MSL-Oncology

The states covered are Arizona, New Mexico, San Diego, Orange County, and Southern Nevada

Main Purpose of the Position:
The Genentech, Inc., Medical Science Liaison (MSL) functions as a field based member of the Medical Affairs organization. MSLs are scientifically trained professionals with strong clinical and / or scientific backgrounds. MSLs are expected to facilitate and implement the clinical strategies of Medical Affairs through:
* Relationship development
* Clinical trial support
* Scientific/clinical education and communication

 

Job Duties/Responsibilities:

General:
*Adhere to corporate compliance in all activities, including those related to clinical trials, scientific presentations, and responses to unsolicited requests for information.
*Maintain clinical, scientific, and technical expertise in specific therapeutic areas; review scientific journals, attend scientific and key technical meetings.
*Represent the Medical Affairs organization to investigator community
*Maintain ongoing long-term collaborative relationships with investigator and thought leader communities

 

Clinical trial support: MSLs interact with Genentech Medical Directors and their designees to determine and coordinate health care practitioner, researcher, and investigator activities.. MSLs act as the conduit between external customers and the Genentech Medical Directors.

 

Customer/Investigator support:
*Respond to and document unsolicited requests for information on our marketed products and products in clinical development
*Represent Genentech products at medical information exhibits during scientific symposia.
*Facilitate investigator and thought leader interactions with GNE Medical Directors

 

Commercial support:
*Provide internal clinical input and training to Commercial functions within regulatory guidelines
*Provide clinical and scientific support for Advisory Boards
*Content development/scientific review of content and presentation materials, upon request

...

The Position: Accountable for managing a multi-discipline technical group responsible for performing a variety of routine and complex activities under cGMP regulations and standards. The team’s primary responsible is providing technical support for upstream manufacturing operations to ensure reliable delivery of drug substances to the global supply chain. Manage performance and development of direct reports to achieve organizational and department goals in a productive work environment. Develop solutions to complex issues and key Technology initiatives. Establish work priorities and timelines in alignment with project and department needs. Form productive relationships with individuals and groups across the Vacaville site including but not be limited to; Manufacturing, Science and Engineering groups, Validation, Facilities, and Quality Assurance.

Responsibilities and Job Duties: The successful candidate will manage and administer all aspects of personnel performance and staff development. This includes 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 development. Manage and ensure the setting of realistic goals for staff and provide regularly scheduled feedback throughout the year, including workload balancing. Recommend and implement improvements to Technology policies, plans, and procedures. Manage routine department activities and Technology initiatives, ensuring completion of activities and initiatives on time and within budget. Serve as USFL representative on cross-functional teams and at senior level meetings. Oversee and direct timely resolution of complex issues through effective interdepartmental and cross-functional partnerships. Clearly and effectively communicate and present complex ideas and concepts to all levels within the company. Establish and communicate strategy, vision and direction for their team.

 

Technical Responsibilities: The successful candidate will be responsible for managing a diverse team comprising a variety of technical disciplines and skills levels, including Automation, Manufacturing Sciences, Process Engineering, and Validation.  The candidate will oversee technical cross-training efforts, act as a mentor, and provide technical career guidance. Provide technical leadership while fostering teamwork in a GMP environment across functional and organizational boundaries. Communicate proactively with stakeholders and senior management regarding progress, issues, and plans for resolution. The candidate must effectively manage their team in two areas;

·         Immediate resolution of emergent issues including troubleshooting process, equipment and system malfunctions or failures on a 24/7 basis. Daily process monitoring and analysis of manufacturing data, support for discrepancy investigations, and identification/implementation of immediate corrective or preventative actions to ensure continued compliant operation.

·         Support and/or lead identification and implementation of near and long term changes including; analyzing and solving process performance problems, root cause analysis, and ownership/sponsorship of CAPAs. Support and/or lead a variety of capital and expense projects ranging from design, implementation, and startup. Develop solutions to complex problems which may require highly innovative and ingenious approaches.

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This position will support cell culture process development projects in the Late Stage Cell Culture Department, including characterization and validation studies. The candidate will be responsible for designing and executing lab bench-scale experiments (bioreactors, shake flasks, etc.), coordinating and supporting pilot plant experiments, analyzing data, and summarizing the results in technical documents and oral presentations. He/she will also be expected to contribute to the identification and evaluation of cell culture technology development projects and may represent cell culture on multidisciplinary project teams and task forces. He/she will be required to author internal technical, characterization and validation documents as well as deliver high quality scientific presentations to the lab group, department and externally.

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

 

RESPONSIBILITIES:

 

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

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The Senior Clinical Coordinator, Franchise Sales bringsclinical knowledge and expertise to the assigned franchise sales team.  The Senior Clinical Coordinator helpsclinical specialists and their customers increase their knowledge andunderstanding of the assigned GNE brand(s); their benefits and use as thesepertain to the relevant therapeutic area/disease state and approvedindication(s).

 

Reports to: Clinical Coordinator Field Manager

 

Example Duties andResponsibilities:

*Participates in territory/division/regional businessplanning

*Recommends opportunities to increase account knowledge ofGNE brand(s)

*May provide input into marketing materials

*Actively participates in local clinician groups

*Provides training and education sessions regarding GNEbrand(s) and their approved indication(s). Uses approved training/education materials

*Supports clinical specialists in other ways/means byattending periodic account meetings; helping to further increase accountknowledge of GNE brand(s)

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

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

Sales Compensation Administration - Analyst / Manager

The Sales Comp Administration - Analyst / Manager role is to support the Sales Operations Incentive Compensation team for all business units / sales forces in administering Sales Incentive Compensation Programs which includes ad hoc analysis and reporting. As such the Sales Comp Administration - Analyst / Manager will be responsible for all sales compensation administration aspects including the maintenance of all sales force reference data, variable pay information, and compensation plan information within the compensation systems (TrueComp) and Incentive Compensation platforms. Additionally they will work with the Business Unit Comp Managers to collect plan design information and be responsible for the oversight of development and testing of compensation plans and rules in TrueComp. He/She will support and maintain the monthly sales and goal validation process, which requires critical thinking and problem solving skills. Candidate will also manage department SOPs, prepare department activity timelines, maintain documentation for various purposes such as program policies, eligibility, auditing & OCM purposes. Candidate will also support multiple supplemental incentive programs including the management of processing guidelines to ensure accuracy and consistency including application design & management. He/She will also help manage awards program documentation, criteria, history, inventory, etc. He/She will maintain content on IC Portals and facilitate process/data management with vendors. Candidate must have SQL skills for querying data and a basic understanding of sales compensation philosophy. Candidate will proactively coordinate with internal partners to ensure data accuracy, optimize operational processes and meet aggressive timelines. Provide adhoc support and analysis, including running queries and producing reports (using Access, Brio, Toad or other sql tool). Strong technical, stakeholder manager and communication skills are required.

 

Key Responsibilities:

 

- Primarily responsible for the administration and management of all sales incentive compensation administration deliverables including oversight of system configuration for IC plans, reference data (e.g. eligibility), timely and accurate payout processing, supplemental incentive programs, reporting and reference data management for all brands.

 

- Partner with Sales Operations Managers, Vendors and/or the Information Technology team to define data and reporting needs in support of the IC payout process and supplemental incentive programs.

 

- Collaborate with various internal and external stakeholders to ensure fairness and consistency in the implementation of and adherence to program policies.

 

- Communicate with field sales management in support of the sales incentive program payout process and provide supplemental incentive programs summaries.

 

- Development communication and reporting materials to support IC administration activities and status reports.

 

- Comply with all laws, regulations and policies that govern the conduct of GNE activities....

 Responsibilities:

This position is for a Principal Engineer/Principal Manufacturing Technical Specialist reporting to the Associate Director of Technology Validation in the South San Francisco Production Technology Department.  The candidate will independently lead highly complex compliance and transformational validation program projects.  The candidate will also be expected to lead site implementation of complex multi-site CAPAs and quality system deployments.  These projects require close collaboration with site Manufacturing, MSAT and Quality and other functions as well as network colleagues and corporate quality functions over the course of multiple years.  This candidate will sit on the Technology Validation Leadership Team and will assist the Associate Director in developing group goals and development plans.  The candidate must provide mentorship and direction to staff on interpretation of the Roche Quality System requirements, execution of the Qualification Lifecycle and Qualification Strategies for highly complex projects.  This candidate will also be responsible for representing Genentech in agency inspections and audits.  They will participate in network teams developing quality system approaches.

...

The Position

We have an opening for a bioinformatics scientist to support development, regulatory, and discovery needs for infectious disease therapeutics. These include deep sequencing of viral and bacterial pathogen DNA from clinical trials to discover and analyze resistance mutations, analysis of host-pathogen interactions in clinical samples and preclinical models, and genomic analysis of both individual bacterial species and bacterial communities. Contribution to regulatory filings will be expected. Close interactions with bioinformatics and infectious disease scientists will be required to achieve these goals. The successful candidate will become an important member of teams developing breakthrough and life-saving therapies. High levels of drive, innovation, attention to detail, independence, and accountability will be required for success, along with flexibility to work with diverse teams that encompass all aspect of drug development. There will be opportunity and expectation to develop new computational methods, discover fundamental new understand and actively publish research results.
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The Project Manager position will work in the Operations & Business Infrastructure function and is responsible for planning, executing, evaluating projects according to predetermined timelines & budgets, and ensuring quality control throughout project life cycles. The primary responsibilities include, but are not limited to, the following:

• Provide business and project management support across a broad range of projects in Medical Affairs with primary focus on providing support to the Field Medical Teams (FMT)
• Build and manage the FMT Strategic and Operational Plan, working with key internal stakeholders to enable effective evaluation of current gaps, future needs, prioritization and resource alignment/allocation
• Perform project budget and work plan reviews, project alignment and prioritization activities and resource utilization analyses
• Partner with IT function and/or work with project sponsor and stakeholders to complete project charter outlining scope, goals, deliverables, required resources, budget and timing
• Responsible for driving and delivering the project on-time & within budget and meeting the strategic business needs through effective project management methodology/principles
• Manage project scope, resources and stakeholders expectations/requirements
• Develop systematic approach, ongoing improvements and innovations to enhance performance in problem solving and project management
• Build coalitions among the various stakeholders and negotiate authority to move projects forward
• Proactively engage stakeholders throughout the project to gain their commitment, agreement and support on the proposed solutions, priority setting and implementation
• Consult and provide advice; facilitate discussion and resolve conflict; establish trust, build and use cross functional relationships to accomplish work objectives
• Advocate on behalf of stakeholders to negotiate with service provider (e.g. vendor and/or IT function) to ensure proper solutions meet the business strategic objectives
• Facilitate and lead all aspects of organizational changes for the assigned project responsibilities
• Communicate and/or present project timeline, risks, and overall status to the business functional leaders, senior managers, all appropriate stakeholders, and project team members
• Establish timely and proper communications to business sponsor and stakeholders that includes centralizing projects activities & information via dashboard or other mechanism
• Make decisions and take timely independent action in pursuit of priorities

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Main Purpose of the Position: Solve a wide range of challenging issues that impact multiple functions by managing change records in accordance to cGMP regulations and Genentech standards. Manage staff performing a variety of routine and complex change control activities to meet cGMP regulations and Genentech standards. Perform assigned tasks and manage performance and development of direct reports to ensure achievement of organizational and department goals objectives. 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 development. Manage and ensure the setting of realistic goals for staff and provide regularly scheduled feedback throughout the year. Ensure staff receives appropriate knowledge and skill development and growth opportunities. Set operational objectives for staff. Follow company policies and procedures. Help maintain a state of inspection readiness. Lead and participate in improvements to Quality operational policies, plans and procedures. Manage routine department activities and complex Quality initiatives. Ensure completion of activities and initiatives on time and within budget. Serve as the Quality representative on cross-functional and multi-site teams. Identify, design, and implement process and system improvements. Lead and participate in the design and implementation of department and cross-functional initiatives. Apply advanced theory, technical principles, and expert judgment to address a broad range of difficult problems. Troubleshoot and direct 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. Train personnel on relevant business processes. Be accountable for behaviors as described in Roche’s Core Competencies. Technical Duties/Responsibilities: Function as a Change Controller by assessing, reviewing, approving and closing change records. Ensure the management of lot release restrictions imposed by system, process, method and equipment changes. Author, edit, word process, and release controlled documents relating to Quality Systems. Provide training to new employees and internal customers on policies and procedures for the Change and Document Control systems. Facilitate and contribute to cross-functional change management forums. Recommend change control strategies that have minimal impact of validated systems and qualified equipment. Lead business process improvement and process redesign initiatives. Collaborate with departments to ensure that all review activities are executed efficiently and effectively. Support periodic audits and regulatory inspections. Develop and implement systems to ensure inspection readiness. Provide data for departmental performance metrics. Serve as a Quality representative on cross-functional and multi-site teams. May be required to support other Quality Systems & processes such as Document Management, CAPA, Product Complaints, Annual Product Reviews. Support internal and partner audits, and health authority inspections....

A Scientist position is available in Protein Analytical Chemistry (within US Biologics Pharma Technical Development, PTDU).  Responsibilities will include analytical characterization of recombinant proteins – primarily monoclonal antibodies and antibody-drug conjugates - using techniques such as high-performance liquid chromatography (HPLC), mass spectrometry (MS), and capillary electrophoresis (CE).  This will include development, optimization, and validation of analytical methods to be used for characterization and/or quality control of therapeutic protein candidates.  The individual will provide analytical support to different functional groups in PTDU and actively participate in project teams consisting of members from all areas of process development. The individual may be responsible for managing 1-2 research associates, depending on experience level....

Job Responsibilities:

Reporting to the manager of the Automation Systems group, the Systems Administrator is responsible for development and support of IT infrastructure and vendor application software associated with mission-critical automation systems, including the Building Automation System (BAS), Utilities Control System (UCS), Programmable Logic Controllers (PLCs), and Vendor Supplied Controllers (VSCs). Specific responsibilities will include:

• Perform GMP maintenance activities on automation systems, including monitoring, physical and logical security, backups, and change control
• Respond to system issues (including 24x7 on-call support); Troubleshoot and remediate issues
• Complete discrepancy, investigation and CAPA records as required
• Install operating system and vendor software patches and upgrades; Design and implement hardware upgrades, system expansions and enhancements
• Support site and network projects that involve system changes
• Perform periodic reviews and revalidations according to quality standards and validation protocols
• Assess and manage risks associated with system operation and use, and design and implement improvements
• Support site audits and inspections, and implement corrections as needed
• Maintain system documentation and life cycle support strategies
• Manage vendor support contracts to ensure delivery of products and services, and process renewals to ensure continuous coverage

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Position Purpose:

• The Senior Regulatory Global Project Manager is expected to serve as a strategic partner with Global Regulatory Leaders (GRLs), work with the GRL and the cross-functional global filing team members to define regulatory filing strategy, convert the strategy into an executable plan, and facilitate flawless execution of the plan to enable successful global filings and Health Authority interactions;
• Applies project management methodology and disciplines to improve the efficiency and effectiveness of the global filing team;
• Contributes to the efforts of building templates, tools and processes to optimize filing team performance;
• Serves as business partner for the assigned TA (Therapeutic Area) in PDR, working closely with the TA Head, brings excellent project management service offering to the TAs, and also bring TAs’ request/feedback to the Regulatory Business Excellent (RBE) to help further optimize the performance and service offering by RBE.

Major Responsibilities and Accountabilities:

• Provides appropriate level of Project Management service, and tactical leadership to multiple global filing teams based on the agreed scope of work and business need;
• Takes accountability for all project management aspects and works effectively and closely with the GRL or Team Leader;
• Drives creation and updates of a high quality filing timeline using MS Project with clearly defined activities, interdependencies, duration, task owners and planning assumptions; collaborates closely with the GRL and team members to coordinate, prioritize and aligns team’s activity in support of the project plan and ensure a structured approach to activity execution, and the efficient utilization of resources;
• Actively tracks the progress of the deliverables, and partners with GRL to create reports and trackers to ensure clear and transparent communication to key stakeholders;
• Works closely with team to identify and manage the activities which are on critical path and the critical activities that have the potential to become critical path activities; identifies the potential risks that could impact the timeline and PTS of a filing, and work with team to define a mitigation plan;    
• Effectively facilitates filing team meetings with high quality meeting agenda and minutes;
• Maintains an action item tracking log, drives the completion of the action items, and documents the resolution of the action items;
• Facilitates team communication, monitors the activities of the project team to ensure constructive team dynamics, effective communication and progress in conformance with project scope and timelines;
• Maintains proper online documentations of filing related project documents;
• Assists GRL on preparation, organizing and conducting lessons learned sessions post filing;
• Through support of the projects, identifies near-term improvement opportunities to leverage and/or enhance PDR PMO’s project management knowledge, process, tools, and templates to potentially increase efficiencies, accelerated activities and standardize processes.

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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

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The USMA Manager of Systems and Processes works closely with the business to define strategies for development, implementation and improvement of core business processes and workflows to support the business needs in alignment with local regulations and corporate policies. This includes defining current processes, establishing mechanisms to identify process gaps and develop solutions, establish quality control measures for processes and system data, and coordination of process and quality improvement projects. The Manager of Systems and Processes is responsible for analyzing, refining and developing processes through to implementation and beyond to support decision making by USMA management.

Job Duties/Responsibilities:

• Organize and facilitate teams to critically review current business processes for quality, simplification and effectiveness and to identify requirements requiring cooperation and support from cross-functional stakeholders/business partners, establishing links between business strategy and process improvement initiatives and use of systems.
• Develop procedural documents, working documents and clinical study manuals in compliance with regulatory requirements and global processes.
• Routinely prepares reports by collecting, analyzing and summarizing information to support portfolio planning and study management activities and decisions.
• Collaborates with local or global reporting teams to create USMA specific reports to ensure accurate data is reported to management and enable good business decisions to drive business success.
• Collaborates with USMA stakeholders and other business partners to ensure appropriate documentation and integration in to process maps.
• Regularly attend cross-functional staff meeting to present system and processes project and process improvement activity status.
• Represents USMA on global systems/processes initiatives contributing to maximize functionality and ensuring alignment.
• Serve as internal advisor to address systems/process related questions and gather information to distinguish requests from true business needs.
• Develops tools, templates and procedural documents to support the tactical application of business processes as required.
• Routinely solicits feedback from users on systems and process enhancements, training and other ways of driving more effective systems/processes integration.
• Provides input to training programs and team effort by accomplishing related results as needed.

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Responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment, and maintain areas in high state of inspection preparedness. Operates production equipment for cell culture or purification that may include culture growth, process monitoring, sampling, harvesting, purification, formulation, freeze thaw and transfer. Performs media/buffer solution preparation operations. Maintains records and clean room environment to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP).

Responsible for assisting the shift supervisor by ensuring production goals are met throughout the day and distributing work assignments to technicians.

Job Responsibilities:
Lead TechnicianLead, coordinate and assign daily operations that include work tasks, breaks, and lunches. Provide coaching and training on technical aspects of the job, best practices and compliance to SOPs.

Assist Supervisor with meeting production quality standards by verifying the environment is in compliance with safe standards and SOPs are followed. Assist supervisor with approvals, communications, and improvements. Identify areas for operational improvement. Provide data to supervisors summarizing schedule status. Resolve employee conflict independently and with supervisor.

Job Matrix
Through knowledge of biopharm technology, processes and the underlying scientific concepts.
Must demonstrate a comprehensive understanding of both general and specific aspects of multiple manufacturing departments.
Troubleshoots, investigates, and escalates complex problems, works with others to implement solutions.

Technician: Operate systems that clean and sterilize tanks and filtration systems.
Prepare solutions for the production process.
Review documentation and check all calculations (e.g. tickets, labels, equipment reading).
Trouble shoot equipment and process problems.
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 team environment.
Exhibit professional interpersonal skills.
Work with coworkers and supervisor to effectively troubleshoot equipment and process issues.

Supplementary Responsibilities
Operate fermenters, centrifuges, other harvest systems and protein purifications units.
Operate and clean fixed tank and filtration systems
Operate large scale column chromatography systems.
Operate large scale UF/DF and Freeze Thaw systems.
Operate small-scale cell culture areas and systems by operating cleaning, set up, and maintaining 20L batch feed fermenters; inoculating and maintaining spinner seed cultures using aseptic techniques, maintaining cell banks; and performing general seed lab operations.
Perform Solution Preparation activities (media and buffer make-up)
Clean, assemble, and sterilize equipment using glass washers and autoclaves.
Perform automated CIP and SIP of fixed equipment.

...

Main Purpose of the Position:    

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

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

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

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

Technical Duties/Responsibilities:

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

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

·         Provide input in the preparation of regulatory submissions.

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

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

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

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

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

·         Execute Airflow Visualization studies and create summary reports.  

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

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

·         Ensure department representation on relevant project teams.

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

·         Communicate group performance against established metrics to Quality Management.

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Position Summary:

Provide Project and Program Management for IT business solutions that have significant impact to the enterprise in North America ERP Demand to Supply, Manage Finance, and Order to Cash solutions.

The position will work closely with the North American ERP organization to plan, manage and deliver process and system initiatives. As a senior project manager this individual will lead the deployment of SAP systems and processes across Pharma in the North American region. Responsibilities include future SAP site implementations, enhancements, functional transformation projects and infrastructure related projects.

This position provides expertise needed to effectively implement projects and continuously improve processes. This individual will also partner with business project managers while working with the Pharma IT organization to drive requirements and successfully complete projects.

The purpose of the department is to a) provide IT services for the NA regional ERP solutions, b) deliver enhancements and projects for the regional ERP solutions, c) ensure the services are delivered to established customer SLAs, and d) provide a local/regional presence for the ERP IT group.

2-3 most important contributions of this department

Understand the local and regional business needs for the ERP solutions. 
Deliver operational services for the regional and local Demand to Supply, Manage Finance, and Order to Cash solutions.
Deliver enhancements and projects for the Regional Demand to Supply, Manage Finance, and Order to Cash solutions.

Main customers are the regional/local Finance group, regional/local Tech Ops group,  Local Order to Cash group.

Main PI collaborations are with ERP Architecture, global ERP Solution Owners, Business Project managers, IT Application Technical Leads,  AE&O.

Major Responsibilities:

• Developing work plans, managing deadlines and coordination of project team and sub-team activities
• Estimating project skill requirements, and then working with resource deployment managers to identify appropriate resources and manage their integration into the team
• Defining and agreeing on deliverables , risk management and milestones
• Setting and controlling scope
• Communicating status and vision to client management and stakeholders
• Create a collaborative environment which promotes communication across the organization, at all levels: including but not limited to the Steering Committee, Enterprise Architecture, Departmental Managers and Information Technology.
• Provides overall team management, including regular evaluations
• Prepares and delivers executive presentations and facilitates workshops/meetings.
• Ensures procurement and sourcing procedures are followed.
• Provides Functional Manager with feedback on team member performance.

...

Responsibilities:

The Safety Assessment Division of Genentech is seeking a toxicologist with 0-3 years experience in general toxicology and an interest in human health risk assessment. This position will report to the Director, Product Quality and Occupational Toxicology.

The Associate Scientist will conduct analyses of available data and generate documentation to provide guidance for decision making to product quality, product process, drug development, and environmental health and safety (EH&S) teams. Examples of specific duties include conducting health-based risk assessments for active pharmaceutical ingredients (small and large molecule), process-related impurities, process residues, extractables and leachables, and small molecule intermediates. Additional duties involve the evaluation, interpretation and communication of available scientific information for active pharmaceutical ingredients and incorporation of these data into documentation in compliance with hazard communication requirements, the development of occupational exposure limits (OELs), and MSDS maintenance for Genentech's products in collaboration with EH&S. This is an excellent opportunity to gain
early entry to an industry position with a company that develops novel proteins and small molecules for the treatment of unmet medical needs.
...

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.

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