The job responsibility within the ADQC--Biological Technologies Testing Group is to perform cell-based and immunochemical/biological assays in support of process development, stability, and lot release testing with established procedures in a GMP environment.  Role includes reviewing assay packets and releasing assay data as well as prepare assay reagents, generate computer results, monitor assay quality, use of LIMS, maintain the lab via Lean tools such as 5S and EHS safety practices.  Expectations include lab maintenance and project support/equipment qualification/computer systems/document management as needed.

...

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

...

The Position:
Provide technical support and maintain consistent configuration, implementation, operation and support of an Integration Services Platform – Infrastructure Platforms (monitoring, inventory, automation, etc).

Responsibilities:

• Provides technical support and maintains consistent configuration, implementation, operation and support of a single Integration Services platform including:
• Implements new releases and sets up standards for operational management
• Monitors and resolves problems with Business Application operations.
• Configures and manages development, UAT and production environments.
• Administers and maintains support services.
• Configures implements and optimizes Business Applications.
• Manages incidents, problems, changes and releases
• Tunes capacity and performance
• Coordinates, tests and administers platform Security
• Complies with OLAs and Quality/Validation requirements
• Ensures ITSM framework, processes, tools and SOPs are implemented, utilized and supported end to end

Applies the processes above to the following Integration Services platform areas:

• Monitoring Solutions (NetIQ, others)
• Inventory Management solutions
• Automation and Provisioning solutions (HP Orchestrator)

Key Objectives:

• Business Application Installation and Daily Administration
• Business Application Performance Tuning
• Business Application Availability
• Support to ensure quick incident resolution
• Engineer new release and setup standards for operational management
• Standards and procedures are followed
• Understand and apply ITSM and process best practices
• Understand and comply with applicable ITSM roles and responsibilities
• Provide Support in measuring and continuously improving process performance and adherence to service level / operating level requirements.

...

This South San Francisco, CA-based position has the responsibility for operations support of all Pharma and Diagnostics Contact Center infrastructure in the North America (NA) region.  This includes 39 contact center groups across two (2) main campuses and six (6) additional sites, handling over 5 million calls in addition to a large number of fax, email and other interactions per year.  This individual is a thought leader and strategist and will have a deep understanding of contact center technologies and processes.  He/She will work on unusually complex technical problems and provide solutions, which are highly innovative and ingenious. This individual will serve as technical lead on large-scale enterprise project teams, that will transform how our contact centers are currently doing business. He/She will work with IT Architecture to evaluate and analyze emerging technology associated with delivery of voice calls and other interaction channels and corresponding data as well as influence the development of contact center roadmaps and strategies in order to meet the business needs within the NA Region. It is critical that this person understand the individual needs of each line of business within the NA Diagnostics and Pharma contact center business units.  This position requires a solutions-oriented individual who can be dedicated to serving the business by leveraging technical expertise, strategic planning, clear business understanding and excellent communication and collaboration skills to deliver first-class voice and contact center infrastructure and support.

This position will help consolidate the current disparate NA Contact Center solutions into a single regional, centrally supported platform that will meet the current and future needs of the business.

You will have the following key responsibilities:

• Operate as the SME and process owner for Contact Center Solutions in NA
• Key contributor in strategic planning and development of annual goals, budget and objectives for NA Voice Services
• Key contributor to TAF Roadmap and technology for NA Enterprise Voice and Contact Center systems and related solutions
• Collaborate with architecture and engineering on technical aspects of Telephony and Contact Center infrastructure and solutions
• Work with the Global Head of Voice Services and appropriate team members to define, develop and implement Global, Regional, and local standards and SOPs 
• Provide leadership and visibility for Voice Services NA Region within the Global IT Architecture, Engineering & Operations organization 
• Provide deep technical expertise over a broad set of current technologies and mentoring of other team members in these areas
• Create collaborative partnerships across IT and the business
• Ensure regular on-going communication is happening in all areas of responsibility with critical stakeholders to create awareness and set expectations 
• Act as an advocate and serve as a trusted advisor to the business
• Work with Commercial Marketing on FDA Drug approvals and launches and new programs and special toll free number assignment 
• Work closely with the business to understand portfolio and prioritization of business requirements
• Develop and maintain clear project process and engagement models and communicate through proper channels to ensure alignment with the business for successful implementation and delivery of contact center projects
• In an operational setting, oversee the deployment of software enhancements, troubleshoot production systems, ensure root cause analyses (RCA) is performed for all outages and adheres to established SLAs all while providing excellent customer service
• Provide leadership, vision and mentoring to the Voice Services and Telecom vendor on-site staff
• Monitor legal and regulatory compliance of all voice systems, including adherence to HIPPA and California State standards for voice systems 
• Participate in leadership activities to promote the achievement of all goals and objectives
• Look for new opportunities for infrastructure consolidation and centralized management

...

Individual contributor Patent Attorney/Agent to prepare, file and prosecute patent applications, with a primary focus on the protection of inventions and patent prosecution relating to small molecule therapeutics.  Maintain a substantial and active prosecution docket of U.S. and foreign patent applications, with interference, reexamination, post-exam, and opposition practices as they may arise with prosecution. Develop in-depth expertise in particular areas of small molecule drug discovery in order to provide guidance on patent law issues to business groups and scientists conducting research in those areas. Position will also involve diligence work (including freedom-to-operate, infringement and validity analyses), agreement support work (including MTAs, CDAs, research collaborations, and licensing agreements), management of external relationships with outside counsel and collaborators, and interactions with global affiliates....

Main Purpose of the Position: Provide direct manufacturing Quality Assurance support to Production (Inspection, Packaging, Aseptic Operations) in a GMP environment. Act as a key Quality contact to manufacturing for discrepancy management, batch review, and line support. Assure compliance with cGMP regulations, Roche / Genentech standards, and applicable Regulatory Guidelines. Solve routine Quality Assurance issues limited in scope and complexity 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. Meet assigned targets and timelines with minimal supervision. Prioritize assigned tasks within a fast paced environment. Participate in process improvement and system design teams. Provide assistance to customers in support of departmental functions. Work with colleagues to maintain cross-functional and cross-site process and procedural consistency. Receive specific instruction and work independently to complete tasks. Apply basic theory and technical principles to address routine problems. Troubleshoot and assist in the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships. Sign documents for activities as MQA as 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: Perform Inspection and Packaging AQLs. Perform Line Clearances for Inspection, Packaging, and Aseptic Operations areas. Initiate and close discrepancies and child records as required. Review batch records in the Inspection, Packaging, Aseptic Operations areas. Perform Assessor and Evaluation activities in the Discrepancy Management System. Interact with interdepartmental contacts on discrepancy assessment and resolution. Provide Quality oversight to internal and external customers. Review and approve controlled documents relating to processes, equipment, facilities and utilities in the manufacture of product. Collaborate with departments to ensure that all review activities are executed efficiently and effectively. Support Quality process improvement initiatives. Support the execution of departmental deliverables assigned by project teams. This is a SWING shift position: Monday, Tuesday, Wednesday, Thursday, and Friday – 4:30pm to 1:30am...

Industry Analytics Manager / Sr. Manager – Managed Markets Analytics

Job Description:

Manager/Sr Manager, Managed Markets Analytics: Collaborate with cross-functional partners in Industry Analytics, Market Analysis & Strategy, the Managed Care Contracting Organization and Brand Marketing teams to consult with and deliver deep insights and actionable strategic and tactical recommendations on access and reimbursement drivers of the business.  Frame and structure approach, analyze and synthesize information, and conduct primary market research to gain deeper brand-specific insights to inform recommendations. Support both marketed brands and pipeline molecules.

• 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

...

The Clinical Specialist, Franchise Sales manages anddevelops long-term relationships with physicians and other customers for thecustomer accounts in the assigned territory. As such, Clinical Specialists represent the assigned GNE brand(s) andtheir approved indications; helping external customers such as physicians,nurses, etc. learn about the benefits of the assigned GNE brand(s) in relationto the applicable therapeutic area/disease state.

 

Reports to: Division Manager, Franchise Sales

 

Example Duties andResponsibilities:

*Responsible for meeting or exceeding assigned sales targets

*Develops robust territory business plans

*Develops strong and long-term relationships with customersin all assigned accounts

*Presents the assigned GNE brands in a professional,compliant, ethical and effective manner; helping external customers understandthe benefits and use of GNE brands

*Monitors operating costs and compliance with territorybudget

*Complies with all laws, regulations and policies thatgovern the conduct of GNE activities

*Business travel, by air or car, is regularlyrequired 
...

Responsible for producinginnovative biotherapeutic medicine by interfacing with highly automatedproduction systems and controls in cGMP manufacturing environment, and maintainareas in high state of inspection preparedness. Operates production equipment for cell culture or purification that mayinclude culture growth, process monitoring, sampling, harvesting, purification,formulation, freeze thaw and transfer.  Performsmedia/buffer solution preparation operations. Maintains records and clean room environment to comply with regulatoryrequirements utilizing current Good Manufacturing Practices (cGMP) and StandardOperating Procedures (SOP).  Responsible for being proficient in two or morefunctional areas and applies expert knowledge of mechanical, scientificprinciples, processes and biopharmaceutical processing equipment.

• Provide coaching and training on best practices and compliance toSOPs.
• Prepare solutions for the production process.
• Participatein continuous operational improvement.
• Providereports to management summarizing goal unit attainment.
• Work with coworkers and supervisor to effectivelytroubleshoot equipment and process issues.
• Understandsthe theory, concepts, and regulations behind biopharm technology andprocesses. 
• Astrong knowledge of at least one manufacturing department with an understandingof process impact of other areas.
• Anticipatespotential problems and takes preventative action.
• Requiresjudgment to know when it is necessary to consult with supervisor and/or supportgroups. 
• Understandshow own actions impact others and uses this information in decision-making.
• Operate systems that clean and sterilizetanks and filtration systems. 
• Prepare solutions for the production process.
• Review documentation and check allcalculations (e.g. tickets, labels, equipment reading).
• Trouble shoot equipment and processproblems.
• Comply with safety requirements, cGMP,SOP and manufacturing documentation.
• Use of automation to perform production operations.
• Provide support to Manufacturing to meet production demands.
• Operate automated systems for equipment operation.
• Assemble and prepare equipment for production.
• Exhibit detail oriented documentation skills.
• Communicate effectively and ability to work in a teamenvironment.
• Exhibit professional interpersonal skills. 
• Work with coworkers and supervisor to effectivelytroubleshoot equipment and process issues.
• All employees with jobs that require access to theWarehouse must be able to pass the Transportation Security Administration (TSA)Security Threat Assessment (STA).
• Follows established safety and environmentalguidelines and procedures for all work performed.  Immediately reports safety and environmentalincidents including injuries, illnesses, near misses, and safetysuggestions.  Fosters a positive safetyculture in which no one gets hurt.
• Operate fermenters, centrifuges, otherharvest systems and protein purifications units.
• Operate and clean fixed tank and filtration systems.
• Operate large scale column chromatography systems.
• Operate small-scale cell culture areas and systems by operatingcleaning, set up, and maintaining 20L batch reefed fermenters; inoculating andmaintaining spinner seed cultures using aseptic techniques, maintaining cellbanks; and performing general seed lab operations.
• Perform CIP and SIP. 

...

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

...

Genentech's Medical Affairs organization' mission is to serve as the bridge between clinical development and clinical practice to support the appropriate utilization and access to all our medicines, by generating and communicating compelling scientific evidence with healthcare professionals and payers. 

• Develop medical strategies based on strong scientific rationale for pre-launch and marketed products in Endocrinology, with a focus on growth disorders

• Establish standards for all Medical Affairs activities, including Sponsored Trials, Supported Trials, Registries and Exploratory Data Analysis of internal and external data bases, publications, medical education, medical communication, Advisory Boards and promotional review.  

• Participate on Franchise Leadership Teams contributing the medical perspective to franchise business strategies and evaluation of new product/development ideas. 

• Work in a cross-functional/matrixed environment, interfacing with Development and Global Medical Affairs personnel to provide the US Medical input into Development programs and Global Medical Affairs strategies

• Responsibility for the medical affairs budgets for the Growth Disorders Franchise to ensure adequate resources and their effective allocation. 

• Interact and manage relations on behalf of Genentech with Key National and Regional Thought Leaders in Endocrinology. 

• M.D. with board certification/eligibility in Endocrinology

Technical/Functional Competencies 

• Relevant therapeutic area experience in Endocrinology (5 or more years, inclusive of academic experience)

• Relevant biotech/pharmaceutical industry experience (2 or more years) strongly preferred

• Considerable experience in the principles and techniques of data analysis, interpretation, and clinical relevance

• Comprehensive understanding of product and safety profiles

Core Competencies / Other Key Behaviors

 

• Participate on cross-functional teams for evaluation of new products/ development ideas and implementation of franchise business strategies.

• Scientific leadership 

• Leading Teams

• Collaboration and Teamwork 

• Excellent Judgment and Analytic skills 

• Drive for Results

• Effective Communication 

• Integrity

• People 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.


...

The Business Solution Manager (BSM) position is part of a global team that supports Product Development Biometrics & Clinical Operations. This role includes working on major cross-functional system initiatives, providing user support, system upgrades/enhancements, and business case development as well as integrating business processes and technology. 

In this role the BSM proactively assesses upcoming changes in Statistical Analysis tools and internal business environments, in compliance with the IT standards/processes and identifies solutions in support of the following areas:

• Epidemiology and Patient Reported Outcomes (EpiPRO)
• Clinical and Non-Clinical Biostatistics (PD, gRED and pRED)
• Thesaurus Management and Coding 

The BSM will also support cross functional initiatives led by other business areas and provide process expertise to support the development of solutions that align with the Product Development Information Landscape & Biometrics Information Landscape roadmaps.

 

In partnership with Biometrics & Clinical Operations, Project Management and Delivery Services, the BSM responsibilities include but are not limited to:

• Development of Roche's Informatics Biometrics & Clinical Operations IT project portfolio in partnership with the customer, project manager and solution architect. 
• Drive harmonization of processes and practices across sites and departments through common standardized data models, applications and technologies that are in line with Roche's strategies and architectures. 
• Providing efficient and effective business processes and practices expertise in a global regulated environment 
• Development of strategies to enable existing Informatics systems to address changing Roche policies and directives. 
• Knowledge of analytical software like SAS and R, especially related to analysis of ‘Real World Data’
• Participating in Roche BSM Forum and collaborate with other BSM's  
• Actively participating in industry groups to understand the future of ‘Real World Data’ and strategy to incorporate in Roche's strategies and solutions.

...

Main Purpose of the Position:
• Direct staff and operations to manage and support multi-site investigations and CAPAs.
• Provide leadership and guidance to staff performing multi-site investigations and CAPA activities for the Biologics OU.
• Establish strategic goals and objectives to achieve department and company
• Manage performance and development of direct reports to ensure achievement of organizational and department goals and a productive environment.

Job Duties/Responsibilities:
• Manage and administer all aspects of people processes related to the employee life cycle.  This includes the selection, hiring and training of personnel on company and department policies, systems and processes.  Manage and communicate compensation related information per company guidelines.
• Coach and develop staff by providing an environment that encourages ongoing personal and professional growth.  Manage and ensure the setting of realistic personal goals for staff and provide regularly scheduled feedback throughout the year.  Ensure staff receives appropriate knowledge and skill development and growth opportunities.
• Interpret, execute and recommend improvements to Quality operational policies, plans and procedures.
• Provide input to department budget and monitor and control expenditures against the department budget.
• Provide input for the development of overall Quality objectives and long-range goals.
• Notify Senior Management of potential quality or regulatory issues that may impact product quality or regulatory compliance.
• Lead and participate in continuous improvement initiatives for Genentech Quality Systems.
• Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.
• Be accountable for behaviors described in the Roche Leadership capabilities.
• Perform any other tasks as requested by Senior Management to support Quality oversight activities.

Technical Duties/Responsibilities:
• Lead a team to manage and support multi-site Biologic investigations and CAPA.
• Support the development and manage the implementation of the Investigator Certification program.
• Sponsor and provide guidance for multi-site investigations and CAPA activities.
• Participate in the Quality review Board
• Develop and report metrics that focus on continuous improvement and ensure an effective and compliant investigation system.
• Partner with Site Quality Heads and other PT groups to with interdepartmental contacts on investigation assessment, resolution, and quality approval.
• Approve Quality Investigation.
• Perform timely escalation to Sr. Management of quality issues potentially impacting products, materials or processes
• Support sites during root cause analysis
• Lead Investigation and CAPA continuous improvement efforts
• Develop short-term goals and long-range plans to ensure effective utilization of Quality resources to support  
• Act as an advisor to internal project teams by providing extensive knowledge of regulatory requirements, industry standards, and company strategy. 
• Provide technical and quality assurance input during the review and approval of applicable documents. 
• Participate in the Quality Review Board.
• Manage the end-to-end investigation process
• Identify, facilitate and establish cross-site and cross-business unit processes to ensure efficient and timely investigation strategies.
• Ensure appropriate application and integration of cGMPs into the discrepancy management system.
• Educate departments on the best practices for conducting investigations and root cause analysis.
• Collaborate with departments to ensure process improvement proposals are practical and feasible.

...

Are you ready to create something that makes a real difference in people’s lives, rather than just a cool widget for the next internet startup?  What about creating tools that enable scientists and engineers to optimize cutting edge biochemical manufacturing processes that produce live-saving medicines for cancer and other unmet medical needs?

We do all of that at Genentech.  We have a small team that utilizes both agile and waterfall approaches (when it suits us) to create novel tools in a biotech manufacturing environment.  We create applications that simply do not exist in this industry – but are vitally necessary to advance the science of delivering new drugs that save lives.

We need someone to help develop and maintain applications in Perl, Ruby, ASP.NET, and some other platforms.  We do not require experience in all of these technologies, only a willingness to learn and expand your toolkit.

You will be responsible for the development and maintenance of the systems you build. You will be required to work both independently and also be part of a team. You are an excellent communicator and have a can-do attitude.

Key Responsibilities:

• Working with small teams, design, develop, test, document and implement GxP solutions based on customer requirements and translate them into functional solutions
• Provide deep technical expertise over a broad set of current technologies and platforms and mentor other team members in these technologies
• Deploy new software enhancements, troubleshoot production systems, contribute to root cause analyses and provide excellent customer service to a 24x7 manufacturing operation
• Work with a variety of in-house developed, commercial off-the-shelf (COTS) and open source software

...

Data Management - Field Operations Manager
Data Management – Field Operations Manager is a subject matter expert and lead contact for FOIM’s IMS sales data support process. The Data Management – Field Operations function is responsible for the processing of quality, accurate and timely sales information used by Genentech Commercial Operations. This is a critical role responsible for working with IMS to ensure accurate and timely data is being delivered to Genentech. Key responsibilities include ensuring product/market definitions, communicating the impact of market events, and data issues to FOIM teams. This role is also responsible for determining and monitoring the Genentech data supplementation process and coordination with IMS to ensure the process runs smoothly. The position requires working closely with internal and cross-departmental teams to ensure sales and customer data meets quality standards for field incentive compensation, reporting and analytics. Timely and clear communications to internal stakeholders is critical. Proactive communication with the broader organization around data or market events resulting in data anomalies is required. A successful candidate will possess advanced business knowledge in pharmaceuticals/biotech and the impact of sales data to quickly understand and identify issues to with focus process improvement. The Data Management – Field Operations Manager will be responsible for operations and projects; that are impacted by IMS data and includes file configurations, definitions, products, recruitment of suppliers, and market and data events that impact data coverage or granularity of the data. Responsibilities would also include coordination deliverables with other teams, attending to ad hoc data requests, and leading and/or participating in special data projects impacting FOIM Data Management – Field Operations. Like other Data Management teams, Field Operations works closely with a host of internal partners, including Genentech’s Commercial Operations Informatics (gCOI), as well as external data or IT vendors/consultants. Incumbents in the Data Management – Field Operations Manager role, as all other employees, are fully accountable for compliance with all laws, regulations and policies that govern the conduct of GNE activities.

1. Compliance, Knowledge & Skills

• 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
• Does not compromise ethics or integrity, or undertake legal risks while pursuing business goals
• Asks questions when in doubt
• Demonstrates leadership among peers and subordinates by consistent application and modeling of the appropriate compliance, behavior and conduct
• If 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. Planning & Development

• Act as a subject matter expert and a lead contact for FOIM Data Management – Field Operations IMS data sources and Genentech supplemented files production processes and projects
• Stays abreast of Commercial Operations and other business developments, to include external marketplace changes/developments, and uses where appropriate data to support recommendations to improve processes
• Recommends new opportunities to his/her manager and other business partners/stakeholders. Where approved, leads the development/implementation process for such new opportunities
• Works with manager, team members, gCOI, others in FOIM, other internal customers, partners and stakeholders and external vendors to review business requirements for Commercial Operations validation and sales data and plan for any new or updated data sources, systems, databases, interface, processing methods and/or reporting mechanisms
• Works with manager, team members and others to develop appropriate departmental plans and goals to address customer requirements. Where applicable, develops detailed project plans and participates in evaluating necessary resources 
• Participates in other planning and development meetings within FOIM and other Commercial Operations groups
• Participates in departmental policies & procedures development, which may include development and documentation of Standard Operating Procedures (SOPs) or other relevant guidelines. May take the lead role in departmental policies & procedures development, as assigned
• As appropriate and assigned, independently leads departmental or customer projects 

...

The Quality Engineering manager works independently and provides oversight of quality engineering activities during design development. Be the quality engineering subject matter expert during device development, manufacturing, technology and associated verification and validation. 

Job Responsibilities:

* Works closely with Device Development and device CMOs to assure that combination products maintain their requirements and specifications and are compliant with the Quality System

* Liaises with technical groups to review and revise specifications based on design and/or process changes

* Supports root cause analysis in the implementation of corrective actions

* Responsible for continual improvement activities and liaises with experts to apply appropriate improvement tools

* Provides technical consultation on the development of fixtures, methods, test equipment, and tooling in order to continually improve process and products 

* Establishes quality inspection processes and supports quality activities to ensure that products and processes comply with the relevant requirements of the quality management system.

* Supports internal/external audits and vendor qualification, including closing out audit findings and determining proper corrective and preventive actions.

* Responsible for planning, organizing, and managing the overall testing activities of quality functions.

* Collaborate on and /or author policies and procedures and act as a trainer / subject matter expert on applicable quality systems, standards or business processes (as required). 

* Set personal performance goals and provide input to departmental objectives and establish work priorities to meet targets and timelines. Maintain current status on all required job related training and strive to continuously improve knowledge and skills in quality, compliance and technology.  Perform any other tasks as requested by Management to support Quality oversight activities

* Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.  

...

Product Manager / Senior Product Manager

The Product Manager, Lytics Cathflo Marketing reports directly to the Group Product Manager and is responsible for:

Management of all peer-to-peer Cathflo programs including speaker's bureau, Cathflo Nurse Trainers, Cathflo Nurse Liaisons and national webinars.
Development of relevant medical education content and patient case studies for inclusion in peer-to-peer programs. Evaluation of nurse thought leader engagement strategy in partnership with the field and other internal partners.
Evaluating new means of marketing broadly to nurses, with a goal of driving an increase in habitual CVAD line assessment. Planning and execution of annual advisory boards in support of Cathflo, as needed. Contribution to the development and execution of the 3-year brand plan, and the 1 year tactical plan for Cathflo.

The successful candidate must have:

• Proven strategic agility in a complex marketplace
• Demonstrated experience in the development and execution of a sales or marketing plan
• Proven ability to partner effectively with field sales and sales leadership
• Considerable skill in influencing without authority
• Ability to provide rationale-based, succinct and persuasive oral & written communications
• Working knowledge of product development, regulatory and clinical affairs
• Demonstrated ability to establish thought leader and other relevant stakeholder relationships
• Strong analytical and project management skills, including previous experience working with budgets and analyzing market research results

...

Purpose:

The senior utilities engineer provides technical leadership and accountability for plant and GMP utilities engineering in the delivery of capital projects and engineering services for research and development (R&D) and quality laboratory, as well as commercial and clinical manufacturing related facilities.

Responsibilities:

• The senior utilities engineer will work effectively on multi-discipline engineering capital project teams, as well as other project related cross-functional teams with representatives from departments throughout the Pharmaceutical Technical Operations and R&D organizations.

• Responsibilities may extend to all regional Americas manufacturing and research facilities, as well as the network of Contract Manufacturing Organizations organized under the Manufacturing Collaborations group.

• The primary area of focus for this position will be the execution of projects from design through commissioning and qualification. The senior utilities engineer will be accountable for:

- Planning and Execution of Projects: including project approach and resource needs, options analysis, utility systems and equipment design, engineering document development, and system ownership through the project delivery phases of plan, design, procure, construct, commission and qualification for research, cGMP and development facilities; and 

- Technical Analysis:  including utility system and technology plant fits, capacity and equipment utilization, value engineering, sustainable design, constructability and assessment of applicable new technologies to balance performance, cost and maintainability.

• Areas of expertise include systems and equipment for purified water, water for injection (WFI), clean steam, process air, process gases and process waste, as well as associated knowledge in plant steam, plant chillers and utility piping.

• This position requires coordination of Genentech/ Roche and/or contract engineering resources.  Facilitating meetings, directing engineering firms and consultants, field supervision, equipment inspection and start-up, construction trade coordination, and training of operational staff are often required.  Success in these areas will depend upon the individual’s ability to effectively communicate, collaborate, and foster positive interactions with team members, while diligently managing adherence to project scope, budget and schedule.

• The senior engineer is expected to be an effective communicator of ideas, project goals and results.  With minimal supervision, is expected to make presentations and updates to senior management and in broader forums both internal and external to Genentech. 

• The senior engineer is expected to contribute to increasing the efficiency and effectiveness of the Engineering Technology department by contributing toward infrastructure improvements to guidelines, procedures, practices, standards and cross-functional business processes.  The senior engineer should share insights and improvements, participate in design reviews across the portfolio of departmental projects, and contribute to best practice forums across our network of global engineers and partners. 

...

HCV Clinical Specialist
Territory: Richmond, VA and Virginia Beach, VA areas


The HCV Clinical Specialist, Pegasys Sales manages and develops long-term relationships with physicians and other customers for the customer accounts in the assigned territory. As such, Clinical Specialists represent the assigned GNE brand(s) and their approved indications; helping external customers such as physicians, nurses, etc. learn about the benefits of the assigned GNE brand(s) in relation to the applicable therapeutic area/disease state.

Reports to: Division Manager, Pegasys Sales

Example Duties and Responsibilities:
• Responsible for meeting or exceeding assigned sales targets
• Develops robust territory business plans
• Develops strong and long-term relationships with customers in all assigned accounts
• Presents the assigned GNE brands in a professional, compliant, ethical and effective manner;
helping external customers understand the benefits and use of GNE brands
• Monitors operating costs and compliance with territory budget
• Complies with all laws, regulations and policies that govern the conduct of GNE activities.

...