The Clinical Pharmacology Department at Genentech, Inc. is seeking a Ph.D. level Associate Scientist or Scientist who is driven to understand the clinical pharmacokinetics and pharmacodynamics of novel drug candidates in the area of Biologics.  This individual will be primarily responsible for the clinical pharmacology activities of Biologics in clinical development. This person will have responsibility for the Clinical Pharmacology strategy in order to ensure that appropriate dose/route/schedule decisions are made using the state of the art modeling and simulation strategies that are aligned with project needs. This will be accomplished by working in close partnership with Clinicians, Biostatisticians, Clinicians and project teams.  Responsibilities will include planning and reviewing study designs, analysis plans, data analysis, interpretation of PK/PD as well as planning, implementation and organization of regulatory filings (worldwide) and presentation of data at cross-functional teams, department meetings, conferences and regulatory meetings (worldwide). Additionally this individual will also be directly involved in leading project sub-teams and representing the function at cross-functional project teams.

...

This position is part of the drug product group within Biologics Manufacturing Science and Technology (BMSAT) organization. The successful candidate will work with a team of engineers and manufacturing technical specialist responsible for fill-finish technology transfer to contract/partner manufacturing sites, as well as process transfer between Genentech/Roche manufacturing sites. The successful candidate will also be responsible for providing ongoing technical support for drug product manufacturing processes across the Genentech/Roche network.  Candidate will ensure technical stewardship across the various CMO product transfers as well as ongoing continuous improvement projects. 

• Serve as a technical lead for one or more fill-finish process transfers to contract/partner manufacturing sites, as well as between Genentech/Roche manufacturing sites.
• Provide on-going fill-finish manufacturing support to the CMO or internal manufacturing sites by performing trouble shooting, product impact assessments during deviations and investigations and process improvements. 
• Work collaboratively with the site MSAT groups, Late Stage Pharmaceutical Development groups, Manufacturing Operations, and Engineering to develop in-depth knowledge of the fill-finish processes and to facilitate technology transfers.
• Author and review technical reports, process validation documents, and portions of regulatory submissions to support licensure.
• Identify and communicate manufacturing best practices, and work to ensure manufacturing process consistency across the different fill-finish facilities.
• Lead and participate in cross-site and cross-functional teams responsible for technical oversight of drug product manufacture and process improvements, developing global standards, troubleshooting issues, analysis of cross-site process performance data and implementation of quality standards.
• Lead and/or guide the product technical teams (PTTs), serve as a member of the PTT, collaborate closely with the product supply chain, quality and regulatory lead.  Participate in Joint Management Teams (JMT) for CMO transfers for functional representation and/or team updates.

...

Level: E4/E5
The position is for a recognized expert and leader as it relates to process and cleaning validation and operations with the ability to gain alignment, advise, coach and train.  This includes expertise in the principles and approaches of process and cleaning validation, and is responsible for leading the continued development, implementation and execution of the process and cleaning programs meeting health authority requirements.  The Principal Technical Manager will develop solutions to complex Quality system and governance issues and initiatives with inter-organizational impact following cGMP regulations and Roche standards.
• Recognized expert and leader as it relates to process and cleaning validation and must have the ability to gain alignment, advise, coach and train Validation and Operations personnel with respect to process and cleaning validation requirements.
• Expertise in the principles and approaches of process and cleaning validation, leading the continued development, implementation and execution of the process and cleaning programs meeting health authority requirements. 
• Develop solutions to complex Quality system and governance issues and initiatives with inter-organizational impact following cGMP regulations and Roche standards.
• Identify and implement solutions to complex Quality system governance concerns and improvement opportunities with multi-site and inter-organizational impact. 

Key Accountabilities:
• Provide Process and Cleaning Validation and Operations expertise to develop, implement, and sustain PQS requirements in accordance with worldwide GMP regulations and Roche standards.
• Act as Global Coordinator for the development, deployment and implementation of the  PQS Product and Process Lifecycle and associated global standards and processes.
• Adhere to Roche’s Quality philosophy and utilize PQS business process and applicable Quality systems, i.e., CAPA and Technical Change Management tools.
• Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.
• Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
Who You Are:
• Collaborative Leadership – Looks for opportunities to help others.  Works well in a collaborative team environment and communicate effectively with customers, peers, and senior management.  Demonstrates respect and appreciation for a diversity of perspectives.  Maintains professionalism in presence of conflict.
• Technical Leadership – Demonstrates ability to provide technical leadership and teamwork in a GxP environment across functional and organizational boundaries.
• Ownership and Accountability – Takes accountability for actions, drives results, and learns from mistakes.  Holds oneself accountable to fulfill assigned tasks and achieve results within timelines.  Initiates additional assignments and assumes responsibilities as appropriate.  Determines methods and procedures on new assignments.
• Communication – Is thorough in capturing all relevant information in communications. Conveys concepts and positions clearly, with straightforward language, both verbally and in writing.  Readily grasps the main points in communication from others.  Asks questions for clarification.
• Planning/Organization – Responds to new requests with appropriate urgency and with an organized approach.
• Problem Solving – Identifies problems, defines problem statement clearly and accurately, and applies structured and disciplined methodology to identify root causes.  Is effective in solution development, risk mitigation, stakeholder buy-in, and execution.
• Customer Focused – Partners with customers and looks ahead to predict future customer needs.  Manages expectations.
• Technology Platform Experience – Has exposure to and expertise in multiple GxP environments.  Executes work in collaboration with multiple technical disciplines.

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Summary of Position:

The non-interventionalprogram (NIP) Coordinator is the specific point of contact for requestsregarding NIPs.  The NIP Coordinatorensures that all NIPs conducted by Genentech are approved, tracked, andconducted in accordance with relevant regulations and company internalprocesses and procedures.

 

Job Duties/Responsibilities:

• Liaison with the BusinessUnits to ensure a proactive review and assessment of all proposed NIPs.
• Provide support to scopestaff handling NIPs by answering questions or providing advice on good NIPpractices as defined in laws & regulations, codes and internal guidelines& SOPs
• Ensure timely involvementof line management in case of violation of good NIP practices
• Create and maintaintraining for good NIP practices, regulations, codes and internal guidelines& SOPs
• Ensure scope staffawareness of ongoing changes to regulatory or local requirements, and new proceduresand policies on NIPs. Co-ordinate in-house and external provider training byliaising with other departments, external trainers, or running courses,including functional orientation/induction program for new employees
• Identify the need forcreating additional or updating existing SOPs or processes/working guidelineson good NIP practices
• Responsible for tracking of NIPs under their scope of responsibilityinto NIP database(s)
• Ensure each NIP has a program outline which details the nature of the program and safety data collection and reporting processes
• Proactively reportsconcerns/issues to the NIP Coordinator Lead toensure compliance with safety SAE and non-serious AE reporting requirements are met
• Ensure a quality control and reconciliation process is in place for on-goingNIPs and conduct a NIP risk assessment at least once a year as per globalSOP(s)
• Liaise with other NIPcoordinators and be a proactive member of the global NIP network (identify newNIP requirements, develop preventive and corrective measures against NIP risks,maintain and promote good NIP practices across GPS and affiliates)

...

Purpose:

This Principle Technical Manager will manage the Quality oversight related to sterile diluents manufactured at a Contract Manufacturing Organization (CMO) located in North Carolina.  This person will be a key member of the CMO governance team to support right to operate and supply of diluents packaged with several critical Genentech/Roche products.

 

Responsibilities:

·         Influence and drive Right to Operate and continuous improvement to achieve compliant and reliable supply of diluent for Roche products.

·         Establish and monitor CMO Quality goals and metrics to drive continuous improvements

·         Recommend, implement, and drive strategic objectives and goals of the CMO relationship

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

·         Manage the release of product, including batch record review, investigations, change controls

·         Partner with the CMO to ensure proper aseptic control during Roche operations

·         Observe end-to end production activities that include filling, terminal sterilization, visual inspection, and labeling

·         Work with CMO to align requirements for visual inspection of diluent

·         Make decisions if issues arise during production

·         Support validation activities, product complaint investigations, creation of Annual Product Reviews, and other quality functions as required

·         Develop/maintain quality risk management plans and risk logs; utilize risk management tools to identify and mitigate CMO quality and compliance risks 

·         Ensure that CMO meets Roche Pharmaceutical Quality Standards (PQS)

·         Participate in regulatory inspections and GNE compliance audits

·         Develop and negotiate Quality Agreement with CMO

·         Support any regulatory filings for diluent manufactured at CMO

·         Present quality topics to varying governance bodies, such as Quality Review Boards, Operational Review Meetings, and Roche/CMO Steering Committees

·         Serve as the Quality representative on cross-functional and multi-site teams

 

 

...

Senior Manager, Internal Communications, Corporate Relations

The Position

The Senior Manager, Internal Communications, reports to the Director of Internal Communications within the Corporate Relations function. This position is responsible for providing internal organizational communications consultation and support to (1) Genentech’s Chief Financial Officer and (2) the Senior Vice President, Secretary and Chief Compliance Officer, Genentech and head of Legal Affairs, North America. In addition, this position is responsible for consulting on communications initiatives from these and other G&A functions to our approximately 12,000 employees, and will play a key role in developing business communications for leaders and for key best companies submissions. This individual will interact with the company’s senior executives as well as with peers in Internal Communications, Corporate Relations and internal communicators throughout Genentech and Roche.

Responsibilities

• Prepare and maintain strategic, annual organizational communications plan for the Finance and Legal groups
• Provide communications channel analysis and usage proposal
• Draft, coordinate written communications & presentations for leaders
• Partner on content and theme development for each department's employee forums (e.g. leadership conferences and town halls)
• Advise on layout and develop content for department intranet sites.
• Partner with Finance and Legal leadership teams and HR on major announcements affecting organization/organizational change
• Consult on and/or prepare and execute communications plans for G&A initiatives that influence how our approximately 12,000 employee experience working at Genentech (e.g., IT, Procurement, Site Services, EHS, Security, etc.)
• Prepare written communications for senior leadership (C-suite).
• Write original content for several best companies submissions.

...

Note: This position is posted as E3/E4 depending on skills and experience.

 

 

The job takes place in an office environment and requires computer use >4 h/day, prolonged sitting, and repetitive motion (keyboarding, mousing, etc.). Occasionally job requires lab investigation and potential exposure to a number of chemicals, including but not limited to: acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compounds.

 

 

Main Purpose of the Position:

·         Provide commercial and clinical product support to ensure highest level of compliance, uninterrupted supply to patient, and continuous improvement in business processes and methods.

·         Represent Quality Control in Product Quality Teams

·         Draft Annual Product Quality Report and Annual Trend Report

·         Ensure Quality Control is ready to execute commercial & clinical manufacturing campaigns

·         Ensure effective corrective and preventive actions are systematically identified, analyzed, implemented and documented to prevent recurring problems and improve product and process quality.

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

 

Job Duties/Responsibilities:

 

• Apply extensive theoretical and cross-functional expertise in the context of company objectives to independently address complex problems
• Subject matter expert in test methodology, systems, or operational process
• Review data and assess against established acceptance criteria
• Perform technical review of data derived from complex tests, including those outside their primary area of expertise
• Evaluate data to identify trends and/or establish limits
• Identify and resolve discrepancies. Design and execute quality investigations and CAPA (corrective actions preventive actions) initiatives as needed
• Review and approve technical / investigation reports.
• Identify, troubleshoot, and solve technical problems.
• Independently identify and lead process improvements and develop resolution of complex gaps.
• Provide input to and oversight for assay transfer and assay validation
• Act as a subject matter expert for equipment qualification and maintenance requirements, as assigned.
• Assure and apply cGMP throughout operations
• Design, develop, and/or approve training material. Receive and provide training as necessary.
• Lead collaborations to support complex and/or multi-site projects
• Serve as subject matter expert in internal and external audits and regulatory inspections
• Write protocols, procedures and reports
• Meets scheduled performance of 95% on time.
• Perform other duties as requested by managers to support Quality activities.
• Interacts with senior internal and external personnel on significant matters.
• Represents organization as a prime contact on initiatives and projects.
• May provide guidance and coordinate work activities of other personnel.
• Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors, including inter-organizational impact.

 

Capabilities Identified for Success:

 

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

...

Finance Manager, FP&A

Reporting to the Associate Director, FP&A, the Finance Manager will support the corporate planning processes, including forecast, budget, and long-term planning.  This position will be responsible for both delivering forecasts/budgets to local management as well as submission of the plans to Basel.  This role will require significant interface with other finance and planning groups across the organization.

Job Description:

• Manage and coordinate planning exercises to meet corporate reporting schedules and goals
• Review and analyze planning data and develop presentations for senior management review
• Act as the primary liaison with Basel (Global HQ) and functional finance teams (at South San Francisco) for all planning-related issues
• Lead ad hoc analyses as assigned to support senior management strategy discussions and decisions
• Proactively identify, design, and implement enhancements to existing planning processes and systems 

...

The incumbent in this position willbe responsible for managing Device Development Quality areas includingdevelopment of Design Controls and associated documentation, documentationcontrol system implementation, as well as coordinating educational forums for projectteams. Quality System areas of accountability include Risk Management, DesignHistory Files, and other aspects of Design Controls. With respect to DesignControls, responsibilities include participation in cross-functional initiativesto develop, influence and globally align the Design Control strategy whileensuring consistent practices are adopted and followed. The incumbent will alsoserve as the primary liaison / spokesperson between Quality and the DeviceDevelopment Leadership team. He/she will work with Device Teams to create,oversee maintenance and continuously improve Design Control processes forteams, and drive consistency in approach and documentation content across thepipeline portfolio to streamline development. Regular interaction with DeviceTeam Leaders is required. The position requires working with teams to developand implement Risk Management plans and Design History Files ensure theapproach is consistently applied across projects. The incumbent will supportinternal and external audits of the department, and is accountable for ensuringthat the department is in compliance with regulatory requirements forcombination products. The incumbent will regularly interface with thosefunctions contributing to execution of the Device Strategy including but notlimited to Clinical, Development, Manufacturing Collaborations, Quality andRegulatory Affairs.  The incumbent willalso support the continuous improvement of business processes related tocombination product development and commercialization, providing linkagesbetween the Design Controls and device business processes. The incumbent willalso serve as a departmental representative for commenting on global regulatoryauthority draft guidance and proposed rules.

 

...

Location: San Francisco, CA or Basel, Switzerland

Primary Purpose of Job (Job Summary)

> Lead and execute on Organizational Communication and Change Management activities in support of projects for the GPP projects.

Principal Roles & Responsibilities/ Accountabilities – Major functions of the position

Management Roles & Responsibilities

* Responsible for the assigned tasks on GPP projects globally

Functional Roles & Responsibilities  

* Lead organizational communication and change management related activities across key GPP projects.

* Assess the needs of change management for specific projects and provide recommendations to address the changes and ensure realization of the project scope and objectives

* Align with and utilize Business Process Excellence (BPE) resources and methodology throughout the project life cycle(s). Ensure that objectives and critical success factors are identified, met and measured.  Strive to develop a well-rounded BPE skill set. 

* Identify risks, anticipated points of resistance and potential lack of sponsorship and develop plans to effectively mitigate these 

* Develop actionable change management plans, including risk assessments, stakeholder engagement, communication, and training plans for any assigned projects

* Coordinate with team members, sponsors, Business process managers, local end users/customers, and stakeholders to ensure alignment with project  and GPP vision, goals, and objectives and understand the needs of customers and stakeholders 

* Work with Team members to integrate change management and communication activities into the overall project plan to secure effective and lasting adoption.

* Facilitate meetings, workshops and other events where communication and change management are required. 

* Actively participate and facilitate at all team meetings as a full member of the assigned project team, 

* In partnership with the Business Process Owner (BPO)/Sub Process Owner ensure an effective business review process with all relevant input about prioritization, impacts, cost/benefits, vision and objectives associated with project deliverables and change management/communication.

* Coordinate with Technical teams and business end users across the project lifecycle in all areas associated with communication and change management

* Work individually and in groups with project team members and stakeholders as needed

* Engage and coordinate with training managers and planners. Make sure the Training Materials and information sharing tools consistently reflect updates with regards to change management and communication (e.g. Roche Wiki, Procurement Manual) 

* Build strong collaborative networks with key stakeholders and ensure communication is concise, consistent and compelling

* Ensure alignment of change management approach and stakeholder outreach across related Infrastructure projects, optimizing stakeholder involvement.

* Ensure compliance with global business process guidelines, policies, and governance.  

* Drive for continuous improvement and scalable and sustainable solutions to meet global needs

* Engage as a fully vested member of the GPP team and support all goals and objectives of GPP

Membership in Decision Bodies and Major Internal Working Groups or Alliances

Decision body, working group

Chair

Member

Guest/ affiliated

Global Pharma Procurement Leadership Team

Procurement Services Leadership Team

Procurement Services BPE Leadership Team 

Procurement Services Infrastructure Leadership Team

GPP Communication, Procurement Academy, Change Management Teams

Project Teams/Related Initiative Teams

Working Relationships

Key internal interfaces:

* Site/Function Procurement Heads

* PMs/ Local Systems Managers / Site Champions/BPm

* Business Process Excellence Leaders/Teams

* Finance and Audit

* Informatics Teams (PGSD / PGST / FPSE)

* Business Process Owner / Sub Process Owner 

* End Users/Impacted parties and stakeholders

* Training Resources/Coordinators and Procurement Academy Leaders

* Project sponsors and steering committee members

* 

Key external contacts:

* External resources for training and coaching as required

...

Purpose:
The Senior Financial Analyst position resides within the Commercial Finance Operations group and plays a key role in the direct support of the Commercial brand teams’ product marketing activities. The Senior Financial Analyst (SFA) supports the brand teams by: (i) driving month-end close activities through reviewing expense accruals/prepays (ii) financial review of new SOWs/ contracts and purchase requisition/PO set-up (iii) supporting the Commercial planning processes i.e. forecasts updates and tactical plans (v) financial performance reporting and variance analysis (vi) actively leads/participates in process improvement projects within the Commercial Finance Operations team. 

Responsibilities:
Directly support multiple/complex brand teams’ marketing activities, meet with stakeholders on a regular basis to gain budget allocation and financial spend input, and to provide regular updates on the status of spend as compared to product marketing budgets and forecasts.
¿ Prepare monthly financial reports and variance analysis comparing actuals to latest forecast (or latest Basel forecast) and budget, and provide insight into remaining forecasted spend and other ad hoc analysis to understand trends of their direct product marketing activities.
¿ Take on other brand/functional P&L responsibilities to further develop knowledge of the business.
¿ Ensure contract policies and processes are followed in a timely and compliant manner focusing on the financial review of vendor agreements and statements of work (SOWs).
¿ Support Commercial Finance’s ICFR assessment by reviewing / researching the list of out-of-compliance transactions and ensuring that material product marketing arrangements with vendors are covered by purchase orders or other approved contracts and are accrued as appropriate in the financial statements.
¿ Identify areas of inefficiency and ineffectiveness and lead projects that improve Commercial financial processes; partner with colleagues, customers and Commercial Finance to assess and implement recommendations in a timely and effective manner.
¿ Proactively and accurately communicate on a regular basis with partners in Commercial Finance (Finance Managers and Leads), brand teams, other Commercial organizations, corporate departments (e.g. Legal and Finance) and external vendors.
¿ Identify and articulate improvement initiatives aligned with group and departmental goals and actively lead and/or participate in process improvement projects, as required.
¿ Serve as a subject matter expert on Commercial finance processes, leveraging in-depth knowledge of Commercial and cross-functional systems, including SAP, T2E and TM1.
¿ Take on the “buddy” role to onboard/train new hires and acclimate them to the commercial funding, contract logistics, budget tracking, purchase order set-up, accrual and forecasting processes and related accounting policies and procedures.

...

The Network Services Operations team is responsible for project deployment and 24x7 operations support of our North America enterprise wired and wireless networks which serve over 22,000 users and are comprised of wireless access points, switches, routers, firewalls, load balancers, proxies, VPN concentrators, and optical network devices.  

We are looking for a results-driven analytical thinker with strong technical and process management skills who can provide imaginative, thorough, and practicable technical solutions to a wide range of difficult problems.  This person will work closely with our architecture and engineering teams as well as vendors to maintain 99.99% availability while successfully deploying emerging network technologies to new and existing Genentech buildings and data centers.

Candidate must have good business acumen and possess strong communication and teamwork skills.  We are looking for an individual with strong time management skills who can work autonomously making sound decisions that are consistent with organizational objectives.  You must have a proven track record for delivering excellence thus enabling us to meet the scientific demands of our biotechnology revolution in information technologies.

...

This position  may be filled at a Strategy Manager or Sr. Strategy Manager level. 
 

The Strategy Manager is responsible for maximizing the value of Genentech's portfolio through the development of integrated pricing and contracting strategies for a specific therapeutic area or product(s). The role involves leading cross-functional strategy development teams, building effective relationships across all GNE franchises, scenario analysis/modeling for overall financial and legal viability, as well as ongoing contract performance assessment/analysis. Position involves extensive cross-functional collaboration with brand teams, Market Planning, MCCO Account Managers, Government Affairs, Health Economics and Global Pricing and Payer Planning.

• Conducting detailed analysis and constructing presentations to support recommendations to senior management on specific pricing actions for new and in-line products.
• Provides a leadership perspective on GNE pipeline pricing assessments for inclusion into payer planning activities, revenue forecast development, and decision-making.
• Works with internal/external partners/stakeholders to conduct regular market research
• Evaluating macro-trends in the healthcare environment that could potentially impact pricing and contracting opportunities and/or risks
• Provides business partners/stakeholders with in-depth analyses, modeling and optimal scenarios needed to determine the best contracting strategies to meet GNE objectives
• Works closely with partners in field Account Management to understand payer/channel customer needs, expectations, challenges, etc.
• Complies with all laws, regulations and policies that govern the conduct of GNE activities

...

Your responsibilities will encompass all the activities involved in carrying out Process Development experiments with bacterial and CHO culture processes. This will include cleaning, sterilization, batching, and inoculation of bioreactors; preparing media and solutions, performing cell counts, operating harvest equipment, process and equipment troubleshooting, and experiment data recording and collection. Operate computers for process control and data entry. Partner with other shift personnel, and staff to carry out complex experiments for the development, characterization and validation of products and technologies. This job includes the improvement and creation of standard operating procedures, implementation of new technologies and equipment, participation in continuous process improvement efforts, and coordination of processes and experiments.

Skills:
The ideal candidate will display a strong focus on safety, quality, detail and results. Must be organized and capable of multitasking, have effective problem solving abilities, and demonstrated mechanical aptitude. Can proficiently perform aseptic operations with a high degree of consistency and quality. Communicates clearly, concisely and professionally in both verbal and written manners. This position requires the ability to effectively work in a team environment with diverse skills and objectives. Successful candidates must have a high level of demonstrated initiative, be self directed, exhibit flexibility in work approach, demonstrate strong follow through and accountability, and embrace positive change.

...

Position requires an experienced Human Capital Management (HCM) Technical Analyst with demonstrated work experience on multiple project and support environments.  This role will require ability to manage complex solutions in a high-pressure, fast-paced environment in close coordination with the customer.  Excellent customer orientation is critical to the role because position is face to the customer.   

Specific responsibilities include: 

• Heavy focus on end user support; Consulting related to HR system functionalities
• Collaborate with business users, end users, system architects, developers, vendors, and engineers on system solutions.  
• Day to day system administration, application monitoring and proactive issue resolution
• Analyzing and resolving IT Incident in co-ordination with Shared Service Centers (SCC) and IT partners.
• Managing standard pre-approved change requests.  Change requests will require system configuration or coordination with solution delivery team. 
• Refresher trainings (focus on usage of current functionality)
• Creating and maintaining knowledge management in close collaboration with local IT Service Desks and Employee Resource Center (HR).

...

This role will be the strategic business partner to local leaders and leadership teams within the PD client organization, influencing the overall people strategy and ensuring effective execution of HR responsibilities. The person in this role will consult, advise, coach and partner with the business on people and organizational needs – ensuring alignment with agreed Group, functional and regional/site initiatives as well as business strategy. This role also partners with local leaders to drive organizational effectiveness including change management.

RESPONSIBILITIES:

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

...

Job Responsibilities:

Reporting to the manager of the Automation Systems group, the Systems Administrator is responsible for development and support of IT infrastructure and vendor application software associated with mission-critical automation systems, including the Building Automation System (BAS), Utilities Control System (UCS), Programmable Logic Controllers (PLCs), and Vendor Supplied Controllers (VSCs). Specific responsibilities will include:

• Perform GMP maintenance activities on automation systems, including monitoring, physical and logical security, backups, and change control
• Respond to system issues (including 24x7 on-call support); Troubleshoot and remediate issues
• Complete discrepancy, investigation and CAPA records as required
• Install operating system and vendor software patches and upgrades; Design and implement hardware upgrades, system expansions and enhancements
• Support site and network projects that involve system changes
• Perform periodic reviews and revalidations according to quality standards and validation protocols
• Assess and manage risks associated with system operation and use, and design and implement improvements
• Support site audits and inspections, and implement corrections as needed
• Maintain system documentation and life cycle support strategies
• Manage vendor support contracts to ensure delivery of products and services, and process renewals to ensure continuous coverage

...

Provides the operational expertise and leadership to one or more clinical operations teams to ensure the effective and efficient delivery of all operational aspects of one or more studies through all phases of Clinical Study Management (Plan, Initiate, Conduct, Close), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations.

Main Responsibilities and Accountabilities:

• Provides direction and leadership to one or more clinical operations teams
• Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management.
• Builds effective and efficient high performing operations teams and ensures team members are aware of their accountabilities, responsibilities and deliverables.
• Creates team culture and promotes team spirit.
• Develops and maintains effective working relationships with SMT members, with particular focus on affiliate teams, external CRO (for outsourced teams) and co-development partner study teams.
• In collaboration with functional management, coaches, mentors, supports, and provides study specific direction to Study Management team members.
• Oversees the development and maintenance of study specific manuals created by the GSA.
• Contributes to the development and management of the study timelines, resources, budget, risk and quality plans
• Ensures operational tracking tools are identified, including systems to meet the needs of the operations team and ensures reporting to the GSL.
• Develops and manages clinical study budgets (including HQ budget) and contributes to staffing/resourcing plans.  Communicates variances in the budget and action plan for resolution to the GSL.
• Establishes study milestones and ensures accurate tracking and reporting of study metrics. 
• Provides operational input into the development of protocol feasibility questionnaires. 
• Provides clinical operations expertise to ensure operational feasibility and delivery
• Leads the development and finalization of site feasibility questionnaires.
• Leads the creation of the study level patient recruitment plan and retention strategies based on feasibility data and input from the affiliate teams and consultation with the GSL and OPL.
• Provides operational input and insight into all study related documentation (including protocol and informed consent form) and processes.
• Analyzes the feasibility data across countries with input from the affiliates and makes recommendations to the GSL for the strategic country and site distribution and patient numbers.
• Oversees forecasting of clinical/non-clinical supplies
• Designs drug assumption and supply chain process in partnership with Pharma Technical Drug Supplies, affiliates and GSL.
• Oversees the forecasting and management of non-clinical supplies to ensure sites have supplies to run clinical study.
• Delivers the operational elements of the study plan
• Chairs operations team meeting and organizes the investigator meetings, monitor training, CRO kick-off meetings.
• Ensures that reporting of SUSARs is established and maintained for the duration of the study.
• Proactively manages actual study level recruitment versus planned patient recruitment status and communicates variance to the GSL and implements contingencies in consultation with the GSL.
• Primary contact with affiliates to maintain oversight of performance, issues, and their resolution and identify systematic issues and coordinates any corrective action.
• Ensures the completion and finalization of any corrective and preventative action plans resulting from internal site audits.
• Oversees the maintenance of drug supplies and resolution of issues with input from the Pharma Technical Drug Supplies.
• Coordinates responses to study questions or issues from Health Authorities or IRBs/IECs.
• Provides operational input into the development and tracking of SMT goals.
• Provides the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work
• Performs ongoing vendor management (e.g., CROs, Central Labs, IVRS, Reading Centers), including independent negotiation of scope of work, budgets, performance management, and issue resolution.
• Develops and executes appropriate site and CRO/vendor audit and quality plans.
• Identifies areas of best practice and process improvements
• Participates in Pharma Development Operations initiatives and programs as assigned.
• Maintains oversight and ensures consistency of the operational aspects across studies within a project.
• Ensures study adherence to ICH/GCP and SOPs
  

...

The Department of Safety Assessment at Genentech provides scientific leadership and plays an active role in the process of drug development from the discovery period through marketed products.

 

We are seeking a Scientist in the Department of Safety Assessment to support drug development. This role will involve working in a collaborative team environment as part of the comprehensive safety assessment of Genentech therapeutics by providing toxicology representation to small molecule programs.

 

Responsibilities:

The successful candidate for Scientist will provide scientific leadership and play an active role in the process of drug development from late-stage discovery through marketed products. Working in a collaborative team environment, the Scientist/toxicologist leads the safety assessment of Genentech therapeutics by creating a best-evidence synthesis of existing knowledge and comprehensive investigations of toxicologic activity. The successful candidate will design and supervise toxicology studies to support the goals of small molecule project teams, work closely with Study Monitors, Pathologists, Pharmacokineticists and Pharmaceutics to deliver high quality GLP and non-GLP in vivo study reports and, as needed, represent Genentech in meetings with regulatory authorities. Responsibilities include interdisciplinary project team membership, preparation and review of regulatory documentation, study reports and manuscripts, participation in toxicology and pharmacology initiatives, and other active cross-functional collaborations. Additional responsibilities include investigations into mechanisms of toxicity, proactive management of potential safety liabilities and communication of impact to teams and governance committees. Experience with cross-functional teams and capability to build productive cross-functional collaborations both within and external to Genentech are desired.

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