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

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

Primary Responsibilities:

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

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

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

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

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

Main Purpose of the Position:   

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

Job Duties/Responsibilities:

·               Follow company policies and procedures.

·               Maintain a state of inspection readiness.

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

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

·               Independently manage competing priorities with limited instruction.

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

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

·               Provide assistance to customers in support of departmental functions.

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

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

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

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

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

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

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

Technical Duties/Responsibilities:

·               Evaluate and close complex, non-investigational discrepancies.       

·               Initiate discrepancy investigations as required.       

·               Draft and route discrepancy summaries to Discrepancy Management.         

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

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

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

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

Strong communication, presentation and organizational skills are necessary.

Intern Project Deliverables

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

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

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

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

-- Ensures nimble decision making

-- Enhances operational practice sharing and process governance

-- Facilitates bulk network optimization and workforce planning

-- Facilitates bulk capacity utilization and cost of clinical manufacturing

-- Creates a clear charter and performance measures

Responsibilities:

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

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

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

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

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

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

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

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

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

• Job Family & Role-specific Responsibilities:  

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

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

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

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

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

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

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

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.

Job Title: Senior Specialist (E4/5)

Job Responsibilities:

·         Key contributor for developing consistent strategies for stability studies performed at different sites, CMOs and partners

·         Manage and monitor milestones and detail timelines for assigned commercial products to ensure the achievement of corporate goals and objectives while providing timely and transparent communication to the PMT subteams and other cross-functional teams.

·         Provide scientific rational for stability study design and propose changes for the Genentech Quality organization

·         Provide scientific and technical leadership in Inspection/ Audit situations, thinking critically and acting creatively while providing information quickly and accurately

·         Author and  provide scientific as well as technical representation of Stability in all stability relevant sections for Submissions, Regulatory Agency responses, APRs and ARs

·         Work closely with other Senior Specialists and senior management to develop strategy for long range operational and resource planning   

·         Serve as a subject matter expert (SME) for stability questions related to assigned commercial products

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.

Provide automation support for biopharmaceutical manufacturing operations as part of the Vacaville Technology Upstream Frontline Group. Support will primarily be focused on the manufacturing production Distribution Control Systems (DCS) system involving cell culture manufacturing including fermentation, media prep, and harvest operations. Candidate must be a self-starter who can independently drive day-to-day work tasks to completion according to schedule and must be able to work well with others as a team member in an informal results oriented environment.

Responsibilities: Automation design and support to the manufacturing Distributed Control System (Siemens APACS, APS, Archestra) as well as providing support to implement automation changes. This person is expected to perform troubleshooting of process, equipment, and system malfunctions or failures involving the DCS system, including after-hours on-call support on a rotational basis. Ability to initiate corrective or preventative actions to ensure continued compliant operation including emergency change records as needed. Provide technical assessments and evaluations for discrepancies that occur during manufacturing operations, as well as provide technical input for investigation and/or developing and implementing corrective action plans. A key part of this person’s role will be to redline automation functional specifications for automation lead review/approval, troubleshoot the DCS system and software, prepare automation software change work plans and perform off-line and on-line coding and testing. This person will support automation projects with activities such as detailed design, design review, implementation, testing/debug, and troubleshooting. This position includes working with the Manufacturing, BSI, Quality, Facilities, and Technology departments to implement software changes. This person will be expected to clearly communicate across functional departments at various levels to drive efficient issue resolution and change implementation. The position may involve the cross-training in another discipline within Upstream Frontline, such as Validation, Process Engineering, or Manufacturing Sciences where business needs allow.

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.

This position may be filled at an Associate Field Reimbursement Manager or Field Reimbursement Manager level.
 
The Territory for this position will cover New York City and New Jersey North. 

Candidate can live within any of  these territories, but would prefer New York City.

 
The Retinal Field Reimbursement Manager (RFRM) helps to minimize reimbursement barriers for patients and providers and, therefore, helps to optimize access to Genentech products in the assigned therapeutic area.  The FRM works closely with internal partners, supporting targeted accounts, and helping resolve reimbursement issues or concerns. They also develop ethical and customer-oriented reimbursement tactics, and proactively communicate payer criteria/terms and practices, as these relate to reimbursement for the assigned GNE products.

• Works with internal partners to review franchise, managed care, and divisional field sales business plans and objectives
• Acts as a subject matter expert on the payer landscape relevant to the assigned Genentech therapeutic area(s)/product(s)
• Acts as a conduit between the Field and Home Office Genentech functions for all public and private payer policies and practices that impact patient access to Genentech products
• Assists Coverage & Reimbursement with individual case management needs
• Develops ethical and customer-oriented reimbursement tactics
• Trouble-shoots field account reimbursement issues, needs, concerns, or challenges
• Spends majority of time visiting customer accounts in the field
• Proactively communicates and explains Genentech-specific reimbursement programs, policies, procedures and resources
• Works with relevant state, institutional or other societies
• Complies with all laws, regulations and policies that govern the conduct of GNE activities
• Business travel, by air or car, is regularly required
• In addition to passing Genentechs background screening, the employee must submit to and pass additional background screening as required by some institutions and health facility sales accounts (additional screening requests may include but are not limited to background checks, immunization, TB, HIV, hepatitis, and drug screening)

"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."

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

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

Job Responsibilities:

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