| Jun 5, 2013 |
Senior Materials Analyst
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.
...
|
Experienced |
South San Francisco, California |
 |
| Jun 6, 2013 |
Senior Market Planning Manager (with direct reports)
Market Analysis & Strategy participates in commercial planning efforts by providing objective, in-depth information about Genentech's current and future markets, product performance, customers and competitors. Market Planning teams identify critical business issues and opportunities for growth; collaborating with various Genentech cross-functional teams to embed an external market point-of-view into the strategic direction of Genentech. Senior Market Planning Managers act as the lead market planner on Market Planning projects; providing assigned business partners and other internal partners/stakeholders with unbiased, objective, cumulative and in-depth information regarding current and future markets, product performance, customers and competitors. Senior Market Planning Managers may also have people management responsibilities for one or more direct reports. Opportunities in various therapeutic areas including BioOncology. Example Duties and Responsibilities: - 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
...
|
Team Leader |
South San Francisco, California |
 |
| Apr 9, 2013 |
Senior Manager, Promotional Services
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...
|
Manager |
South San Francisco, California |
 |
| Jun 6, 2013 |
Senior Manager, LSPC Operations Manager, Pipeline and Portfolio Planning (PPP) Cross-Portfolio Governance
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.
...
|
Experienced |
South San Francisco, California |
 |
| May 7, 2013 |
Senior Manager, Internal Communications, Corporate Relations - Functional & Executive Communications
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.
...
|
Experienced |
South San Francisco, California |
 |
| May 9, 2013 |
Senior Manager, Brand Protection
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.
...
|
Experienced |
South San Francisco, California |
 |
| Jun 4, 2013 |
Senior Manager of Employee Giving & Volunteerism
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 ...
|
Experienced |
South San Francisco, California |
 |
| Feb 28, 2013 |
Senior Manager - IT - Manufacturing Site IT Lead (Vacaville)
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
...
|
Manager with Direct Reports |
Vacaville, California |
 |
| Jan 14, 2013 |
Senior Manager - ERP Demand & Production Services
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.
...
|
Manager with Direct Reports |
South San Francisco, California |
 |
| May 20, 2013 |
Senior Management Associate, Pharma Technical Development (PTD)
You will be responsible for a wide range of administrative duties supporting the head of Global Technical Development, as well as the global PTD leadership team and the broader PTD organization. As leader of the PTD administrative team, you will handle a wide variety of coordination activities to ensure a productive team environment and culture across PTD . As part of the senior leadership administrative staff at GNE and of the PTLT, you be responsible for working collaboratively across organizational boundaries to support GNE and PTLT leadership. You will deal with confidential and time sensitive material in a fast paced, dynamic, global setting. Your experience and mature judgment will be essential in planning and executing projects, planning offsites, townhalls, celebrations, and other activities helping to create a great place to work. You will represent the PTD organization. You will provide a key partnership to the Head of PTD and contribute to her effectiveness through your ability to multitask, organize, plan, engage, and prioritize with minimal direct supervision. Administrative support includes:- 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.
...
|
Experienced |
South San Francisco, California |
 |
| Apr 17, 2013 |
Senior Maintenance Mechanic
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 ...
|
Experienced |
South San Francisco, California |
 |
| Jun 6, 2013 |
Senior Health Economist/ Principal Health Economist CV/CNS
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 ...
|
Experienced |
South San Francisco, California |
 |
| May 9, 2013 |
Senior HR Business Partner - Product Development
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.
...
|
Experienced |
South San Francisco, California |
 |
| May 9, 2013 |
Senior Financial Analyst, Commercial Finance Operations
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. ...
|
Experienced |
South San Francisco, California |
 |
| Mar 21, 2013 |
Senior Finance Manager
Senior Finance Manager JOB DESCRIPTION: Position is dedicated to supporting the financial management of the South San Francisco Production Business Unit (BU). The position will report to the Associate Director of Finance for South San Francisco Production and is part of the Technical Operations Finance group, which is charged with the financial stewardship of Genentech's Technical Operations organization. MAJOR RESPONSIBLITIES Responsible for the financial planning, analysis, and reporting activities of the South San Francisco Drug Product Manufacturing operation. Act as point of contact between the operating group and the finance organization. Financial Management & Controls - Perform month-end close activities, including monthly production activity, cost allocations and reconciliation of inventory balances. Identify, investigate, and resolve potential issues within tight time constraints.
- Manage and control expense and capital transactions through the corporate accounting system (SAP BW) including maintaining and reconciling accrual transactions.
- Communicate effectively with internal finance departments, including Vendor Finance, R&D Finance, Capital Finance, Corporate FP&A and others to ensure quick and accurate resolution to financial issues.
- Support and direct Internal Control audits.
- Actively participate in development of new business systems and metrics, working with the Technical Operations Finance and Corporate Accounting organizations as necessary to define and implement.
Planning and Analysis - Work with operations teams to provide input on the development and tracking of appropriate metrics and goals for planning horizon.
- Lead business partners in the execution of planning exercises (forecasts, budgets, long-range plans):
- Coordinate efforts of business partners to prepare operating expense, headcount, and capital forecasts so that all submission requirements and all deadlines are met.
- Analyze budget forecast proposals for strategic consistency and suggest modifications as appropriate.
- Provide support for all presentations and submissions.
- Identify and execute opportunities to improve operational results. Partner with Business Unit management to achieve targeted costs and continuously improve.
- Analyze spending and cost of production monthly and provide direction to BU management using SAP.
- Develop financial decision frameworks for operational issues and lead analysis through final recommendation.
Reporting - Perform efficient and pertinent month-end reporting, including investigation of spending and manufacturing variances.
- Prepare and present monthly financial results to site and financial leadership.
- Use financial reporting to direct BU management toward areas of improvement or to surface operational issues.
- Prepare and present quarterly capital spending updates to site and Technical Operations leadership.
- Support Site Capital Governance Team in Capital Reporting, Planning and Financial Analysis.
MAJOR SKILLS TRAITS: - Demonstrated analytical acumen and problem-solving skills.
- Independent self-starter and proactive leader. Seeks to continually improve business processes.
- Strong communication and presentation skills and demonstrated success building partnerships across organizational boundaries (within a manufacturing environment desired).
- Commitment to customer service with a strong sense of ownership for projects and results.
- Must be able to work in a fast-paced environment that often requires commitment of more than 40 hours week.
...
|
Experienced |
South San Francisco, California |
 |
| May 9, 2013 |
Senior Engineer/Scientist, Robotics/Automation for Formulation Development
Genentech is seeking a qualified Scientist or Senior Engineer to be responsible for laboratory robotics and high throughput technology for the Early and Late Stage Pharmaceutical Development departments. The robotics will provide a critical tool to enable high throughput formulation development for projects at various stages of clinical development, from early development to licensure. The successful candidate will be responsible for designing, developing, and implementing robotics and high throughput technologies and associated automated workflows. Following initial implementation, the candidate will ensure full integration into the departments. Thereafter, the candidate will be responsible for iterative improvements to existing applications, and the introduction of new applications to enhance the capabilities of the departments. The candidate will manage a team of individuals to accomplish this work. Responsibilities will include close and effective collaboration with formulation scientists, interpretation of data produced by robotics, troubleshooting of instruments and methods, drafting of technical documents, and supporting regulatory filings. ...
|
Experienced |
South San Francisco, California |
 |
| May 30, 2013 |
Senior Engineer-Validation
Under the direction of the Technical Validation Associate Director the Senior Engineer will be accountable for leading teams and performing validation activities such as Performance Qualification (PQ) / Cleaning Validation (CV) / Process Validation (PV) and Revalidation (RV). Able to collaborate with both plant and all network organizations seamlessly. Is constantly in search of the most creative and innovative solutions to maintaining the highest levels of productivity. Is able to provide the leadership necessary to maintain a high performance culture Responsibilities: Develop and manage the detailed project plans and timelines for the execution of validation activities. Prepare validation & change control documentation, including protocols, summary reports, etc., for validation activities. Act as project manager for validation teams ensuring new systems are implemented within predetermined timelines and financial forecasts. Present and provide rationale for the validation program during periodic audits and regulatory inspections. Procure and manage contractor support for outsourced validation and risk management assignments. Support the change management system for validated equipment, utilities and facilities. Prepare, review and approve relevant sections of regulatory submissions. Serve as a risk management representative on cross-functional and multi-site teams to support integrating risk management into various Product Quality Systems (PQS) such as, Discrepancy Management, Change Control and CAPA. Lead and facilitate Risk Assessment sessions. Provide input into investigations and change control with potential impact to the site risk profile. Foster an environment that encourages continuous learning. Maintain expertise as necessary to stay abreast of technical and industry advancements. Mentor more junior validation engineers and train individuals on practices and procedures....
|
Experienced |
Hillsboro, Oregon |
 |
| May 1, 2013 |
Senior Engineer, Global Biologics Manufacturing Science and Technology Group
Description: This position is in the Global Biologics Manufacturing Science and Technology group, which supports GMP manufacturing of Roche products at internal Roche/Genentech and External CMO and partner sites. This position will primarily focus on leading cross-functional projects, troubleshooting manufacturing and supplier issues, and aligning technical experts to define best practices for Clean-In-Place (CIP), Steam-In-Place (SIP) and microbial control across the Global Biologics Manufacturing Network. In this position, you will need to provide scientific and technical judgment as part of a team responsible for delivering high quality biopharmaceutical products to patients. Integrity, accountability, and strong dedication to the patients we serve are critical to this role. Responsibilities: - Adhere to all applicable compliance and safety requirements, cGMPs, SOPs, and other manufacturing documents
- Lead efforts to provide on-going technical support for production at internal and external 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 investigational and project teams
- Work collaboratively with site Manufacturing Science and Technology (MSAT) groups to develop and communicate best practices for process and equipment design and operation to ensure consistency and compliance across the biologics manufacturing network
- Support product impact and root cause assessments for process discrepancies and Quality investigations
- Travel within the Roche network and to contract manufacturing sites will be required
...
|
Experienced |
South San Francisco, California |
 |
| Mar 26, 2013 |
Senior Engineer, Device Development
Our group is searching for an experienced and dynamic Device Development/Product Introduction Engineer to be responsible for design for manufacturability, assembly, testing, and the interaction between product design and manufacturing process development of parenteral drug delivery devices. This includes design, testing and transfer to production activities for a wide range of combination products, along with providing technical support to partners working on validation, quality and program management.
We are looking for a candidate that has the ability to affect change, deal with uncertainty and deliver to commitment in high quality manner. The environment is challenging, results oriented, and rewarding with opportunities for impact.
...
|
Experienced |
South San Francisco, California |
 |
| May 21, 2013 |
Senior Engineer Security & IAM, NALA Region
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 Engineer Security & IAM, 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
- Lead multi-threaded, globally distributed and complex projects
- Mentor less experienced team members on industry standard design practices
- 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
...
|
Experienced |
South San Francisco, California |
 |