Utilities Frontline group is looking for candidates in 2013 that wants real-world learning opportunity in the Pharmaceutical/Biotechnology Industry. The candidate’s responsibilities include assisting Utility Frontline (UFL) Automation Engineer in
 
1) Lean Six Sigma and other continuous improvement projects
2) Implementation plan and test protocol generations
3) Change implementation
4) Programming of PLC and HMI

Candidates should be comfortable with some repetitive administrative task. Candidate should also be able to follow appropriate SOPs and other written procedures and document all work with great attention to detail.  In return, candidate will acquire hands-on skills and knowledge of Automation, and Industrial Control Engineering used in the Pharmaceutical/Biotechnology Industry.

Job Responsibilities:

• Provide assistance to the AE with data collection for Lean Six Sigma project
• Provide assistance to the AE with the various duties on a day-to-day basis
• Provide administrative assistance to AE such as test protocol generation and change implementation documents development.
• Develop an understanding of Automation system and utilize the acquired skills to projects assigned.

Sr. Competitive Intelligence Manager

The Sr. Competitive Intelligence Manager (“CIM”) participates actively in supporting Genentech's US commercial planning efforts by providing objective, in-depth information about current and future markets and competitive forces.  The CIM acts as a strategic advisor to the US commercial teams with deep expertise in current and future competitive drivers in the marketplace as well as functional expertise in how to use CI to develop competitive strategies.

• Provide an objective commercial viewpoint based on an in-depth understanding and analysis of commercial, clinical, and scientific competitive information.  Make recommendations on brand strategy that prepare the brand for a competitive marketplace.
• Liaise with global CI counterparts to ensure up-to-date competitive intelligence and assumptions are shared with all appropriate US teams (includes congresses, news flashes, pipeline updates, therapeutic area landscape reviews)
• Collaborate with brand to plan for competitor launches by co-planning local strategy wargames and supporting rigorous competitive readiness plans.
•  Lead competitive threat assessments to develop rigorous team assumptions about key competitors; ensure local assumptions are consistent with global assumptions.
• Provide situational analysis support for quarterly business reviews, brand planning, launch readiness reviews, etc.
• Field intelligence facilitation, including managed care teams
• Work on innovative programs to increase the value of competitive intelligence processes and practice, and analyze the success of these programs.  Liase across the broader Market Analysis & Strategy organization to deliver holistic analytic insights to the brands.  Inform, communicate, and collaborate with MA&S partners.
• Manage one to two direct reports, which will include ongoing coaching and development discussions with tangible action plans for leveraging strengths and addressing areas of growth.

• Works with others to assess existing learning & development curricula and specific programs and other offerings and compare/contrast with immediate-, medium- and longer-term business needs, strategic goals, other targets and anticipated results
• Works with others to build appropriate and aligned annual or longer-range learning & development plans that will support business partners and other stakeholders in Commercial Operations in achieving their strategic and operating goals, targets and anticipated results. May individually undertake a detailed needs analysis/data gathering process/project for key learning & development content/topics/subject matter; providing detailed partner/stakeholder input that helps shape the direction, specific offerings, as well as content and facilitation methods/structure for ultimate design and facilitation alignment
• Works with others to conduct internal business partner/stakeholder reviews of learning & development plans, programs or other activities; ensuring up-front internal client input into the shaping and ultimate development of aligned learning/development plans, programs, and activities
• Translates annual or other cycle learning & development plans, programs & activities into a scheduled calendar of specific sessions/dates for facilitation. Supports manager, peers, team members and others however necessary to finalize and disseminate such calendars, as well as respond to any internal client or external partner questions, concerns, or other comments
• As and when requested, supports others in the development and implementation of an aligned learning & development communication strategy/plan/activities to ensure internal partners/stakeholders are fully updated and aware of all assigned learning & development programs and other offerings
• Periodically, as and when needed/requested or appropriate, delivers internal presentations to fully communicate department's offerings and support strategies
• Actively pursues continued education and awareness of field, product, disease state(s)/indication(s) and surrounding marketplace changes/developments, and uses where appropriate to incorporate into program and other learning event/activity facilitation, as well as provide such information to manager and team members for continuous departmental review/assessment of existing learning & development offerings
• Works collaboratively with manager, peers and/or other team members to identify, recommend, and where appropriate/approved, implement new, creative, innovative learning & development offerings, techniques or others
• Uses approved learning & development plans, curricula, schedule/calendar, specific programs and activities for assigned responsibilities to proactively learn program/other activity content and prepare for expert facilitation. Channels questions, other needs or challenges - in advance - to the appropriate partners; further ensuring full and exacting preparation for expert delivery of assigned learning/development content
• As approved, conducts regular field visits, working with field staff and management one-on-one or in teams. Provides field consultation, team and/or individual coaching and development; enabling hands-on learning/development support to the assigned employee/management groups
• Continuously assesses and evaluates impact and overall effectiveness of facilitation responsibilities. Does so by consistently reviewing learning program participant evaluations, as well as soliciting additional or other feedback, extracting key themes, patterns and opportunities and channeling such to the appropriate internal partners or stakeholders
• Works with peers/team members to ensure maximum leverage of existing resources, tools, programs, content, etc.
• Complies with all laws, regulations and policies that govern the conduct of Genentech activities

Join a Biotechnology Leader
For more than 30 years, Genentech has been at the forefront of the biotechnology industry, using human genetic information to develop novel medicines for serious and life-threatening diseases. Today, Genentech is among the world’s leading biotech companies, with multiple therapies on the market for cancer and other serious medical conditions.

Our founders believed that hiring talented, enthusiastic people would make Genentech a success. Today, we still believe our employees are our most important asset. For this reason, we aim to provide employees with a stimulating and collaborative environment where they can make important contributions to medicine and thrive as professionals.

THE POSITION:

The Senior / Market Planning Manager participates actively in Genentech’s commercial planning efforts by providing unbiased, objective, in-depth information on current and future markets, product performance, customers and competitors. He or she has first-line accountability for Market Planning contributions to commercial and cross-functional teams, management of team relationships, and provision of information and recommendations to stakeholders.  Additionally, the Senior / Market Planning Manager identifies critical business issues and opportunities for growth, collaborates with Genentech teams, and works to embed an external market point-of view into the strategic direction of the company. He or she also supports product launch or line extension activities and helps the organization make optimal decisions regarding the lifecycle of the product.

MAJOR RESPONSIBILITIES:

• Evaluate the market landscape, monitor changes and predict trends in market dynamics and competition.
• Provide an objective market viewpoint based on an in-depth understanding and analysis of customer and environmental information. Provide recommendations on marketing strategies and tactic effectiveness.
• Create, validate and refine patient-based, long-range forecasts for product. Communicate revenue information throughout the organization.
• Act as an internal consultant to stakeholders across marketing, sales, managed care marketing, clinical, regulatory, finance, manufacturing, and other functions, to support strategic decision making and help maximize Genentech's commercial success.
• Partner with other brand teams across Market Analysis & Strategy and other Commercial Operations functions to provide a holistic analytical viewpoint to the brand teams.
• Effectively employ primary market research and leverage secondary data to accomplish the above.
• Contribute to the success of the department by leading cross-departmental projects.
• Potentially mange and develop one or more direct reports.

CAPABILITIES:

• Strong command of a variety of analytical and market research techniques, sought out as an analytical expert and, more importantly, as a strategic advisor. Grasps key issues quickly, understands the "big picture" and links market insights to larger issues.
• Uses rigorous logic and methods to solve difficult problems with effective solutions.  Can see hidden problems; looks beyond the obvious and doesn't stop at the first answers.  Uses creativity and ingenuity to develop solutions to complex problems, formulates strategies and approaches that may fall outside historical norms.
• Can deal with ambiguity and act without having the total picture, is able to effectively pose questions in order to "tease out" information required for decision-making. Can handle risk and uncertainty.
• Ability to represent the Market Planning function on commercial and cross-functional teams. Can negotiate skillfully in tough situations with partners and customers.
• Demonstrates persuasive written and verbal communication skills. Is effective in a variety of presentation settings. Is comfortable around, and influential with, higher management.
• Strong commitment to quality. Consistently and thoroughly reviews work for accuracy before sharing with a wider audience. Delivers final products that are well vetted and reliable.

Specific opportunities available in the following areas:  Personalize Healthcare & Companion Diagnostics; Commercial Assessments; Health Information and Technology (HIT) & Industry Intelligence; Managed Markets Analytics

Industry Analytics participates actively in Genentech’s commercial planning efforts by providing unbiased, objective quantitative data analyses to address critical business issues related to access, reimbursement, and managed care influence.  Leveraging strong structured problem solving skills and collaborating with partners in Market Analysis & Strategy (MA&S), Managed Care & Customer Operations (MCCO), Government Affairs (GA), and Commercial brand teams, the Industry Analytics (IA) team translates market phenomena into unbiased, astute, and actionable insights, and creates innovative analytical solutions in support of key business objectives and decisions.   

• Provide an objective commercial viewpoint based on in-depth understanding, analysis, and synthesis of qualitative and quantitative primary and secondary information.  Assess the market impact of policy, regulatory, and development trends affecting GNE’s portfolio, including current or emerging trends.
• Navigate a complex internal set of teams and functional groups addressing the future landscape and impact, and have an appreciation for the nuanced role that Industry Analytics plays in this effort.
• Navigate a high degree of uncertainty while effectively communicating a point of view and best estimate for planning purposes.   Comfort with ambiguity and can act without having the total picture; able to effectively pose questions in order to "tease out" information required for decision-making.
• Collaborate with Market Planning, Brand Teams, Government Affairs, Medical Affairs, Regulatory, Legal and Global partners in order to inform and model assumptions, communicate impact, influence risk mitigation strategies, and support company initiatives and messaging on strategy.
  
• Successfully identify appropriate opportunities to employ secondary and primary market research techniques to accomplish the above. Guide and conduct primary market research as needed to inform key assumptions critical to good decision-making.  Have sound knowledge of the strengths and limitations of secondary data.
• Successfully employ structured problem solving and quantitative modeling techniques as required to inform key business questions.

The Analytics Manager/Sr. Manager participates actively in Genentech’s commercial planning efforts by providing unbiased, objective quantitative data analyses to address critical business issues and to support strategic decision making for the company.  The Analytics Manager will utilize advanced analytical techniques to: 1) Increase understanding of effectiveness/ROI of all promotional efforts including sales force; 2) Mine and analyze longitudinal patient-level data to generate hypotheses for brand teams and to inform primary market research; and 3) Measure the impact of business unit and multi-product initiatives on product specific performance.  The Analytics Manager/Sr. Manager has a broad understanding of pharmaceutical data, including sales and claims data, and which source to leverage in order to answer business questions most effectively.  He/she works with MA&S and Brand team colleagues to understand business objectives and to apply analytics for marketing projects.  The Analytics Manager/Sr. Manager conducts critical analyses by integrating multiple data sources to provide an objective viewpoint and recommendations to the Commercial organization.  He/she utilizes SAS and advanced statistical techniques to:

MAJOR RESPONSIBILITIES:

1. Develop and implement standard ROI principles and analyses and present results to marketing teams (20%)
2. Develop and implement analyses for field force promotion, including customer segmentation, targeting, and promotional response measurements (20%)
3. Make recommendations to brands and other stakeholders on the effectiveness of different marketing tactics (10%)
4. Generalize approach to measuring common programs across the business unit (10%)
5. Establish and maintain data and approaches to measuring tactic interactions and cross-product impact (10%)
6. Partner effectively and collaborate with other MA&S colleagues to provide holistic analytical insight (10%)
7. Develop Marketing Mix models to optimize marketing spends. Create process for effective monitoring and decision making of marketing spends (10%)
8. Represent brand-specific MS approaches and customizations to the broader team to ensure consistency in MS across the portfolio; learn from others, and proactively share and seek out advice on approaches to complex MS situations (10%)

Sales & Operations Planning (S&OP) Forecast Manager/Sr. Forecast Manager

The Sales & Operations Planning (S&OP) Forecast Manager/Sr. Forecast Manager manages and further enhances the S&OP process for the Commercial organization. This individual plays a key role in ensuring continuous supply of products to patients by collaborating with the Supply Chain organization to ensure supply and demand alignment, and to balance financial, manufacturing capacity, risk, and other considerations. The individual in this role will establish and maintain key partnerships across US Commercial, and Global and North America Supply Chain organizations.

Primary Responsibilities:

• Manage monthly S&OP forecasting process to ensure base case and upside demand forecasts are comprehensive, accurate and representative of the most appropriate demand plan in achieving Genentech business goals
• Prepare executive level presentations including demand analysis and scenarios to facilitate discussions and drive Executive Sales and Operations Committee (eSOP) decisions

• Develop metrics and collaborate with brand Forecast Managers to improve forecast accuracy
• Consolidate and submit demand forecasts for all SKUs of in-line and pipeline Genentech products to  the Supply Chain organization
• Prepare standard portfolio reports to provide insights to sales performance for Commercial senior executives
• Actively participate in various cross-portfolio initiatives including tools and system enhancements to support forecasting processes and reporting

• Technical Skills: Actively Provide Strategic Support to Relevant Partners [relevant partners – see above description].

• Conducting Analyses & Scope and Structure Key Environmental Driver Business Questions. With some support and guidance from manager, assumes full accountability for asking questions of partner experts to seek deeper understanding of real drivers of decision-making and to identify core business questions. With some support from manager, appropriately scope and structure projects, establishing a framework, key deliverables, and milestones in alignment with key stakeholders. Demonstrate ability to break complex problems down into distinct parts, simplify complexity, and manage uncertainty.
• Deriving Insights.  With some support and guidance from manager provide strategic insights and recommendations to brand by linking learnings across projects. Assess appropriate use of primary and secondary research, leveraging internal expertise and resources as appropriate.
• Presenting Results.  Presents objective insights from analyses to relevant partners up to and including CLC.
• Level of Expertise.  Is knowledgeable in a variety of structured problem solving frameworks, market research methodologies, and excel forecasting techniques, and can apply them across business questions. Develops relationships and collaborates with relevant cross-functional partners to deliver respective subject matter expertise (see above job description) to teams, acting as point person in MAS&S for respective area.

• Collaboration: 

• POD Collaboration: Collaborate with MA&S Partner Groups to deliver a synergistic analysis to provide an integrated perspective.  With some guidance of manager, leverages expertise of POD to provide an aligned analytical viewpoint, adhering to team mission, objectives and norms outlined in POD guide
• Leads Cross-Functional and Complex Project Teams With some manager support, customizes the collaborative pod approach to address complex cross-functional business questions.  Delivers the Industry Analytics value proposition to partners.

• Resource Management and Planning:  Manages contracts and budgets for assigned projects independently.  Align with manager and partners on project expectations and delivers on them with manager support.  With manager guidance, prioritize and plan workload and identify capacity issues proactively.
• Managing Up: Effectively applies judgment to leverage and inform manager in navigating organization and completing work

• Participates in site and/or regional and/or global PDR Program Management departmental meetings
• Participates as a standing member in the Regulatory Affairs Functional Team (RAFT) for assigned product development projects to help ensure effective and efficient cross-functional PDR coordination, appropriate resources, and timely, thorough ¿and compliant execution
• As assigned or otherwise needed, assists relevant Regulatory Program Management Program Directors with their interactions, ¿communications and planning with various other teams, dependent upon assigned projects and the associated development phase, such as early development core teams, global development teams and lifecycle teams. Helps Regulatory Program Management Program Directors coordinate cross-functional PDR contributions to product development projects and other related activities
• As assigned, may act as a standing or ad hoc member of other teams for special or ongoing initiatives and projects

• Stays abreast of internal and external developments, trends and other dynamics relevant to the work of PD and PDR to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for assigned therapeutic areas and projects. Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics. Briefs teams and management, as appropriate
• Obtains and applies in-depth knowledge of Roche and regulatory guidelines, procedures and best practices
• Stays abreast of therapeutic area product development and other related business strategies and plans
• Supports on one or more regional projects at any one point in time 
• Analyzes data, the regulatory environment and business objectives to advise others on applicability of new or existing regulations and guidelines
• Participates in the development and implementation of the cross-functional regulatory strategy for each project or related assignment
• Supports Regulatory Program Management Program Directors in identifying and aligning cross-functional regulatory resources necessary to execute the regulatory strategy for each project or related assignment
• Supports Regulatory Program Management Program Directors and others in preparing and facilitating meetings, teleconferences and other interactions/communications with regulatory authorities. Establishes effective working relationships internally and externally with regulatory authorities
• Documents meetings, teleconferences and other interactions/communications with regulatory authorities
• Supports Regulatory Program Management Program Directors in providing internal teams with direction on regulatory authority ¿interactions
• Participates in and supports management of ongoing RAFT meetings. Including providing ongoing guidance on regulatory ¿deliverables, compliance, timing and other relevant matters. Helps manage RAFT resources, including documenting meeting ¿minutes and conducting follow-up to ensure action items are completed in a timely and thorough manner
• Helps manage project plan...

This position is for Swing shift (Monday – Friday 2:00pm – 10:30pm).

Main Purpose of the Position:   

• Solve a variety of routine and difficult Manufacturing Quality Assurance and product release issues following cGMP regulations and Genentech standards       
• Perform assigned tasks and work to achieve company goals and department objectives. 

Job Duties/Responsibilities:

·               Follow company policies and procedures.

·               Maintain a state of inspection readiness.

·               Provide input to the development of personal performance goals and departmental objectives.

·               Collaborate with Management to establish and meet targets and timelines.

·               Independently manage competing priorities with limited instruction.

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

·               Identify and recommend solutions to potential procedure, process and system gaps.

·               Provide assistance to customers in support of departmental functions.

·               Participate in the design and implementation of department and cross-functional initiatives.

·               Apply basic theory and technical principles to address moderately complex problems.     

·               Troubleshoot and initiate the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.

·               Serve as a technical subject matter expert (SME) in support of department functions.

·               Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.       

·               Be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies.

·               Perform any other tasks as requested by Management to support Quality oversight activities.

Technical Duties/Responsibilities:

·               Evaluate and close complex, non-investigational discrepancies.       

·               Initiate discrepancy investigations as required.       

·               Draft and route discrepancy summaries to Discrepancy Management.         

·               Perform Assessor and Evaluation activities defined in the Discrepancy Management System (DM...

The Vice President and General Manager for our Vacaville site is responsible for ensuring the safe, efficient, cost-effective, compliant and quality manufacturing of Roche/Genentech commercial drug substance. The individual will oversee all site activities. The VP/GM is responsible for leading and overseeing the assigned plant's operations, management and staff, with direct and indirect reports of over 700+ employees, annual expense and capital budget management of $200+ million USD, with total annual product manufacturing responsibilities in the multi-billion potential product sales. The VP/GM is responsible for all plant operations: including staffing of the plant, manufacturing, engineering, validation, facilities, technology, warehousing, Environmental Health & Safety (EHS) and operational excellence. VP/GM is accountable for meeting the site’s production plans, on-time, on-target and within-budget, and in accordance with all safety, quality, compliance, regulatory, productivity and other performance metrics and targets. The Vice President is a member of the Biochemical Manufacturing Leadership Team; and as such, plays a key role in defining, setting and implementing the long range vision, strategy, objectives of the overall network.

The Vice President will collaborate with peer VP General Managers to create a supply network that:

-- Ensures nimble decision making

-- Enhances operational practice sharing and process governance

-- Facilitates bulk network optimization and workforce planning

-- Facilitates bulk capacity utilization and cost of clinical manufacturing

-- Creates a clear charter and performance measures

Responsibilities:

• Stays abreast of internal and external industry and marketplace dynamics and evolutions

• Acts as a standing member of the Biochemical Manufacturing Leadership Team

• Identifies industry or other marketplace trends and dynamics that potentially impact Roche and its production operations

• Makes important contributions to the annual, medium- and longer-range vision, strategy, objectives and plans for the Biologics network. Includes important contributions to PT's biochemical manufacturing network: network optimization, sharing best practices, lessons learned, leveraging innovations and resources, etc.

• Evaluates new products, new or updated production processes, systems, technologies, equipment or other business and operational strategies and plans for potential implications to Roche/Genentech's manufacturing plants and operations

• As part of the Biochemical Manufacturing Leadership Team, makes important contributions to the site 5-year plans and annual revisions/updates

• Plays a leadership role in PT's talent management review and planning processes

• Champions initiatives, best practices, continuous process improvement, compliance, quality and the like

• Acts as a lead business process owner for biochemical manufacturing core and sub-processes

• Job Family & Role-specific Responsibilities:  

• Drives and delivers business results across the assigned plant; focusing on manufacturing processes that improve reliability, increase simplicity, lower cost, and enable sustainable and scalable growth

• Works closely with partners in Quality & Compliance, Regulatory CMC & Information Systems, Global Supply Chain, and Corporate EHS to develop appropriate safety, compliance, quality, cost, productivity and other relevant policies, procedures, goals and metrics

• Accountable for ensuring the assigned plant consistently meets all cGMP (Current Good Manufacturing Practices) and other regulatory requirements

• Accountable to ensure, at all times, that the assigned plant is regulatory inspection-ready

• Defines, sets and oversees effective and efficient execution against the annual, medium- and long-range vision, strategy, objectives and plans for the assigned plant, its operations, projects, management and staff

• Works closely with Corporate Engineering to plan for and execute plant capital projects

• Responsible for ongoing development and improvement of the infrastructure necessary for the assigned plant to effectively and efficiently deliver against its vision, strategy, plans a...

Support the implementation of Internal Customer Relationship Management process. Leverage knowledge from within PTQS to analyze customer interactions and develop a model for managing interactions between Computer Systems Quality and Informatics.

Currently Informatics performs many activities which we rely upon to ensure the Right-To-Operate. Some of these activities directly support documented requirements for compliance while others do so less directly. Activities vary with complexity and so do the means and ways we interact with each other. Increased variability due to complexity results in less than optimal outcomes. A model for more predictable collaboration, interaction, and participation will improve efficiency, alignment, and customer relationships. An analysis of customer groups and interactions will need to be performed and conveyed via diagrams/charts. The diagrams and or charts will be used to understand the relationships in order to build a governance model for interactions. The governance model will need to minimally include a common understanding of agreed upon customer relationship, basic, concise overarching needs or expectations, and the foundation for: timely communication, appropriate involvement, proper engagement, performance measurement via tool, and decision making pathways.

Key stakeholders will need to be identified. The governance model will be built with customer collaboration. As intern you will be responsible for coordination and scheduling of activities pertaining to the delivery of a governance model, customer relationship mapping/diagrams/charts, and a performance Indicator tool. This means one of the first items after orientation will be to understand the project and then start working on a timeline with actions and planned dates. Your responsibilities will also include gathering knowledge from PTQS SME experts in order to understand best methods for mapping customer relationships. Working together with PTQS and customer to complete the mapping/diagrams/charts. You will need to research performance tools available inside the company and externally and are responsible for providing a list of optional tools and a comparison of benefits for each tool based on the expected use. As intern you will draft a governance model framework as defined by the sponsor, which will subsequently be collaboratively detailed by the customers. You will be responsible for communication and follow up actions with stakeholders.

Strong communication, presentation and organizational skills are necessary.

Intern Project Deliverables

Customer Relationship Management (CRM) governance model
Customer relationship mapping/diagrams/charts
Performance Indicator tool
Presentation of the project which illustrates the work performed, deliverables completed, and value provided

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

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

Job Responsibilities

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

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

The Clinical Pharmacology Department at Genentech, Inc. isseeking a Ph.D. level Senior Scientist who is driven to understand the clinicalpharmacokinetics and pharmacodynamics of novel drug candidates in the area ofOncology.  This individual will beresponsible for the clinical PKPD activities of Biologics, Antibody DrugConjugates and/or Small Molecules in clinical development. This person willhave responsibility for the Clinical Pharmacology strategy in order to ensurethat appropriate dose/route/schedule decisions are made using the state of theart modeling and simulation strategies that are aligned with project needs.This will be accomplished by working in close partnership with Clinicians, Biostatisticians,Clinicians and project teams.  Responsibilitieswill include planning and reviewing study designs, analysis plans, data analysis,interpretation of PK/PD as well as planning, implementation and organization ofregulatory filings (worldwide) and presentation of data at cross-functionalteams, department meetings, conferences and regulatory meetings (worldwide).Additionally this individual will also be directly involved in leading projectsub-teams and representing the function at cross-functional project teams.