Clinical Specialist
NY Metro Territory

The Clinical Specialist, Franchise Sales manages and develops long-term relationships with physicians and other customers for the customer accounts in the assigned territory in the Hospital/Critical Care setting. 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, Franchise 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
*Business travel, by air or car, is regularly required

...

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 Position

Senior Finance Manager/ Finance Manager commensurate with experience

JOB DESCRIPTION:

Position is dedicated to supporting the financial management of the Oceanside Product Operations, part of the Roche Biologics Operating Unit (OU). The position will report to the Site Finance Head for Oceanside and is part of the Pharma Technical Operations Finance group, which is charged with the financial stewardship of Genentech's Technical Operations organization.  Beyond delivering on core job objectives, the position will have the opportunity to extend and lead other site and global network initiatives.

MAJOR RESPONSIBILITIES:

Responsible for the financial planning, analysis, and reporting activities of the Oceanside Drug Substance Manufacturing operations.  Act as a key Finance business partner to the functional heads of the operations and quality organization.  Develop strong business acumen and partner with the OU to help guide the business functions and support business and financial analysis.

Planning and Analysis

• Lead execution of planning exercises (forecasts, budgets, long-range plans) and coordinate efforts with business partners to prepare operating expense, headcount, and capital forecasts so that all submission requirements and deadlines are met. 
• Analyze budget forecast proposals for strategic consistency and suggest modifications as appropriate. 
• Provide support for all budget reviews and submissions. 
• Identify and execute opportunities to improve operational results. Partner with OU management to achieve targeted costs and continuously improve. 
• Analyze spending and cost of production monthly and provide direction to OU management to balance risk and cost targets.
• Develop financial decision frameworks for operational issues and lead analysis through final recommendation. 
• Work with OU functions to provide input on the development and tracking of appropriate metrics and goals for planning horizon.
• Lead business case analysis for site and network initiatives.

Reporting

• Perform efficient and pertinent month-end reporting, including investigation of spending and manufacturing variances. 
• Prepare and present monthly financial results to site and financial leadership. 
• Use financial reporting to direct OU management toward areas of improvement or to surface operational issues. 
• Prepare and present quarterly capital spending updates to site and Technical Operations leadership. 
• Support Site Capital Governance Team in Capital Reporting, Planning and Financial Analysis. 
• Business Partnership
• Be a strong business partner to Operations function heads, learn and help navigate the business using finance metrics, results and KPIs as tools.
• Support site team governance structure with standing membership of SMART, IMPACT, JMT teams.
• Drive continuous improvement and risk mitigation projects in partnership with functional leaders.
• Financial Management & Controls
• Perform month-end close activities, including monthly production activity, cost allocations and reconciliation of inventory balances. Identify, investigate, and resolve potential issues within tight time constraints. 
• Manage and control expense and capital transactions through the corporate accounting system (SAP BW) including maintaining and reconciling accrual transactions. 
• Communicate effectively with internal finance departments, including Vendor Finance, R&D Finance, Capital Finance, Corporate FP&A and others to ensure quick and accurate resolution to financial issues. 
• Support and direct Internal Control audits.
• Monitor compliance to corporate financial controls and code of ethics.

MAJOR SKILLS AND BEHAVIORS:

• Demonstrated analytical acumen and problem-solving skills. 
• Independent self-starter and proactive leader. Seeks to continually improve business processes and add value. 
• Strong communication and presentation skills and demonstrated success building partnerships across organizational boundaries.
• Commitment to customer service with a strong sense of ownership for projects and results. 
• Must be able to work in a fast-paced environment that often requires commitment of more than 40 hours week.
• Good business acumen and strategic thinking.
• Ability to work collaboratively as a team with business partners.
• Ability to stand in for Site Finance Head and  work with senior leadership team as needed.

...

Conduct repetitive, predictive, condition based, reactive maintenance and troubleshooting of cGMP production equipment, clean utilities and plant utility systems. Assist with engineering and evaluation of existing and new equipment and processes. This is a Journeyman level position.

• Conduct general preventative maintenance according to SOPs/work instructions and perform planned and unplanned repairs as necessary.
• Conduct routine inspections and monitoring of equipment and systems and documenting systems operating parameters.
• Make appropriate adjustments or modifications within company and GMP guidelines and notify supervisor of any abnormal parameters.
• Lead and organize specialized maintenance and equipment projects. Includes research of methods and devices, assisting with implementation and documentation of change control.
• Provide general labor services throughout all areas maintained by the Maintenance department.
• Responsible for providing data to derive performance metrics for management that will be gathered on a daily basis for monthly reporting.
• Provide technical expertise and training to junior staff.
• Assist as technical SME with identification, purchase, and organization of spare parts.
• Successfully complete training and demonstrate an ability to perform equipment monitoring and operational checks on manufacturing and utilities equipment.
• Cleaning and organization of designated work areas in Manufacturing and Utilities.
• Complete GMP and other controlled documentation.
• Revise or modify existing SOP documentation as necessary and be expected to write new procedures for new equipment and other duties as assigned by management.
• Interact with Manufacturing, Instrumentation, Metrology and Engineering staff members as well as other internal/external customers.
• All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
• Follows established safety and environmental guidelines and procedures for all work performed.  Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions.  Fosters a positive safety culture in which no one gets hurt.
• General Duties: Master Level PM and Repairs of process equipment and systems such as Fermentors, Centrifuges, Mixers, Autoclaves, Washers, Pumps, Agitators, Mechanical Seals, Control Valves, Steam, Hydraulics, Pneumatics, Electrical Controls, Chilled Water, High Purity Water, Compressed gases etc.

...

• Primarily accountable for ensuring the technicalsuccess of the maintenance  operations and the performance management of aworld-class maintenance  organizational unit associated with thecommercial manufacture of all GMP products.  
• Manage activities of designated functional unit inmaintenance  shift or unit supervisors/leads who direct daily activities.  
• Identify the technical, procedural andequipment issues that may compromise production and compliance, working closelywith cross-functional groups to identify and implement solutions.
• Manage and resolve technical andcompliance issues with Quality, Manufacturing, Manufacturing Sciences andTechnology, Reliability Engineering, Engineering, & EH&S.
• Develop weekly and monthly goals andschedules and set priorities for supervisors/leads. Evaluatesupervisors’/lead’s performance; ensure supervisors’/lead’s fair and timelyevaluation of the performance of their staff.
• Responsible for identifying andimplementing improvements in staff development in areas such as cGMP training,technical skills, safety, performance management.
• Implement and follow through oncorrective and preventative actions for variances.
• Represent the department in reviewingand approving all maintenance related documentation requiring approval such asprocess validation protocols and final reports, planned and unplanned variancereports, documentation change requests, engineering and facility changerequests, and validation protocols.
• Ensure that all operations areperformed with 100% compliance to documentation cGMP standards.
• May prepare department budgets andstrategic staffing plans.
• Assist Associate Director with settingbusiness goals and cross-functional deliverables.
• All employees with jobs that requireaccess to the Warehouse must be able to pass the Transportation SecurityAdministration (TSA) Security Threat Assessment (STA).
• Promotes a safety culture that supportcontinuous improvement in the EHS management system through activecommunication and functional area participation in site safety teams ensuringthe safe and efficient operation of assigned functional areas and activities. Fosters a positive safety culture in which no one gets hurt.
• Manage assignments that are complex innature where independent action and a high degree of initiative are required inresolving problems and developing recommendations.
• Manage problems where analysis ofsituations and data requires an evaluation of intangible variables.  
• Exercisesindependent judgment in developing methods, techniques and evaluation criteriafor obtaining results.

...

Conduct repetitive, predictive, condition based, reactive maintenance and troubleshooting of cGMP production equipment, clean utilities and plant utility systems. Assist with engineering and evaluation of existing and new equipment and processes. This is a Journeyman level position.

• Conduct general preventative maintenance according to SOPs/work instructions and perform planned and unplanned repairs as necessary.
• Conduct routine inspections and monitoring of equipment and systems and documenting systems operating parameters.
• Make appropriate adjustments or modifications within company and GMP guidelines and notify supervisor of any abnormal parameters.
• Lead and organize specialized maintenance and equipment projects. Includes research of methods and devices, assisting with implementation and documentation of change control.
• Provide general labor services throughout all areas maintained by the Maintenance department.
• Responsible for providing data to derive performance metrics for management that will be gathered on a daily basis for monthly reporting.
• Provide technical expertise and training to junior staff.
• Assist as technical SME with identification, purchase, and organization of spare parts.
• Successfully complete training and demonstrate an ability to perform equipment monitoring and operational checks on manufacturing and utilities equipment.
• Cleaning and organization of designated work areas in Manufacturing and Utilities.
• Complete GMP and other controlled documentation.
• Revise or modify existing SOP documentation as necessary and be expected to write new procedures for new equipment and other duties as assigned by management.
• Interact with Manufacturing, Instrumentation, Metrology and Engineering staff members as well as other internal/external customers.
• All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
• Follows established safety and environmental guidelines and procedures for all work performed.  Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions.  Fosters a positive safety culture in which no one gets hurt.

...

This is a term position for approximately 9 months

Responsible for implementing and maintaining the validated state of automated systems at Genentech’s Oceanside Facility. Expected to be knowledgeable of and work within GMP regulations.  Requires protocol generation, execution, data analysis, troubleshooting skills, deviation investigation and protocol report closure for the site.  Responsible for validation contractor oversight, demonstrating leadership skills and modeling Genentech values and core competencies while working closely with Engineering, MSAT, Quality Assurance and Manufacturing.  This position requires strong communication and collaboration skills, the ability to work within teams, facilitate meetings and lead teams.  

Job Responsibilities

Essential

Manage and track the Validation program and assigned validation projects for automated systems and ensure target timelines are met and/or issues are communicated / escalated effectively and consistently.
Generate, review, approve and maintain Qualification Project Plans and Summary Reports and other validation lifecycle documents for automated systems.
Generate, review and approve a variety of Validation protocols (IQs, OQs, IOQs, PQs) for automated systems.
Manage protocol execution, perform data review and manage deviation resolution.
Oversight and management of validation contract resources including work prioritization, execution and contractor budget.
Strong understanding of commercial production environment and requirements.
Evaluate and audit the current validated status of automated systems.  Make suggestions for improvements as well as ensure system is operating in compliance and validated state.
Present validation packages for automated systems as required for audits and/or regulatory inspections.
Perform role of subject matter expert and assess change control and discrepancy events for automation systems.
Review automation validation lifecycle documents for compliance with CFRs, corporate requirements, and site procedures.
Lead group of Subject Matter Experts through the Quality Risk Management process and prepare Risk Management Reports documenting system risks, applicable remediation/risk reduction and critical controls.
Participate in cross-functional team meetings and where required, lead/facilitate meeting.
Review validation lifecycle documents for compliance with CFRs, corporate policies (QP/QS documents), and site procedures (SOP’s).
Participate in cross-functional team meetings and where required, lead/facilitate meeting.
Ensures there will be 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 their functional area.

...

Clinical Specialist

Territory: Central Illinois (including Springfield, Peoria, Quad Cities)

The Clinical Specialist, Franchise Sales manages and develops long-term relationships with physicians and other customers for the customer accounts in the assigned territory in the Hospital/Critical Care setting. 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.

The applicable therapeutic area / disease states are: Acute Ischemic Stroke¿and Central Venous Catheter Management and Reports to: Division Manager, Franchise 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
• Business travel, by air or car, is regularly required

NOTE: This position requires significant use of either a company provided or personal vehicle to perform the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business.

...

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.

...

PTR Regional Hub Sr. Regulatory Associate (E3) /

PTR Regional Hub Regulatory Manager (E4)1

Department: Pharma Technical Regulatory (PTR)

Job Family / Category: PTR Regional Hubs

 

Purpose

 

This position will be responsible for execution and management of regional life-cycle submissions for all Roche products as well as new product registrations by focusing on local needs of Affiliate Drug Regulatory Affairs (DRA) teams to ensure right first-time submissions to Health Authorities.

 

Responsibilities:

 

* The incumbent will be the primary technical regulatory (CMC) point of contact for the Affiliate DRAs and as such he/she will work closely with them and the regional Supply Chain teams as well as with the PTR product managers and the PTR network.

* In coordination with global PTR Technical Regulatory Leaders (TRL), execute regulatory strategy for lifecycle submissions in Asia Pacific markets associated to management of CMC changes originating at manufacturing sites or affiliates toward maximizing efficiency, quality and rate of submission approvals by Health Authorities.

* Coordinate strategic planning with Regional Supply Chain and Affiliates DRA for change management alignment and early visibility/communication/planning of changes impacting markets in the region.

* Assemble lifecycle submissions for markets under responsibility to guarantee right first time submissions and coordinate/manage with affiliates for timely and effective submission of changes to the Health Authorities.

* Act as subject matter expert in regulatory requirements for post approval submissions and maintain the regulatory intelligence repository for regional markets under responsibility.

* Ensure timely update of the CMC change management electronic systems with the regulatory information submitted/approved externally by a Health Authority or internally by the appropriate functional area.

* Upon request, support Affiliate DRA with interactions with regulatory authorities to facilitate the prompt review and approval of submissions (CMC content Subject Matter Expert).

* Manage timely responses to Health Authority questions resulting from lifecycle submissions in regional markets under responsibility.

* Manage tracking of commitments with a Health Authority as result of license/dossier approval and ensure commitments due dates are met.

* The candidate may be required to travel to other Roche sites on a periodic basis.

...

PTR APAC Regional Hub Associate Director

 

Purpose

 

This position will lead a PTR team regionally located in Singapore responsible for Asia Pacific regional management of life-cycle submissions for all Roche products as well as new product registrations by focusing on local needs of Affiliate Drug Regulatory Affairs (DRA) teams to ensure right first-time submissions to Health Authorities.

 

Responsibilities:

 

* Lead team of professionals responsible for regional/local management of lifecycle submissions in Asia Pacific markets, including: market applications (NDA/BLA), post-approval submissions/variations, renewals and annual reports, for pharmaceutical small molecules and biological products.

* In coordination with global PTR Technical Regulatory Leaders, lead submission strategy for execution of lifecycle submissions in Asia Pacific markets associated to management of CMC changes originating at manufacturing sites or affiliates toward maximizing efficiency, quality and rate of submission approvals by Health Authorities.

* Liaise with Regional Supply Chain management team and Affiliates DRA for strategic planning and influencing change management alignment and early visibility/communication/ planning of changes impacting markets in the region.

* Lead assembly of lifecycle submissions for markets under responsibility to guarantee right first time submissions and coordinate with affiliates for timely and effective submission of changes to the Health Authorities.

* Act as subject matter expert in regulatory requirements for post approval submissions and assure maintenance of regulatory intelligence repository for regional markets under responsibility.

* Ensure that the CMC change management electronic systems are timely updated and maintained in alignment with the regulatory information submitted/approved externally by a Health Authority or internally by the appropriate functional area.

* In coordination with Affiliates DRA, act as direct liaison with regulatory authorities to facilitate the prompt review and approval of submissions (CMC content Subject Matter Expert).

Manage timely responses to Health Authority questions resulting from lifecycle submissions in regional markets under responsibility.

* Manage tracking of commitments with a Health Authority as result of license/dossier approval and ensure commitments due dates are met.

* Manage work activities for team members supporting the Asia Pacific region.

* The candidate may be required to travel to other Roche sites on a periodic basis.

 

...

PTR Regional Hub Sr. Regulatory Associate (E3) /

PTR Regional Hub Regulatory Manager (E4)1

 

Department:                       Pharma Technical Regulatory (PTR)

Job Family / Category:      PTR Regional Hubs

 

Purpose

 

This position will be responsible for execution and management of regional life-cycle submissions for all Roche products as well as new product registrations by focusing on local needs of Affiliate Drug Regulatory Affairs (DRA) teams to ensure right first-time submissions to Health Authorities.

 

Responsibilities:

 

* The incumbent will be the primary technical regulatory (CMC) point of contact for the Affiliate DRAs and as such he/she will work closely with them and the regional Supply Chain teams as well as with the PTR product managers and the PTR network.

* In coordination with global PTR Technical Regulatory Leaders (TRL), execute regulatory strategy for lifecycle submissions in Asia Pacific markets associated to management of CMC changes originating at manufacturing sites or affiliates toward maximizing efficiency, quality and rate of submission approvals by Health Authorities.

* Coordinate strategic planning with Regional Supply Chain and Affiliates DRA for change management alignment and early visibility/communication/planning of changes impacting markets in the region.

* Assemble lifecycle submissions for markets under responsibility to guarantee right first time submissions and coordinate/manage with affiliates for timely and effective submission of changes to the Health Authorities.

* Act as subject matter expert in regulatory requirements for post approval submissions and maintain the regulatory intelligence repository for regional markets under responsibility.

* Ensure timely update of the CMC change management electronic systems with the regulatory information submitted/approved externally by a Health Authority or internally by the appropriate functional area.

* Upon request, support Affiliate DRA with interactions with regulatory authorities to facilitate the prompt review and approval of submissions (CMC content Subject Matter Expert).

* Manage timely responses to Health Authority questions resulting from lifecycle submissions in regional markets under responsibility.

* Manage tracking of commitments with a Health Authority as result of license/dossier approval and ensure commitments due dates are met.

* The candidate may be required to travel to other Roche sites on a periodic basis.

...

Department:                       Pharma Technical Regulatory (PTR)

 

Job Family / Category:      PTR Regional Hubs

 

Position:                             PTR Regional Hub Sr. Regulatory Associate

                                           PTR Regional Hub Regulatory Manager

 

Location:                           Tuas, Singapore

 

Purpose

 

This position will be responsible for execution and management of regional life-cycle submissions for all Roche products as well as new product registrations by focusing on local needs of Affiliate Drug Regulatory Affairs (DRA) teams to ensure right first-time submissions to Health Authorities.

 

Responsibilities:

 

* The incumbent will be the primary technical regulatory (CMC) point of contact for the Affiliate DRAs and as such he/she will work closely with them and the regional Supply Chain teams as well as with the PTR product managers and the PTR network.

* In coordination with global PTR Technical Regulatory Leaders (TRL), execute regulatory strategy for lifecycle submissions in Asia Pacific markets associated to management of CMC changes originating at manufacturing sites or affiliates toward maximizing efficiency, quality and rate of submission approvals by Health Authorities.

* Coordinate strategic planning with Regional Supply Chain and Affiliates DRA for change management alignment and early visibility/communication/planning of changes impacting markets in the region.

* Assemble lifecycle submissions for markets under responsibility to guarantee right first time submissions and coordinate/manage with affiliates for timely and effective submission of changes to the Health Authorities.

* Act as subject matter expert in regulatory requirements for post approval submissions and maintain the regulatory intelligence repository for regional markets under responsibility.

* Ensure timely update of the CMC change management electronic systems with the regulatory information submitted/approved externally by a Health Authority or internally by the appropriate functional area.

* Upon request, support Affiliate DRA with interactions with regulatory authorities to facilitate the prompt review and approval of submissions (CMC content Subject Matter Expert).

* Manage timely responses to Health Authority questions resulting from lifecycle submissions in regional markets under responsibility.

* Manage tracking of commitments with a Health Authority as result of license/dossier approval and ensure commitments due dates are met.

* The candidate may be required to travel to other Roche sites on a periodic basis.

...

IT Quality is a trusted partner for customers to ensure and improve the overall quality of IT systems throughout their lifecycle with a focus on compliance with regulatory, legal and finance requirements.  We are looking for a customer-focused, highly collaborative individual responsible hosting and supporting audits and inspections and ensuring audit corrective actions are tracked and closed in a timely manner.   The position is responsible for effective planning and management of audits and inspections with business quality and audit groups.  Further responsibilities include:

• Leads, hosts,  and supports audit management for IT for various sites for internal and external audits and inspections and provides regular updates to stakeholders and informs management of potential issues
• Prepares IT teams for audits and inspections using his/her knowledge of IT controls and auditing practices and provides training to IT staff in support of key IT controls and audit readiness procedures
• Manages the audit program in compliance with quality requirements for ICFR, FDA regulations, legal and security policies, IT controls.
• Facilitates execution of corrective actions ensuring that weaknesses identified in the IT management system are identified, recorded, prioritized and addressed appropriately.  
•   Conducts vendoraudits and internal system assessments for Informatics
• Serves as custodian for legacy IT controls, IT Narratives, Master Audit Schedule to support audit and compliance processes.
• Develops, monitors and improves processes and tools to improve the compliance of  IT systems and to facilitate joint business decision making from a cross-functional and global perspective
• Develops strong working relationships with and partners effectively with IT delivery teams and with global Business Quality, Corporate Audit, Finance and security organizations
• Maintains industry knowledge and skills in the compliance, audit, and risk management and  applies them to improve internal processes and practices

...

 The QC Pharmaceutical Specialist will be a member of the Method Transfer, External QC, and Method Monitoring group, which is part of ROCHE/GENENTECH’s Global Method Management and Technology (Global MMTech), the department responsible for the life cycle management of all commercial methods and control systems and innovation within Commercial Biologics Quality.
Method Transfer, External QC, and Method Monitoring is responsible for all aspects of assay transfer, QC support of CMOs and partners, and method monitoring activities across ROCHE/GENENTECH’s entire commercial network, including CMOs and partners. The successful candidate will provide QC oversight of Contract Manufacturing Organizations (CMOs) who manufacture and test commercial ROCHE products.

Job Responsibilities:
The successful candidate will be responsible for managing all QC aspects at our CMOs on a global basis as the single point of contact representing ROCHE/GENENTECH. The scope of this role includes all US based CMOs that manufacture and test Commercial Small Molecule Pharmaceutical Products. Responsibilities include, but are not limited to, the following key aspects: Qualify CMO for QC testing and data review; ensure appropriate adherence to cGMP requirements at CMO; work with appropriate subject matter experts to provide support to CMO in QC related investigations and analytical method issues; participate in laboratory audits and inspections; participate on Quality Review Boards as needed; manage change control for all CMO analytical methods and laboratory impacting activities; review and approve documents; manage critical reagents/reference standard supplies for CMOs; support preparation of Annual Product Quality Reports.

...

Job Duties/Responsibilities

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

...

Senior Finance Manager - Commercial Finance

The Senior Finance Manager is responsible for providing financial management and value-based business decision support to the Nutropin and Pulmozyme Franchises within the Genentech Commercial organization. This position reports to the Director, IMPACT Decision Support within Commercial Finance, and could be a Finance Manager depending on the candidate’s background and experience.

 

RESPONSIBILITIES

• Act as a business partner who adds value by understanding the needs of the business and proactively identifying opportunities that drive financial results
• Act as an internal consultant by providing financial consultation and guidance to business partners as needed; support business in understanding state of finances and tactical/corrective actions required to achieve objectives
• Partner with brand teams on business development opportunities to provide financial/value perspective.  Build Xcel-based financial models to influence and drive negotiations and deal participation
• Conduct forecasting and analysis of marketing and sales expenses in support of business planning deliverables (10-year Business Plan, 3-year Brand Plan, 1-year Tactical Plan/Budget, quarterly corporate forecast submissions)
• Conduct month-end close for brands – review posting of appropriate journal entries by Finance Analysts and provide explanations on variance/performance drivers to Nutropin and Pulmozyme Brand Teams
• Monitor compliance with financial policies and recommend/take actions as needed
• Prepare and present financial reports requiring translation of complex quantitative data to multiple levels of business partners
• Conduct financial data mining and value-based business analysis to provide insights and guidance in support of business decisions and objectives
• Build and maintain effective partnerships with Product Managers, Marketing Directors, Franchise VPs as appropriate, and others within Commercial Finance
• Support strategic projects for IMPACT and Commercial Finance as needed to inform business decisions
• Mentor and develop Financial Analysts (indirect report)
• Participate in process improvement initiatives within Commercial Finance

COMPETENCIES

• Demonstrates theoretical/financial and cross-functional understanding in financial problem solving; works effectively on issues where analysis of situations or data requires in-depth evaluations of variable factors with intra-Commercial impact; demonstrates judgment in selecting methods and techniques to solve routine financial and tactical problems of moderate scope and complexity; contributes sound ideas in developing recommendations for more complex problems; anticipates problems and offers solutions
• Solid experience and facility with distilling business development and M&A situations into key drivers that can be modeled in Xcel
• Interacts and collaborates effectively within workgroup and area of expertise; participates effectively on cross-functional teams; offers views and actively solicits ideas from others in seeking sound business solutions; encourages others in fostering effective teamwork; demonstrates very strong customer service orientation
• Gets point across clearly, with straightforward language, both verbally and in writing; considers the needs and interests of others and incorporates information relevant to them in communications; readily grasps the main points in communications from others
• Plans, prioritizes and reports status on tasks; operates independently with limited supervision, holding self accountable to fulfill assigned tasks and achieve results within timelines; establishes own work priorities and timelines within scope of authority; responds to requests with appropriate urgency and an organized approach; may provide guidance and coordinate work activities of others
• Monitors process effectiveness and efficiency against goals and objectives, taking corrective action as necessary; identifies, implements, and supports complex process improvements
• Understands strategic priorities developed by upper management; recognizes relationship between workplace results and what caused them; able to shift between tactical and strategic perspectives based on audience and project needs

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The senior DBA manager leads and manages a staff of Database Administrator (DBA) professionals for Genentech database environment that includes Oracle and SQL Server. The individual will work with other global IT team leaders to translate the organization's IT strategy into specific database roadmaps and deliverables, measures the effectiveness of the delivery model, and track progress against plan and operational Service Level Agreements (SLA). The individual will provide management and implementation of strategic initiatives for the enterprise databases services in the charge toward efficiency and optimization. In addition, the individual is responsible for developing processes and procedures for overall IT Operations, upgrading and maintaining IT processes,production controls, capacity planning, and system backups and recovery. 

Key Strategic Objectives

* Lead the organization through organizational change, technology transformation, and sustained growth while exhibiting excellent judgment on how to prioritize between operational excellence and financial prudence

* Drive successful creation of a strong team dynamic in a collaborated and risk-taking

culture. Translate the organization's strategy into tactical execution plans replete with key performance measures and monitor the results on regular basis

* Improve Genentech's return on invested capital by having a systematic capacity planning process to maximize the utilization of assets and increase the velocity of infrastructure investment in virtualization and cloud computing.

* Build and develop future leaders of the organizations while advancing Genentech's image as one of the best places to work in America.

Responsibilities:

• The right candidate for this position is well organized, and an exceptional communicator with his/her team, peers, executive management, and the company. 
• This person must be able to lead and manage change. The individual will live by metrics, staying ahead of the tactical while also deeply understanding the needs of various business teams to appropriately plan for growth and change.
• Demonstrated ability to lead and energize multidisciplinary teams with gifted communication and interpersonal skills. 
• Demonstrated analytical, problem-solving and conceptual skills. 
• Ability to analyze project needs and determine resources needed to meet objectives. 
• Demonstrated negotiation skills with vendors or management and ability to influence management regarding matters of significance to the organization. 
• The successful candidate must be able to establish credibility very quickly in organization with shifting priorities. 
• The individual must be a strong leader who can prioritize well, communicate clearly and compellingly and who understands how to drive a high level of focus and excellence with a strong, talented, opinionated team.
• The individual will have a technical aptitude particularly in the database domain and be credible as leader in a technical organization. 
• The individual will be able to articulate with full clarity the aspiration of his teams, and achieve results through influence and leadership rather than direct authority...

The Forecasting Manager/Senior Manager will support Brand Teams and
Commercial Management decision-making by delivering revenue forecasts
on a regular basis throughout the year as well as in response to ad-
hoc customer requests. This individual will play an integral role
with responsibility for ensuring that all forecasts are based on
reliable information and rigorous analyses, including uncertainty
analyses, and that short-term and long-term forecasts are aligned.
He/she will partner with different functional groups (Marketing,
Customer Operations, Finance, Supply Chain, and other groups within
Market Analysis & Strategy) to deliver analyses that enable a
thorough understanding of brand performance and expectations. He/she
will work with multiple Excel-based models as well as other
quantitative and qualitative resources to perform scenario analyses.
In addition, he/she is expected to present findings to key
stakeholders, provide recommendations, and implement approved
recommendations.

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