and leverage resources to maximize time, resources and dissemination of information.

*Generate, disseminate and maintain documents and information.  Develop, implement and evaluate department work processes and procedures.  Manage deadlines related to business planning as well as special projects.

*Collaborate with Admin team to support complex projects and deadlines.

*Understand and troubleshoot from a broader perspective and anticipate the impact of office admin problems and solutions on the other areas.

* Understanding and experience with approval processes for vendor contracts, ideally within GNE, is highly desirable. A large fraction of the workload for this position will be administering contracts for HEOR research partners.

General office responsibilities include but not limited to:

 *Schedule and coordinate staff onsite/offsite meetings, assist with special projects, schedule travel for staff, process payment and expense reports, plan, schedule and coordinate WebEx’s and teleconferences, maintain files, order department office supplies, order catering and other supplies for a variety of meetings and events, fully utilize MAC and software applications.  Exercise independent judgment and discretion of sensitive/confidential information.

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Lead the development of pharmaceutical manufacturing processes or technologies on bench & pilot scale and implementation on a manufacturing scale.  Collaborate across multiple functional areas such as formulation development, manufacturing and validation.  Utilize advanced engineering principles, concepts and techniques to solve technical problems in the following areas of focus:  storage / handling of protein bulks, freezing, thawing, mixing, sterile filtration, filling, pre- filled syringes, microencapsulation, lyophilization, vial inspection and vaporized hydrogen peroxide. Support or lead technical projects and on-going manufacturing operations including technical transfers between sites and performing trouble shooting activities. Managerial responsibilities commensurate with experience....

This position may be filled at the Sr. Business Systems Analyst or Principal Business Systems Analyst level.
 
The Sr./Principal Business Systems Analyst position is dedicated to business process analyses, design and optimization to enable the routine delivery of exceptional performance. This position sits within the MCCO Data Governance and Management (DG&M) department, which is charged with assisting the Strategic Pricing & Contract Management (SPCM) organization to achieve its goals and objectives.
 
This individual will be responsible for leading cross-functional process improvement projects, representing the department as the change agent, partnering with customers, leading internal efforts within the team, communicating and coordinating with key stakeholders, resolving conflicts within the team, and delivering real value-add sustainable cross-functional solutions. This individual will mentor project team members and staff in industry best practices, process improvement methodologies, and will be accountable for following/improving upon the methodology in alignment with Genentech values and behaviors.
 
This position will lead cross-functional project teams to:

•  Implement practical and sustainable business processes
•  Maintain department scorecards
•  Update and prioritize multiple project portfolios
•  Deliver project goals on budget and on schedule
•  Analyze business, process and systems performance, and identify improvement opportunities
•  Identify opportunities for team members to develop, evaluate and manage business case and cost/benefit analyses
•  Make recommendations to Senior Management based on business case and analyses
•  Lead decision making support and make recommendations regarding best options
•  Communicate proactively with stakeholders and senior management regarding progress, issues and plans for resolution
•  Develop and use project plans to coordinate participants and track and report progress
•  Leverage industry research and analysis
•  Serve as advocate, mentor & role model for integrating best practices into the organization
•  Ensure improvement methodology and tools are utilized effectively to maximize benefits
•  Operate with a high degree of autonomy and professionalism; successfully prioritize workload in accordance with business goals

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• Partner with Device Team Leader to define and execute Device strategy in alignment with Technical Development (TDT) & Lifecycle Team (LCT)  strategies.  Develop realistic project plan/schedule and track Team’s progress in meeting milestones and deliverables.  Facilitate Device team meetings in partnership with Device Team Leader to drive sharing of information, decision-making, issues resolution , risk mitigation and team member engagement
• Ensure Device Team plan is integrated with Technical Development Team plan and aligns with overall LCT strategy
• Define and oversee the Device Team project milestones and key deliverables:
• Analyze & understand the critical path activities ensuring Team members are aware of interdependencies
• Drive flow of information across Team members and relevant key stakeholders to facilitate awareness of Team’s efforts and efficient decision-making
• Escalate unexpected events impacting project schedule, budget & resources to management
• Provide regular project updates to management on project status including risk mitigation plan.
• Monitor resource and project variable costs needed to execute Device Plan and work closely with TDT PM to ensure budget is integrated with TDT plan in PlanSource
• Support relevant design control activities outlined in standard and assist with drafting, compilation and tracking of Design Control Documentation as required.
• Support efforts business process improvement efforts including but not limited to updating business process content, implementing tools & best practices and driving awareness across Teams. 
• Maintain knowledge of system performance at sites and business units, through familiarity with local SOPs, frequent interactions with local system owners, and established performance metrics.
• Be accountable for behaviors described in Genentech’s Core, Common and Critical Competencies.

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This position involves research, development and commercialization of technology for sustained delivery of therapeutic proteins.  The successful candidate will work as part of a multi-disciplinary team evaluating strategies for improved treatment options for ocular disease.  Responsibilities will include the design and execution of in vitro release experiments, evaluation of drug compatibility with formulation and device components, and research on mechanisms of drug release.  Effective utilization of technical staff to support these functions is required.  Projects may also include molecule engineering to enhance delivery effectiveness. Oral presentations to review bodies, preparation of written technical reports, and submission of external publications and patent applications when appropriate, are expected....