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.

Senior Health Economist (E5)/ Principal Health Economist (E5A)

RESPONSIBILITIES INCLUDE:

-Design, develop, conduct and manage HEOR studies for assigned products and indications in the cardiometabolism or neuroscience therapeutic areas

-Develop, maintain and apply in-depth knowledge of role, including disease state and clinical topics, market/ customer landscape, and emerging issues.  

-Work independently with minimal guidance, direction and mentoring from manager and others to clarify directions and expand knowledge and skills

-Proactively collaboration with various functions including medical directors, commercial, managed care marketing, development and other gMed functions to ensure alignment of activities with key partners and stakeholders

-Develop HEOR strategy for the medical plan for pre-launch and/or post-marketed products.  

-Design and execute prospective and retrospective outcomes research studies, in collaboration with academic consultants and contract research organizations.  -Develop economic models and AMCP dossier chapter to support launch. Manage budgets, timelines and deliverables as planned.

-Lead and/or participate in HEOR and cross-functional projects. 

ABILITIES:

- Demonstrate strong leadership and communication skills; can contribute to the development of vision and strategy in Medical Affairs teams.

- Demonstrate abilities to manage complex responsibilities, to include integration across multiple projects and priorities

-Strong orientation to teamwork: works collaboratively, effectively and efficiently with others in a matrix project team environment

Conduct repetitive, predictive, condition based, reactive maintenance and troubleshooting of production equipment within the PTD Operations and Engineering group.  Assist with engineering and evaluation of existing and new equipment and processes.

Responsibilities:
• Responsible for the maintenance and repair of all mechanical process equipment within PTD Operations & Engineering at the South San Francisco facility
• Conduct general preventative maintenance according to SOPs/work instructions and perform planned and unplanned repairs as necessary.
• Conduct routine inspections and monitoring of equipment and systems.
• Perform troubleshooting of electrical, pneumatic, and mechanical equipment.
• Complete preventive maintenance and assigned paperwork in a timely manner.
• Assist/Manage specialized maintenance and equipment projects as needed.
• Responsible for inputting data to derive performance metrics for management
• Coordinate contractors and work in conjunction with internal business units who perform repairs, modifications, preventive maintenance and installations of mechanical and electrical equipment.
• Provide technical expertise and training to junior staff.
• Assist as a technical SME with identification, purchase, and organization of spare parts.
• Successfully complete training and demonstrate an ability to perform equipment monitoring and operational checks on production equipment.
• Ensure/maintain all process equipment and areas in a constant state of inspection readiness; specifically, but not limited to, the following:
o Cleanliness
o Personnel and equipment safety.
o Area maintained in an organized fashion.
• Continuously evaluate all operational Standard Operating Procedures and Preventive Maintenance procedures for accuracy and applicability.  Submit appropriate change requests to supervisor to correct any deficiencies discovered. Create new SOPs and equipment/system related procedures.
• Interact with PTD Operations and Engineering staff members as well as other internal/external customers.
• Follow established safety and environmental guidelines and procedures for all work performed. Immediately report safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions. Foster a positive safety culture.
• Respond to emergency call-in when regular scheduled personnel are not available

• Managing electronic calendar, scheduling & global meeting management including coordination of telepresence, videoconference, teleconference meetings and meeting materials
• Creating, editing presentations, spreadsheets and word documents, proofreading and compilation of special reports.
• Handling correspondence and shared electronic filing system
• Making extensive international travel arrangements.
• Preparing expense reports.
• Initiating and managing purchase orders and contract processes including PO, invoices and payment tracking.
• Arranging various recruiting activities such as on-site interviews.
• Coordinating meeting and conference arrangements, planning off-site, town hall meetings, and organizing catering
• Leading the PTD administrative team meetings to ensure alignment, awareness of new business processes, and create a sense of community. 
• Delegating various departmental administrative responsibilities and supporting the growth and development of the PTD administrative team.

The ERP Demand & Production Services team is part of the ERP Demand-to-Supply (D2S) team within the Pharma Informatics Shared Platforms & Applications - ERP organization. This global team provides SAP and non-SAP-based solutions and services to our Global Supply Chain (Clinical & Commercial) business function. These solutions include: SAP’s APO (Advanced Planner & Optimizer), SNC (Supplier Network Collaboration), OER (Object Event Repository), AII (Auto-ID Infrastructure), and other vendor and custom solutions, along with integration to various manufacturing and other supply chain solutions.

The Head of ERP Demand & Production Services will provide global perspective and partnership and leverage knowledge across the Roche Group in order to better enable our Supply Chain business to achieve their goals. They will also drive customer demand management, people management,  project management, solution development, maintenance, enhancement,  and operational support. In collaboration with the business, they will develop strategies and plans that maximize the ROI from the use of our solutions.

The Head of ERP Demand & Production Services is accountable for the management and leadership of a team of IT professionals located in Basel, Switzerland and South San Francisco, California, USA, along with the management of shared services resources in Poland and outsource resources - both onsite and offsite. This position can be based in Basel, Switzerland or South San Francisco, California.

As a member of the ERP D2S Leadership team, the Head of ERP Demand & Production Services will: 

• Develop, manage, communicate, and plan effectively to ensure alignment with, and clear understanding of strategic and operational goals of our customers.
• Collaborate  with IT colleagues to ensure that workforce plans, vendor management, budget management, customer change management, staff performance management and other internal processes are conducted professionally and in the best interests of our customers, teams, and other stakeholders.
• Keep abreast of technical developments that may have application in the Pharma / biotech  industry, and promote the use of those that provide strategic business benefits.
• Govern, prioritize, and deliver a portfolio of projects that are aligned with the our business strategy and technology roadmaps.
• Ensure team actively manages incidents, service requests, and change queues in compliance with Roche processes.

The Manufacturing Site IT Lead is the primary IT point of contact for the Vacaville Biotech Manufacturing facility leadership team: an escalation point for issues, business partner on opportunities, communications channel between the site and Pharma Informatics and an active participant in the Global / Regional IT management of change process.

This position also has leadership and management accountability for two virtual teams: An Application Support team that focuses on the support of Local and Regional Manufacturing and Engineering solutions, and a Tools Team that develops and maintains small custom applications for Manufacturing Sites.

Primary Accountabilities

Engagement:

• Matrixed to a member of the Plant Manager’s leadership team, and expected to contribute cross functional leadership and expertise to the success of the site
• Expected to build and maintain close business relationships with site leaders and stakeholders
• Expected to understand the local Biologics manufacturing site business strategy, objectives and priorities, and communicate appropriately within Informatics
• Advise Site Leadership on Pharma Informatics policies and opportunities
• Represents the customer’s view in the overall Pharma Informatics portfolio discussions and informs them about portfolio decisions
• Represents Site in Manufacturing Site IT Lead forum, contributing to cross site initiatives as assigned

Service and Project Delivery:

• Collaborates closely with the global delivery solution centers
• Develops and manages the Biologics manufacturing site Informatics portfolio in alignment with the global business objectives and governance processes
• Drives efficiency by utilizing globally defined best practice processes for Informatics operations
• Follows defined working processes and standards (Corporate, Biologics and Informatics) in the execution of daily duties and job function
• Aligns local activities and solutions with global ones and vice versa
• Works with Global IMs and Solution Center Managers to create solutions and initiate projects
• Ensures true end-to-end services
• Manages local vendor relationships, service levels and contracts where applicable
• Monitors services and provides regular service reports to the Global Information Managers, delivery and business clients

Alignment:

• Ensures standardization of applications by promoting shared processes, data harmonization and architectural compliance where possible
• Ensures that the shop floor and lab systems are optimally operated at the site
• Ensures the applications fit the needs and capabilities of the customer’s organization and SLAs are defined and supported as well as systems remain validated and documentation is maintained
• Ensures standardization of applications and promotes shared processes, data harmonization and architectural compliance where possible

Management:

• Coordinates the analysis, design and development of Tools projects, upgrades, and the deployment of new services or products
• Manage support of ~40 local, regional and global applications 
• Manage production and internal escalations
• Manage M&E (Maintenance & Enhancement) process for Local / Regional Manufacturing and Engineering systems 
• Manage external consultants and near-shore (e.g. ADMD) resources to supplement team
• Manage, coach and support development of individual team members’ careers
• Appraise team and individual performances
• Manage operational and project budgets of the team
• Participate in the Leadership Team for the PT Biologics IT organization

The Position:

The Senior Manager of Employee Giving & Volunteerism

The Senior Manager for Corporate and Employee Giving will create an integrated strategy for sponsorships and service and establish an overall volunteerism approach that better engages our approximately 12,000 employees and meets emerging business needs.  The Senior Manager will interact closely with senior leaders from across Genentech to support the company as a great place to work.

RESPONSIBILITIES:

Apply deep subject matter expertise to establish customized service & volunteerism practices that address business challenges including recruitment, retention and skills development as well as enhancing corporate reputation and general employee engagement.

Drive a cross-functional effort to identify strengths, assess gaps and offer solutions that are unique to Genentech. Ensure understanding of operational issues; actively identify strategic opportunities; recommend decision frameworks and present to senior management.

Drive Genentech’s adoption of best practice and cutting edge approaches (eg Pro Bono & skills based volunteerism);

Create and lead plan for successful implementation and socialization across all key stakeholders. Define and measure progress; develop appropriate first-of-a-kind metrics for success.

Manage support staff for volunteerism & employee giving, including outside vendors and internal contractor staff. Provide support for GNE’s employee-volunteer site-based philanthropic giving teams in Oceanside, etc.

Partner with the Principle Manager for Corporate Citizenship in strategic decision-making to support the design and potential launch of a Signature Philanthropic Giving program for Genentech.

Continue to evolve strategy and objectives to ensure ongoing value to the business

Brand Protection is a proactive initiative to protect patient safety, supply chain integrity and brand reputation by identifying and acting on individuals or entities that intend to mislead healthcare practitioners, caregivers, patients, trade organizations or the public at large for their own illegal gain.    

The Senior Manager, Brand Protection reports directly to the Director, Interactive Marketing and is responsible for overseeing the Brand Protection Core Team, managing key external partnerships, directing ongoing surveillance, executing the communication strategies, analyzing the impact of these entities and reporting initiative progress to Commercial leadership.

MAJOR RESPONSIBILITIES:

• Direct online and offline monitoring of suspect products, diversion, trademark infringement, and promotional abuse in the US market, maintain expert familiarity with core industry trends, including customer, competitive and enforcement dynamics in order to adapt and support various aspects of Brand Protection.
• Serve as the single point of contact for orchestrating Brand Protection activities across the Commercial organization.
• Leads a multidisciplinary, cross-functional Brand Protection Core Team that includes Quality, Trade, Security, Commercial Law, Patent Counsel and Customer Operations. 
• Leads the development of a communication plan that keeps both the CLC and the Commercial organization at large appropriately informed of Brand Protection initiatives and progress reports.
• Track online pharmacies selling Genentech products illegally and analyze behaviors relative to Rx requirements, trademark/copyright infringements, product format/packaging and pricing.
• Execute monthly communication strategies (warning letters) and track response to key actions.
• Prioritize monthly targets for suspect product purchase, secure senior management approvals, and oversee the purchase process. 
• Build and manage relationships with key Federal Enforcement Agencies  (FDA OCI, ICE, DOJ) and partner organizations (NABP, PSI, CDC).
• Develop and manage budgets/resource requests for all Brand Protection activities. 
• Serves as a member of the Counterfeit Core Team.

CAPABILITIES:

• Strong leadership presence with proven ability to influence stakeholders at various levels of the organization (both US and Global); capacity to work collaboratively with peers in pharmaceutical industry and engage support/ alignment.
• Ability to build, lead, motivate and represent matrix, cross-functional teams without direct reporting authority.  
• Superior verbal/ written communication abilities with demonstrated success at communicating complex situations and action plans in a simple, structured and easily absorbed manner.
• Willing to champion new ideas or positions to meet key goals and doesn’t abdicate responsibilities.  Can negotiate skillfully in tough situations with both internal and external; U.S. and Global groups.  Is comfortable around, and influential with, higher management.
• Experience in forecasting and building predictive models to understand impact of diversion on legitimate trade channels.
• Basic understanding of online promotional practices, search engine marketing and social media environments.  Understands consumer behavior and response dynamics.
• Strong commitment to patient safety and compliance requirements.  Maintain thorough understanding of U.S. compliance requirements and legitimate channel definitions.

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.

The successful candidate will be a key member of the Cross-Portfolio Governance (CPG) team within PPP/Pharma Portfolio Management. The CPG team establishes and manages governance operations and decision-making processes for late stage development to enable well informed and timely corporate decisions on portfolio investment and prioritization.

The manager of LSPC Operations works in close partnership with the late stage portfolio committee (LSPC) Business Manager and is responsible for providing project management support for CPG key initiatives and for leading and managing the monthly LSPC decision-making operations cycle.

Responsibilities

• Lead and manage the monthly LSPC agenda preparation process with key stakeholders in late stage teams in efficient, collaborative and transparent way
• Write minutes for the LSPC monthly meetings
• Anticipate, identify, manage and communicate risks to the execution of the monthly operations cycle
• Support LSPC Business Manager in preparing recommendations and proposals for meetings with LSPC Chairs and other senior leadership
• Maintain LSPC Charter, process documentation and required templates for team presentations for committee decisions
• Manage CPG communications with cross-functional stakeholders
• Guide, educate and support late stage teams, finance, PPM and other key stakeholders though the LSPC operational processes
• Actively contribute to best practices and continuous improvement
• Provide project management support to key projects, and programs led by CPG members and sponsored by senior leadership

Job Skills and Expectations

• Excellent project management skills
• A strong understanding of pharmaceutical/biotech industry, drug development process and trends, and business strategy
• Customer service orientation and attention to detail
• Strong oral and written communication skills
• Experience managing process improvement implementation and change
• Excellent interpersonal skills, including clear, succinct and timely communication and proven ability to foster important relationships with customers and key stakeholders.

Sr. Manager, Promotional Services

Location:  San Francisco, CA

Job Description

1. Compliance, Knowledge & Skills

o Follows all laws, regulations and policies that govern the conduct of all activities. Is accountable for being fully knowledgeable of all relevant policies and for abiding by these

o Does not compromise ethics or integrity, or undertake legal risks while pursuing business goals

o Asks questions when in doubt

o Demonstrates leadership among peers by consistent application and modeling of the appropriate compliance, behavior and conduct

o Where applicable, is required to obtain and maintain full proficiency and knowledge of disease state, product and other aspects or issues as provided for and mandated by the company

2.  Team Leadership & Development

o Sets short and long term goals, vision and strategy for the team

o Plans & implements an aligned team structure with clear roles & responsibilities and ensures the appointment/placement of appropriately skilled/qualified team members to meet the different needs/roles within the team

o Hires, develops and retains talent on the team; ensuring alignment of hiring in relation to team structure requirements to help fulfill/meet departmental plans and objectives both in the immediate sense and over time/building for the future

o Ensures direct reports are developed to expand their skills and abilities, as well as relevant product and surrounding marketplace knowledge

o Proactively manages team performance, giving direct, clear, open & honest feedback, as well as recognizing and rewarding successes. Ensures any indirect reports are also regularly appraised of performance feedback. Complies, and ensures the same for any indirect reports, with all company policies & procedures in terms of formal performance feedback & reviews

o Acts rapidly, appropriately, decisively and consistently in cases of observed or reported potential policy violations. Is guided by company policies and procedures

o Ensures team members have access to needed resources and information that will enable them to perform their roles/responsibilities to the best of their abilities. 

o Provides direction, coaching, feedback and guidance to help ensure the team meets or exceeds assigned goals and objectives

o Leads by example in developing personal technical and leadership skills and ensures team members participate in similar opportunities

3.  Planning & Development

o Ensures team and self stay abreast of internal and external changes and evolutions: Genentech business strategies, goals and objectives, market and industry trends, as well as legal and regulatory developments and requirements

o Works with direct reports, brand teams across all Genentech Commercial business units, and external advertising agencies to proactively review and plan for upcoming promotional communication strategy requirements:

* Assigns team member responsibilities by Genentech business unit and/or Genentech brands

* Contributes to strategies around scope, content, order volume, artwork, quality, compliance and other project management direction, requirements and terms

* Plays a leadership role in managing external vendor selection process and programs

* Develops key content for all RFP documentation, including detailed requirements for promotional services as well as process for competitive bidding and selection

* Takes the lead departmental role in identifying and recommending opportunities to optimize their investment

* Ensures the team is meeting the needs of the commercial organization

o Responsible for ensuring streamlined departmental practices, procedures, systems and tools:

* Defines internal workflows and processes; includes development and implementation of DOPs (Department Operating Procedures) 

* Defines all roles and responsibilities across team

* Identifies, recommends and oversees the development of departmental systems and tracking tools, such as digital asset management system, gPrint, etc.

* Defines departmental performance metrics and standards, such as key performance indicators that enable the department and its internal customers to measure effectiveness and efficiencies

o Analyzes and makes recommendations regarding workload balance and required resources and other infrastructure needs to fulfill all project management responsibilities, goals and objectives across all Genentech business units

o Identifies, leads and/or assigns special, other departmental projects, as and when appropriate

o Leads the discovery process of new innovative solutions to the stakeholders that the team will take on as a priority 

4. Project Management & Operations

* Acts as lead industry expert for promotional communications stra...

• Acts as lead of market planning team and primary contact for Market Planning projects and customers
• Supports strategic decision making across assigned areas/responsibilities; helping internal partners/stakeholders to maximize their commercial success
• Proactively evaluates/assesses the relevant market landscape, monitoring changes in market dynamics, competition, clinician and patient practices and needs, as well as other related factors
• Acts as a thought partner and consultant to assigned teams, functions and other relevant partners/stakeholders
• Partners with brand directors and other stakeholders to review and contribute to lifecycle, brand and tactical plans and provide supportive insights to help further inform, shape and influence business strategies and plans
• Provides long-range business plan forecasts for assigned brands
• Where appropriate, may partner with others, to review and integrate product- and market-specific assessments, analyses and the like into portfolio-wide (across all Genentech therapeutic areas and/or beyond) assessments for executive level reviews and decision-making
• Where assigned, helps internal partners/stakeholder to identify and set key performance metrics for assigned brands
• Employs a wide range of market analysis efforts and techniques, including penetration assessments, market share analyses, product concept testing, etc.
• Provides the continuous, in-depth cumulative perspective on the relevant market(s) and brand(s)
• Acts as the expert on the customer landscape, providing in-depth information and insights into customer practices and needs. As such, also possesses and applies in-depth product and therapeutic area knowledge
• Uses his/her understanding of the "broader market" to link insights and recommendations to wider strategic issues, challenges and/or opportunities:
• Synthesizes relevant analyses and prior research findings to develop a cumulative perspective of the relevant market(s) and associated factors; translates such into clear and meaningful implications for communication and review by internal partners and other stakeholders
• Recommends research/analysis methods and matches these to project objectives; understanding potential and/or limitations of various sources and methodologies
• Draws substantive conclusions from results; identifying implications, challenges or other opportunities and delineating clear next steps
• Develops a "command" of data/info sources and a sensitivity to biases
• Performs accurate analyses and thinks creatively about different ways to analyze data and information
• Defines questions and required data; appropriately comprehends quantitative methods and analysis techniques
• Identifies themes across projects and information sources; performing appropriate, aligned and integrated "meta-analyses"
• Where assigned, tracks key performance metrics for assigned brands
• Where assigned, creates, validates and refines forecasts for in-line products, new indications and new market opportunities. Presents updates on revenue information to senior management
• Where applicable, hires, develops and oversees the work of direct reports
• Complies with all laws, regulations and policies that govern the conduct of Genentech activities

Summary

Responsible for producing innovative Biotherapeutic medicine by interfacing with production systems and controls in a cGMP manufacturing environment, maintaining areas of responsibility in a high state of inspection preparedness, managing the performance of both manual and semi - automated warehouse processes to support manufacturing unit operations, collaborating with the network to implement multi-site process improvement initiatives/CAPAs and executing department objectives to support strategic goals.  Partners with the business to deliver business results focused on establishing and improving business processes to improve reliability, increase simplicity, and enable growth, while utilizing a DMAIC data-driven, problem solving methodology to deliver tangible business results.  Responsible for business process analysis, design and optimization to enable the routine delivery of exceptional performance. 
 

Job Responsibilities

Applies a complete understanding of theories and concepts from one's technical/professional discipline to independently address a broad range of difficult problems.May determine methods and procedures on new assignments.

Essential
¿ Manage and resolve technical and compliance issues with Quality, Maintenance, Calibration & EH&S.
¿ Lead teams to execute internal/cross functional and network related projects that may include investigating, analyzing, formulating solutions, identifying improvement opportunities, documenting processes, training, process/system performance improvement and cascading results to management.
¿ Partnering with the customers, communicating/coordinating/bringing together key stakeholders, and delivering real value-add sustainable solutions.
¿ Act as SPOC for compliance or regulatory agency issues within the department
¿ Identify the technical, procedural and equipment issues that may compromise production and compliance, working closely with cross functional / network groups to identify and implement solutions.
¿ Implement and follow through on corrective and preventative actions for variances or regulatory observations.
¿ Represent the department in reviewing and approving all production related documentation requiring approval such as process validation protocols and final reports, planned and unplanned variance reports, documentation change requests, engineering and facility change requests, and validation protocols.
¿ Supports department to meet corporate goals and department objectives.
¿ Representing the department as the change agent.
¿ Deliver project goals on budget and on schedule.
¿ Make recommendations to Management based on business case and analyses.
¿ Lead decision making support and make recommendations regarding best options.
¿ Communicate proactively with stakeholders regarding progress, issues and plans for resolution.
¿ Develop and use project plans to coordinate participants and track and report progress.
¿ 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.
¿ Ability to identify problems, define problem statement clearly and accurately and apply structured and disciplined methodology to identify data-driven root causes.
¿ Innovative and effective in solution development, risk mitigation, and execution.
¿ Work collaboratively with network to implement multi-site process improvement/CAPAs to mitigate compliance related risks.
¿ Ensure that all operations are performed with 100% compliance to documentation cGMP standards.
¿ Ensure maintenance of a safe warehousing work environment that complies with company and state regulations.
¿ Submit reports and compile data for trending and identifying problem areas.
¿ Collaborate with other departments to address issues and meet deadlines.
¿ 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.

The Network Operations Manager will be responsible for providing leadership and technical guidance to a team of Network Engineers throughout North America. He/She will ensure timely response to all alerts, resolving or escalating issues as appropriate while working closely with internal customers to assure continued quality of service. The Network Operations Manager will lead various transformative Network initiatives (Network redesign, infrastructure upgrades, new buildouts), both strategic and tactical in nature, that will address our most important challenges including scalability, stability, and an increasingly complex network. He/she will manage the network in accordance with identified service level agreements (SLA), KPIs, policies, and procedures.  This individual is key in maintaining the highest level of service for our customers, both internal and external.  Additional responsibilities include:

• Delivery services include long range planning, project management, internetworking, network monitoring, capacity planning, asset management, problem management and change management.
• Project responsibilities include managing the North America Network project portfolio approval process; managing project managers and their project activities; monitoring project status; acting as an escalation point for risk mitigation and issue resolution; and tracking project deliverables, schedule and budget to ensure successful project outcomes. 
• Develops annual budgets, and life cycle maintenance projects in order to maintain the corporate network infrastructure.
• Works with our Network Architecture and Engineering organizations to develop initiatives to ensure the strategic fulfilment of business needs, lifecycle management, and continuous improvement, as well as overall customer experience and satisfaction for a specific solution.
• Is responsible for leading (and providing direction for) many vendor initiatives, contracts, and service negotiations. Works closely with vendors, monitoring service delivery, evaluating new technologies, products and services to better position the company from a data networking perspective.
• Constantly reviews and refines support documentation, processes, and procedures. 
• Reports on SLAs and metrics for the performance of the network

Job Duties/Responsibilities

• Leads the development, planning, directing and tracking of the validation of GxP computer systems operated by North American ERP team (i.e. SAP ERP, BW, APO, XI, Solution Manager, GRC, Portal and Business Objects).
• Responsible for the quality systems and processes that ensure computer systems are operated and maintained a validated state. This includes all modifications and / or changes to systems or processes, change control, periodic revalidation activities and ensures a continual state of inspection readiness with regard to cGxP’s.
• Leads the Information Technology and Quality team members to develop and implement validation strategies in accordance with company policies, directives and government regulations.
• Develops and writes validation project plans, master validation protocols, acceptance criteria traceability matrices and summary reports by providing instructions and scientific rationale for the performance of validation studies.
• Leads fellow technical and analysis team members in ensuring quality systems and processed are in compliance with corporate quality directives, policies, standards and procedures.
• Responsible for the maintenance of departmental quality systems and procedures to assure compliance with new and revised corporate standards and policies.
• Coordinates the testing efforts of the IT and business teams with regards to requirements, resource planning, test coverage, test strategies for the orth American SAP systems.
• Coordinates and interacts with all affected personnel in the execution of test scripts and validation protocols and gathering of test data. Ensure all protocol executions are documented and recorded in accordance with company quality policies, quality standards and SOPs.
• Reviews and approves validation data to assure protocol acceptance criteria is achieved and all deviations are completed and recorded according to procedures.
• Ensure all final reports are completed according to procedure.
• Coordinate and manage the application release cycle processes.
• Manage the life cycle documentation.
• Recommends methods for process improvement, detailing process strengths and weakness of existing and proposed procedures and controls
• Participate in internal and external vendor audits and regulatory audit teams.
• Define and maintain GxP training program to support compliance requirements for IT staff.

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.

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.  

o...

The primary mission of the Genentech Research & Early Development (gRED) organization is to discover and rigorously assess promising molecule candidates for viable therapeutic benefits. Within the Early Development segment, the Clinical Operations department is responsible for “first in human” Clinical Trials to assess the benefit and risks of a given therapeutic treatment and is embarking on a 3-year technology program to advance their organizational processes and capabilities.

As the gRED IT Tech Lead, your primary responsibilities are to provide modern technical solutions for the complex business needs in Clinical Operations, to contribute and coordinate IT project work and to support the operational technology landscape within the IT organization. You are a great team player, and self-driven individual who works well with other IT professionals towards the common vision of delivering information systems to enable the company to continue providing novel therapeutics for our patients.

Responsibilities:

• To design, develop, test and implement solutions based on customer requirements with an innovative approach.
• Able to work with customers to gather project requirements and can translate them into a functional solution.
• Provides architectural and engineering input in technical aspects of business planning such as program, project or roadmap planning. Collaborate with Global Architects as required.
• Provides deep technical expertise over a broad set of current technologies and mentoring of other team members in these areas. 
• Within project teams, collects and defines requirements, designs, develops, tests and documents final solutions according to Genentech's project management methodology
• Works with validation teams to ensure GxP validated solutions comply with FDA regulations throughout the solution lifecycle.
• In an operational setting, manages the deployment of software enhancements, troubleshoots production systems, contributes to root cause analyses and adheres to customer SLAs all while providing excellent customer service
• Works with a variety of in-house developed, commercial off-the-shelf (COTS) and SaaS software, across the globe, that provide organizational capabilities to manage Clinical Trials
• Experienced with web programming languages such as HTML, CSS, XML, PHP, Python, Perl and Java on Linux and Windows varieties.
• Experience with Business Intelligence and data warehousing solutions including Oracle databases, Informatica ETL, Business Objects and  Roambi mobile reports.
• Experience with Enterprise solutions including Google Apps, Livelink, Sharepoint, Jive SBS and iOS mobile applications.
• Collaborates with internal and external business partners and can lead contractors and vendors in design, development and testing activities.

The AE&O Senior Project Manager scopes, plans and manages local, regional and global IT projects consisting of one or more delivery streams. He/she works with solution owners and project sponsors within AE&O (Architecture, Engineering & Operations) and SP&A (Shared Platforms & Applications).

As part of a team of project management professionals he/she reports to one of the Team Leads of Project Management within AE&O Project & Portfolio Management and is supported by portfolio analysts of the AE&O PMO and SP&A PMO (if applicable).

The Senior Project Manager is responsible for scoping, planning, managing and controlling global IT projects and reporting in a timely, accurate and transparent manner following standardized methods to allow accurate portfolio management and project execution control within AE&O and SP&A.

The senior project manager works closely with a responsible portfolio analyst from the PMO in AE&O (or SP&A) to ensure timely and accurate project reporting on project scope, schedule, cost and resources, as well as project risks, issues, action items, and dependencies.

In addition the senior project manager needs to collaborate closely with the Finance, Quality & Procurement departments as required. Also the involvement of other Pharma IT areas outside of AE&O and SP&A (as internal project workforce) might be required (e.g. Roche’s Shared Service Center in Warsaw).

Major Responsibilities include:

• Project Scope Management - Formulating and defining scope and objectives of the project in collaboration with the responsible Solution Owner and ensuring communication of project goals, schedule baselines, and business direction to all identified stakeholders
• Project Stakeholder / Communication Management - Identifying all relevant project stakeholders and establishing and implementing an appropriate communication plan to manage their requirements
• Project Delivery Primarily - Delivering the project on time, on approved (baseline) budget, within quality limits, and with the expected benefits, as defined at project entry and project baseline gates and through controlled and documented change management throughout project delivery, as needed
• Project Risk, Assumption, Issue and Dependency (RAID) Management - Actively managing risks, assumptions, issues and dependencies (RAID) by carefully assessing potential impacts in collaboration with the respective project teams and proposing appropriate mitigation actions. Is also responsible for identifying, actively managing and integrating with any dependent projects or activities.
• Project Planning, Tracking, Control & Reporting - Creating baseline project schedules and tracking the completion of project deliverables, tasks, activities and milestones. Providing accurate, timely and fit for purpose project status reports using established norms and reporting tools of the portfolio
• Team Building & Leadership - Organizing and supervising the appropriate involvement of project resources and actively managing and addressing the resolution of conflicts within the project team.
• Compliance – Directly accountable for ensuring compliance with project management, portfolio management and CSV policies, guidelines, process tools and reporting standards of the portfolio. These norms will include all system qualification/validation state documentation, project documentation and resource forecasting/tracking, financial forecasting/tracking and governance procedures of the portfolio for the specific projects assigned