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

• Lead and/or participate in tech transfers of purification processes across Roche/Genentech’s drug substance manufacturing facilities and to external contract manufacturing facilities.  Requires close collaboration with cross-functional team to implement, validate, and license Drug Substance processes at receiving sites.
• Responsible for providing on-going technical support for Drug Substance production at contract and partner sites. Includes monitoring process performance, resolving manufacturing deviations, participating in quality investigations, and providing technical approval of document and automation recipe changes to support continuous process improvement.
• Lead and/or participate in global initiatives and cross-functional teams in the areas of downstream processing.
• Work collaboratively with site Manufacturing Science and Technology (MSAT) groups to develop and communicate best practices for process design and operations to ensure consistency and compliance across the biologics manufacturing network.
• Represent MSAT Network on corporate initiatives led by partner groups such as Quality, Regulatory, Manufacturing Operations, Pharma Technical Development, etc.
• Provide technical leadership for topics including support for proposed manufacturing process changes, process validation, discrepancy and investigation evaluations, change control, and regulatory submissions. Some lab work may be required in order to resolve investigations and/or demonstrate proof-of-concept for proposed process changes.
• Responsible for authoring and reviewing technical reports, manufacturing instructions, process validation documents, and portions of regulatory submissions to support licensing processes at new manufacturing sites.
• Travel within the Roche network and to contract manufacturing sites will be required.

Main Purpose of the Position

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

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

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

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

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

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

Job Duties/Responsibilities 

Contract Manufacturing Lifecycle Management

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

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

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

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

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

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

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

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

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

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

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

1.1. Business

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

* Lead project team meetings and technical operations meetings.

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

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

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

1.2. Operations

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

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

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

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Sr. Finance Manager – Pharma Finance Development (PFD), South San Francisco

Description:

The Pharma Finance Development group has ~ 45 people in multiple locations around the globe.  It is a cross-functional, cross-cultural group that supports the Roche Product Development organization.  This role is based in South San Francisco and reports directly to the Director of SSF Pharma Finance Development. 

The Senior Finance Manager is responsible for providing financial management and decision support to the Product Development organization. 

Major Responsibilities:
•   Provide local financial controlling support to several functions within Product Development (Biometrics, Portfolio Management, Global Medical Affairs, Quality)
•   Provide global controlling support in collaboration with global functional controller for Biometrics
•   Act as internal consultant by providing financial consultation and guidance to business partners as needed;  support business in understanding state of finances and actions required to achieve business objectives
•   Provide support for all budgets & forecasts for respective local and global functions supported throughout the year
•   Prepare and present monthly financial results to functional leadership
•   Participate and drive key strategic projects for PFD in support of Product Development
      o Provide strategic financial analytical support that both measures and drives efficiencies within the Development organization and improves decision making
      o Present analysis to PFDLT and the PDLT sub-functions
•   Collaborate with Global Controllers, Life Cycle Controllers and Global Development Heads on cross-functional projects and to ensure Product Developments meets its business objectives

The Position

• Perform final review, cumulative review and disposition of Genentech manufactured cell banks and clinical drug substance, drug product and final drug product.
• Review and approve procedures, tickets and other clinical QA controlled documentation. 
• Provide clinical trial support such as COA/COC/COT requests.
• Provide support and oversight of manufacturing activities on the floor.
• Manage batch disposition activities to ensure that products are dispositioned in accordance with cGMPs, Regulatory, and Genentech Policies and Procedures and adherence to schedule.  
• Set personal performance goals and collaborate with management to establish organizational objectives.  
• Manage competing priorities to meet department and organizational targets and timelines.
• Serve as the Quality representative on cross-functional and multi-site teams.
• Identify, design, and implement process and system improvements.
• Apply advanced theory, technical principles, and judgment to address a broad range of difficult problems.
• Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance
• 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.
• Interface with appropriate departments to ensure that batch disposition items are complete and timely notification to Management of all known delays and significant Quality issues is provided
• Interact with interdepartmental contacts on discrepancy assessment, resolution, and Quality approval
• Support and present in Internal and Regulatory Inspections.
• Participate in the resolution of Quality issues by fostering effective interdepartmental and cross-functional relationships.
• Participate or lead different internal or cross functional projects relevant to QA lot disposition
• Train new personnel and internal customers on relevant business processes.
• Ability to revise or create work instructions, SOPs and business process instructions.

Job Purpose:

The PDQA GCP TA Strategy Lead is responsible for the development and implementation of a GCP risk based strategy to deliver an audit program and quality oversight model for studies/products within a therapeutic area.  This role provides oversight to the PDQA program contacts to ensure consistent application of risk based strategy for each program within a TA, and provide actionable data to Therapeutic Area Senior PD management based on analysis of data (audit/inspection/risk) and identification of trends.  This role is to influence TAs in the area of risk and quality management so they can proactively identify and address issues.

Primary Responsibilities and Accountabilities:

• Design and implement a global GCP risk-based Strategy for audit and risk assessment activities for each program in a TA
• Develops and performs risk assessment strategy on each program in TA 
• Supports Program Contacts in risk assessment for each study in program and helps define PDQA priority studies list 
• Develop and maintain risk assessment tools
• Monitors risk data and recommends risk mitigation strategies to TA
• Oversee completion of TA and protocol specific Quality plans
• Input program specific information into risk assessments of internal processes and service providers
• Provide back-up support to all Program Contacts for a specific TA
• Assess and adjust the audit strategy for CTC audits (internal and compliance audits)
• Functions as an audit report reviewer for outsourced CTC Compliance audits
• Analyze data/metrics from audits, inspections and risk management activities for compliance trends and risks for all programs within a specific TA 
• Develop and deliver summary reports (audit/inspection/risk metrics and trends) to TA Leadership
• Provide compliance advice to the TA/product teams and PDQA staff
• May lead or participate in GCP audits for TA 
• Support inspection readiness and inspection management activities for products within a TA
• Support regulatory authority GCP inspections for products in Therapeutic Area

• Provides leadership and direction to PDQ/PDQA and our customers/stakeholders on GCP related activities/issues 
• Establish strong partnership/relationship with TA Senior PD Management
• Review and provide feedback on study risk mitigation plans/CAPAs 
• Escalate significant compliance issues to PDQA Management
• Support PDQ Partner Services in the implementation and oversight of QMS for PDG 
• Provide responses to GCP questions received from Compliance Help Desk for TA

• Contribute to the development and execution of PDQA goals and initiatives
• Participate in or lead departmental or cross-functional compliance projects and initiatives as assigned
• Assists and/or contributes to the development and/or revision of PDQA SOPs, guidelines and tools

• Maintains highest level of awareness, expertise in international GCP regulations and internal policies and SOPs

Responsible for the administration and operation of the site’s programmable logic controllers (PLC) and provides instrumentation and control engineering expertise to the Engineering Group. Focus on providing operational support for existing facilities with respect to the instrumentation and control systems for process, utility and building systems. Provides operational support and interfaces with the Siemens Building Management and Emerson Delta V systems as needed. 

Job Responsibilities

Essential
Serve as the site subject matter expert for the various PLC systems
Act as the PLC system super user and ensure system equipment and software are maintained in an operational state
Train personnel to interface with PLC systems on equipment and add or delete users based on training status.
Generate alarm reports, identify trends and review data with Quality.
Perform instrumentation and control engineering design services for existing facility projects, including upgrades and capacity expansions, equipment upgrading and replacement.
Review and approve design drawings, and Process & Instrumentation Diagrams which include all line sizing, instrumentation and control philosophies,
Review design specification testing and perform field inspection services.
Interact with vendors.
Review and approve vendor information packages, including drawings and specifications as directed to ensure validation and control system requirements are met.
Play a lead role in the start-up and troubleshooting of process equipment and critical process utility systems.
Generate controlled documents to support the start-up, operation, validation and maintenance of equipment and systems located in existing facilities. Examples include functional specifications and detail design specification.
Provide input into the validation of process equipment and associated utilities.
All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area.  Fosters a positive safety culture in which no one gets hurt.

Supplementary Responsibilities
Support work of the Engineering Group, which includes research/evaluate instrumentation and control components, review/modify control system concept/logic as a result of troubleshooting.

PTR Regional Hub Sr. Regulatory Associate (E3) /

PTR Regional Hub Regulatory Manager (E4)1

Department: Pharma Technical Regulatory (PTR)

Job Family / Category: PTR Regional Hubs

Purpose

This position will be responsible for execution and management of regional life-cycle submissions for all Roche products as well as new product registrations by focusing on local needs of Affiliate Drug Regulatory Affairs (DRA) teams to ensure right first-time submissions to Health Authorities.

Responsibilities:

* The incumbent will be the primary technical regulatory (CMC) point of contact for the Affiliate DRAs and as such he/she will work closely with them and the regional Supply Chain teams as well as with the PTR product managers and the PTR network.

* In coordination with global PTR Technical Regulatory Leaders (TRL), execute regulatory strategy for lifecycle submissions in Asia Pacific markets associated to management of CMC changes originating at manufacturing sites or affiliates toward maximizing efficiency, quality and rate of submission approvals by Health Authorities.

* Coordinate strategic planning with Regional Supply Chain and Affiliates DRA for change management alignment and early visibility/communication/planning of changes impacting markets in the region.

* Assemble lifecycle submissions for markets under responsibility to guarantee right first time submissions and coordinate/manage with affiliates for timely and effective submission of changes to the Health Authorities.

* Act as subject matter expert in regulatory requirements for post approval submissions and maintain the regulatory intelligence repository for regional markets under responsibility.

* Ensure timely update of the CMC change management electronic systems with the regulatory information submitted/approved externally by a Health Authority or internally by the appropriate functional area.

* Upon request, support Affiliate DRA with interactions with regulatory authorities to facilitate the prompt review and approval of submissions (CMC content Subject Matter Expert).

* Manage timely responses to Health Authority questions resulting from lifecycle submissions in regional markets under responsibility.

* Manage tracking of commitments with a Health Authority as result of license/dossier approval and ensure commitments due dates are met.

* The candidate may be required to travel to other Roche sites on a periodic basis.

The Global Engineering team is responsible for making technology happen for Genentech and Roche global by transforming the “technology roadmaps” into live solutions. The Global Engineering team is present in 4 locations: Basel, Madrid, Shanghai and South San Francisco, covering all time zones with around 100 highly qualified engineers. The Senior Network Engineer, NALA Region position is located at the South San Francisco site. The main responsibilities of the position are:

• Design and develop technology solutions, including evaluation of promising technologies and development of evaluation criteria
• Work with vendors, architecture, operations and solution owners managing the Proof of Concept and testing scenarios
• Perform configuration, integration, functional specifications and development tasks for technology solution and services, including first implementation of the designed solutions
• Develop best practices for technology solution for reuse across the compute environment
• Ensure efforts and solutions align and adhere to the organization’s Technical Architecture Framework (TAF) policies, standards and direction as well as Solution Owner requirements
• Ensure proper training of support teams on the technology solution
• Stay abreast of operational difficulties and issues; work with support team staff to provide escalation support 
• Document and optimize technology solution environment as required
• Ensure Quality standards as per company specifications are followed
• Occasional travel and working outside standard office hours including weekends and holidays

The Department of Safety Assessment at Genentech providesscientific leadership and plays an active role in the process of drugdevelopment from late-stage discovery through marketed products. We are seeking an Associate Scientist/Scientist in the Department of Safety Assessment to supportdrug discovery and development.   This role will involve working in acollaborative team environment as part of the comprehensive safety assessmentof Genentech therapeutics by providing discovery and investigative toxicologysupport to early stage small molecule research programs.  

Responsibilities

Proactive risk assessment ofpotential toxicity issues related to undesired or exaggerated pharmacology,investigation or characterization of potential toxicity issues to enable smallmolecule lead optimization and candidate nomination.

In this role, the toxicologist willprovide representation to discovery project teams, which will include safetytarget assessments, strategic planning and designing, implementing andsupervising  toxicology studies in support of compound lead optimization(e.g. in vitro toxicity screening, counter-assay development) and mechanisticinvestigations (development of hypothesis-driven research plans, in vitro or invivo model development and qualification, and scientific projectmanagement).  This position will include staff supervision as needed andcontributing to the continued refinement of lead optimization andinvestigational strategies and identification of new technologies.  Thediscovery toxicologist will interact closely with research scientists andSafety Assessment development toxicologists and pathologists to ensure thatdiscovery teams consider all of the appropriate strategic needs for candidateidentification with regard to toxicology issues, thus providing bettercandidate selection and characterization of toxicology issues at the time oftransition to early development.

• Perform testing of routine and non-routine samples and document according to GMP.
• Perform environmental monitoring and utilities sampling and document according to GMP.
• Review data and assess against established acceptance criteria.
• Perform technical review of peer-generated data for basic methods.
• Prepare data tables and graphs.
• Identify discrepancies, participate in quality investigations and CAPA (corrective actions preventive actions) initiatives as needed.
• Receive and provide training.
• Participate in assay transfer and assay validation as needed.
• Perform 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 supplier/customers to support operational activities.
• Support internal and external audits.
• Work to meet schedules.
• Identify and support resolution of technical problems. Resolve sample issues as needed.
• Actively participate in group and project teamwork; projects and process improvements.
• Draft protocols and reports under supervision.
• Meets scheduled performance of 95% on time (ATS).
• Perform other duties as requested by managers to support Quality activities.

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

Primary Responsibilities:

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

Knowledge, Skill, and Abilities:

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

IT Quality is a trusted partner for customers to ensure and improve the overall quality of IT systems throughout their lifecycle with a focus on compliance with regulatory, legal and finance requirements.  We are looking for a customer-focused, highly collaborative individual responsible hosting and supporting audits and inspections and ensuring audit corrective actions are tracked and closed in a timely manner.   The position is responsible for effective planning and management of audits and inspections with business quality and audit groups.  Further responsibilities include:

• Leads, hosts,  and supports audit management for IT for various sites for internal and external audits and inspections and provides regular updates to stakeholders and informs management of potential issues
• Prepares IT teams for audits and inspections using his/her knowledge of IT controls and auditing practices and provides training to IT staff in support of key IT controls and audit readiness procedures
• Manages the audit program in compliance with quality requirements for ICFR, FDA regulations, legal and security policies, IT controls.
• Facilitates execution of corrective actions ensuring that weaknesses identified in the IT management system are identified, recorded, prioritized and addressed appropriately.  
•   Conducts vendoraudits and internal system assessments for Informatics
• Serves as custodian for legacy IT controls, IT Narratives, Master Audit Schedule to support audit and compliance processes.
• Develops, monitors and improves processes and tools to improve the compliance of  IT systems and to facilitate joint business decision making from a cross-functional and global perspective
• Develops strong working relationships with and partners effectively with IT delivery teams and with global Business Quality, Corporate Audit, Finance and security organizations
• Maintains industry knowledge and skills in the compliance, audit, and risk management and  applies them to improve internal processes and practices

Main Purpose of the Position:    

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

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

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

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

Technical Duties/Responsibilities:

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

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

·         Provide input in the preparation of regulatory submissions.

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

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

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

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

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

·         Execute Airflow Visualization studies and create summary reports.  

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

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

·         Ensure department representation on relevant project teams.

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

·         Communicate group performance against established metrics to Quality Management.

Responsibilities:  A postdoctoral position is available to study oncogenic pathways in breast cancer.  Strong molecular and cellular biology skills are required. The successful candidate should have familiarity with mutagenesis, RNAi, signal transduction, and protein characterization. Candidates with a strong background in protein structure and function will also be considered. A practical working knowledge of bioinformatics analysis would be desirable.  The successful candidate will be required to work in a highly collaborative and multi-disciplinary environment. See recent publications: Cancer Cell 20:472 (2011); Cancer Cell 15:429 (2009); Cancer Res 68:9280 (2008).

Clinical Data Management (CDM) is a department within the Biometrics function of the Product Development (PD) organization.   CDM provides data management expertise to study management teams in PD and in gRED (Genentech Research & Early Development).

RESPONSIBILITIES:

The Study Data Manager (SDM) is a core member of Study Management Teams and serves as the study data management contact at the study and/or program level, providing expert guidance to program teams.  The Study Data Manager leads the CDM study team and maintains oversight of all study start-up, study conduct and study close-out data management issues, activities and deliverables for one or more studies.   The SDM interacts regularly with Clinical Data Management groups to ensure that project objectives are understood and met and provides technical coaching and mentoring on data management activities to colleagues.  The SDM also performs the following: provides early strategic input into protocol design focused on data management issues; leads the development of eCRFs and database development and testing specifications by interacting with other functional area representatives;  responsible for the oversight of all data review and cleaning activities involving close interaction with project clinical research professionals; responsible for the implementation of standards within Study Data Management across one or more CDM study teams; develops and executes ad hoc database queries utilizing data review and query tools;  manages projects resourced externally via contract research organizations or corporate partners; provides support to ensure that study conventions, processes, knowledge sharing and best practices exist across all studies within a program; participates in departmental discussion groups, formal working groups or special projects.