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.

...

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.

...

POSITION:

Finance Manager (G&A Finance)

Reporting to the Associate Director, G&A Finance, the Finance Manager will provide strategic and traditional finance support to the Workplace Effectiveness, EHS and Security groups within the Site Services organization.  Workplace Effectiveness includes Genentech Real Estate, Workplace Planning, and SSF Site Engineering.  The role will interface with key stakeholders within Site Services, Finance, and other areas within the Genentech/Roche organization.

JOB DESCRIPTION:

Manage and coordinate planning deliverables to meet corporate objectives and deadlines. This includes annual budget, quarterly forecasts, the 5 Year & 10 Year Business Plans 

• 
  
• Manage the month/quarter end close processes including journal entries, accruals, account reconciliations, reporting, detailed variance analysis of results
• Member of the Workplace Effectiveness Forum - provide financial and non-financial support to assist in strategic decision making
• Build and maintain effective and collaborative business partnership between the Finance team and Workplace Effectiveness stakeholders
• Proactively identify, design, and implement enhancements to existing processes
• Propose and implement innovative solutions to complex business issues through ad hoc analyses
• Effectively communicate financial information with all levels of the organization, including senior management

...

The Finance Manager will be part of a team that provides financial planning systems and reporting development, enhancement and maintenance expertise for Roche Canada finance groups and Genentech Commercial finance groups.  The position is located in the United States Eastern time zone and will report to the Finance Manager of Commercial Financial Planning Systems who is based in South San Francisco, CA.  The Finance Manager will be expected to travel to Toronto, Ontario and South San Francisco occasionally – six to eight times per year

The working environment is fast-paced with an ever-changing set of priorities.  The role will interact extensively with the following finance organizations:

• Roche Canada Commercial Affiliate finance
• Roche Canada Informatics finance
• Roche Canada Product Development finance
• Genentech Commercial Affiliate finance
• Genentech Affiliate FP&A finance (embedded in Commercial Affiliate finance)
• Other Financial Planning Systems teams, and Pharma and Global Informatics 

MAJOR RESPONSIBLITIES  
• Design, develop, enhance and maintain financial performance management applications (almost exclusively IBM Cognos TM1)
• Design, develop, enhance and maintain web-based reporting solutions (almost exclusively IBM Cognos BI Report Studio and Cognos Office Connection) whose data is sourced from the performance management applications
• Support business planning processes identified below:
o Current year forecast
o Next year budget
o Long range (strategic) business plan
o Accounting month end close
• Process improvement initiatives

MAJOR SKILLS / TRAITS
• Strong communication and presentation skills and demonstrated success in building partnerships across organizational boundaries
• Commitment to customer service with a strong sense of ownership for projects and results is a must
• Strong work ethic, independent, flexible and demonstrated ability to work autonomously
• Independent self-starter and proactive leader; seeks to continually improve business processes
• Solid understanding of finance and accounting flows as well transaction flows in ERP systems
• Proficient understanding with:
o IBM Cognos TM1, a Performance Management OLAP technologies:
o Master data, transactional data, and data flows within information systems
o IBM Cognos Report Studio, a web-based reporting solution
• Ability to multi-task and meet deadlines in a highly demanding and fast paced environment

...

Finance Manager, FP&A

Reporting to the Associate Director, FP&A, the Finance Manager will support the corporate planning processes, including forecast, budget, and long-term planning.  This position will be responsible for both delivering forecasts/budgets to local management as well as submission of the plans to Basel.  This role will require significant interface with other finance and planning groups across the organization.

Job Description:

• Manage and coordinate planning exercises to meet corporate reporting schedules and goals
• Review and analyze planning data and develop presentations for senior management review
• Act as the primary liaison with Basel (Global HQ) and functional finance teams (at South San Francisco) for all planning-related issues
• Lead ad hoc analyses as assigned to support senior management strategy discussions and decisions
• Proactively identify, design, and implement enhancements to existing planning processes and systems 

...

Lifecycle management of Enterprise Directory systems (Microsoft, SUN, Kerberos, Radiant Logic VD)

Lifecycle management of Federation systems (Ping Federate, Siteminder, Microsoft ADFS)

Work on projects related with these components

Create and manage Single Sign On integrations (Ping, Siteminder, JBoss)

Support other Identity and Access Management teams: Identity Systems, Access management, on/off boarding (worldwide presence)

Participate in security hardening drills, audits, proof of concept

Work on user requests, incidents and problems

 

• 2-7 years of successful technical experience supporting Enterprise Directories, Single Sign-On solutions and Federation Services for internal and hosted/SaaS applications
• Proven technical operational skills, and capability to create and validate well-structured answers and solutions in area of responsibility
• Proven interpersonal skills to interact effectively with Informatics staff in multiple countries and varying cultures
• Good understanding of Identity and Access Management systems, operations and related processes with focus on Active Directory, Federation Services, Kerberos, SUN LDAP and Password Management solutions.
• Provides 2nd level support related to Enterprise Directories, Single Sign-On and Federation Services.
• Documents the corresponding processes and components/solutions
•  

Problem Management

• Follows ITSM processes for 1st level problem management
• Act 
• s a source for establishing and recommending that multiple incidents should be declared as a problem to the relevant service providers. Tracks problems until resolved.
• Ensures accurate and complete problem tickets logged in ITSM tool adhering to Roche ITSM processes
• Ensures the Knowledge Management System (KMS) is updated with workarounds, known errors and solutions

 

Incident Management

• Follows ITSM processes for handling incidents
• Monitors ticket queues for the relevant workgroup action within agreed targets
• Ensures accurate and complete incident and change tickets are logged in ITSM tool and adhere to Roche ITSM processes
• Manages, meets and maintains service levels where appropriate
• Continuously improves own skills and knowledge base of services provided by Roche

...

• Provide project management and administrative support for project team working to determine feasibility of Leadership Energy and Environmental Design (LEED) Certification.

• Work with LEED consultant to set clear performance expectations for team members to ensure successful completion of project objectives.

• Communicates and coordinates among all stakeholders within and outside the GNE organization including but not limited to client groups, service providers, suppliers, procurement to collect LEED Certification data.

• Manage data collected to enable reporting required to generate reports for feasibility or certification processes.

• Organize and develop material for presentation to Genentech and members of the U. S. Green Building Council (USGBC) for LEED Certification.

• Demonstrated success in leadership and organizational management in a technical, team orientated environment.

• Demonstrated ability to anticipate, prioritize, and adapt to changing workload situations.

• Excellent interpersonal and communication skills.

...

Responsible for implementing and maintaining the validated state of equipment, IQ,OQ,SIP and cleaning validation programs. 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.

• Manage and track the Validation program and assigned validation projects and ensure target
• timelines are met and/or issues are communicated / escalated effectively and consistently.
• Generate, review, approve and maintain Validation Project Plans and Summary Reports and other validation lifecycle documents.
• Generate, review and approve a variety of Validation protocols (IQs, OQs, IOQs, PQs, SIP, CV) for equipment.
• 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 equipment/systems temperature mapping and cleaning validation program.
• Proven ability to make suggestions for improvements as well as ensure programs are operating in a compliant and validated state.
• Present validation packages as required for audits and/or regulatory inspections.
• Perform role of subject matter expert and assess change control and discrepancy events for to validated systems.
• 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.
• 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 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.

...

Position Purpose:

Epidemiologists work under the supervision of a Global Epi TA Head to review, generate and interpret quantitative evidence on disease from observational data sources to strengthen decision-making and minimize risk throughout research and development.

Major Responsibilities and Accountabilities:

• Works independently using effective epidemiologic principles and methods
• Works effectively in project teams
• Responsible for epidemiologic deliverables to project teams

Primary Skills/Features:

• Contributes to the design of safety signal investigations
• Researches and provides background adverse event rates in order to contextualize observed adverse events
• Designs observational studies and writes protocols under supervision
• Serves as an epidemiologist on observational study teams
• Provides guidance for ensuring data quality during study conduct
• Experienced with principles and techniques of data analysis and interpretation
• Contributes to study reports, analysis plans, and publications for observational studies
• Represents epidemiology and works independently and effectively on cross-functional teams
• Management (projects and/or personnel)
• Manages epidemiology projects for teams
• Identifies and manages contracts for vendors and outsourced projects
• May mentor associate epidemiologists, contract epidemiologists, & interns

Communication:

• Develops agendas, leads meetings, and provides periodic updates to project teams and senior managers
• Seeks appropriate communication channels
• Effectively articulates how epidemiology supports project goals
• May interact with the FDA and other agencies
• Selects appropriate consultants for contract work
• Is highly professional & scientifically rigorous
• Builds an understanding of roles and responsibilities of other functional areas
• Educates teams on epidemiologic methods and principles

...

  Responsibilities: This position is for a Validation Engineer  reporting to a Manager of Technology Validation in the South San Francisco Production Technology Department.  The candidate will be responsible for Validation scope supporting the South San Francisco manufacturing plants.  This includes drafting and execution of validation protocols, authoring validation and technical reports and development of project plans.  In addition, the candidate will support technical assessments for quality impact and participate on quality investigation teams.  The candidate will also monitor maintenance of the validated state of basic and some complex equipment and processes.  This includes monitoring operations and resolving moderate validation issues.  The candidate will support introduction of clinical products into manufacturing by participating on campaign/product planning teams and delivering the appropriate validation activities consistent with project timelines.  The candidate may lead cross functional teams or projects.  The candidate will be expected to work effectively in teams, to influence others to generate support for assigned activities or projects and to justify goals to department colleagues.  They will also act as a mentor for those with similar or less validation expertise. ...

 

The position:

The Senior Engineer in the Process and Project Engineering Group in the South San Francisco Production Technology Department will be responsible for Process Engineering (Process Equipment Design) and Project Management of Drug Product projects for the SSF Production Business Unit.   The support areas include commercial and clinical filling lines, inspection and clinical packaging.  The candidate must also provide mentorship and direction to partner MSAT groups on execution of process engineering design and project management.  In addition, the candidate will provide Process Engineering services such as approval of P&ID changes, IQ, Material of Construction forms, Engineering Design Review and Engineering Change Records.  The candidate will be responsible for development of business systems to support efficiency and sustainability.  The candidate will also help provide strategic direction to transformation of the Drug Product manufacturing capabilities.

 

...

 

• Lead and/or participate in tech transfers of purification processes across Roche/Genentech’s drug substance manufacturing facilities and to external contract manufacturing facilities.  Requires close collaboration with cross-functional team to implement, validate, and license Drug Substance processes at receiving sites.
• Responsible for providing on-going technical support for Drug Substance production at contract and partner sites. Includes monitoring process performance, resolving manufacturing deviations, participating in quality investigations, and providing technical approval of document and automation recipe changes to support continuous process improvement.
• Lead and/or participate in global initiatives and cross-functional teams in the areas of downstream processing.
• Work collaboratively with site Manufacturing Science and Technology (MSAT) groups to develop and communicate best practices for process design and operations to ensure consistency and compliance across the biologics manufacturing network.
• Represent MSAT Network on corporate initiatives led by partner groups such as Quality, Regulatory, Manufacturing Operations, Pharma Technical Development, etc.
• Provide technical leadership for topics including support for proposed manufacturing process changes, process validation, discrepancy and investigation evaluations, change control, and regulatory submissions. Some lab work may be required in order to resolve investigations and/or demonstrate proof-of-concept for proposed process changes.
• Responsible for authoring and reviewing technical reports, manufacturing instructions, process validation documents, and portions of regulatory submissions to support licensing processes at new manufacturing sites.
• Travel within the Roche network and to contract manufacturing sites will be required.

 

 

 

...

Summary:

This is an E2/E3 Automation Engineering position mainly intended to provide support for biopharmaceutical manufacturing projects and operations as part of the Vacaville Technology Science and Engineering Automation Group. Area of focus will primarily be the manufacturing production Distribution Control Systems (DCS) system. Candidate must be a self-starter who can independently drive projects and day-to-day work tasks to completion according to a defined budget and schedule. The candidate must be able to work well with others in an informal results oriented environment.

Responsibilities:

• Software/hardware design, development, test, implementation and support for the manufacturing Distributed Control System (Siemens APACS - Wonderware Archestra DCS).

• Troubleshooting of automation issues impacting the manufacturing process, processing equipment and/or the DCS.  

• Providing 24/7  on-call support on a rotating basis.

• Providing technical assessments and evaluations for discrepancies that occur during manufacturing operations

• Providing technical input for investigation and developing and implementing automation related corrective action plans.

• Developing and revising  automation design documents

• Preparation of automation work plans and automation related change records

• cGMP compliant execution of off-line and on-line coding and testing.

• Supporting and leading Automation projects including detailed design, design review, implementation, testing/debug, and troubleshooting.

• Collaborating with the Manufacturing, BSI, Quality, Facilities, and Technology departments to implement continuous improvement changes as well as capital projects.

• Providing clear written and verbal communication across functional departments at various levels to drive efficient issue resolution and change implementation.

...

Under the direction of the MSAT Technical Services Manager, the Engineer I, Validation will be accountable for validation activities such as Performance Qualification (PQ) / Cleaning Validation (CV) / Process Validation (PV) and Revalidation (RV) activities. Candidate will be able to collaborate with both plant and corporate organizations seamlessly, will be constantly in search of the most creative and innovative solutions to maintaining the highest levels of productivity and will able to provide the leadership necessary to maintain a high performance culture. Responsibilities: Develop, execute, and manage the detailed project plans and timelines for the execution of PQ/CV/PV/RV activities. Plan and execute PQ/CV/PV/RV activities. Prepare validation & change control, documentation, including protocols, summary reports, etc., for validation activities. Act as project manager for validation teams ensuring new systems are implemented within predetermined timelines and financial forecasts. Provide input into investigations with potential validation impact. Present and provide rationale for the validation program during periodic audits and regulatory inspections. Procure and manage contractor support for outsourced validation assignments. Coordinate the collection, testing and analysis of samples and reporting of results required per validation protocol. Support the change management system for validated equipment, utilities and facilities. Prepare, review and approve relevant sections of regulatory submissions. Serve as a representative on cross-functional and multi-site teams. Lead and facilitate the development of formulation, filling, and packaging, area SOP’s and manufacturing documents as appropriate. Foster an environment that encourages continuous learning. Maintain expertise as necessary to stay abreast of technical and industry advancements. Manage the development and implementation of novel approaches to solving complex technical problems while maintaining required levels of safety, quality (including regulatory compliance), and production....

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.

...

Responsibilities:

This position will focus on supporting our PD Engineering Data Analysis Key Focus Area. The primary responsibilities include developing, implementing and supporting novel data analysis tools. The data analysis tools include, among others, multivariate analysis, applied statistics, modeling, optimization and other applied mathematical fields. The data analysis tools will aim at increasing the efficiency in different development groups, pilot plant and large-scale manufacturing sites. A significant part of the time will include analyzing process data from different organizational groups and transforming them from data to knowledge. The new hire will interact with vendors and customers, perform experiments in lab and pilot plant scale and identify new opportunities to bring more efficiencies to our customers in the field of data analysis. Efficient oral and written communications as well as good collaboration skills are expected.

...

Title: Engineer I
Job Category: Manufacturing
Department: Process and Project Engineering
Level: E2/E3
 

Responsibilities:

This position is for a Process Engineer reporting to a Manager in the Process and Project Engineering Group in the South San Francisco Production Technology Department.  The candidate will be responsible for Process Engineering and Project Management of both Drug Substance and Drug Product projects for the SSF Production Business Unit.  Primary responsibilities include supporting design, construction, startup, and upgrades to manufacturing equipment.  The candidate will provide mentorship and direction to partner MSAT groups on execution of process engineering design and project management.  The candidate will also provide Process Engineering services such as approval of P&ID changes, IQ, Material of Construction forms and ECOs on a rotating basis.  In addition, the candidate may support development of business process improvements to support efficiency.  The candidate will be hired as an Engineer I or Engineer II based on level of experience.

 

...

Lead the development of pharmaceutical manufacturing processes or technologies on bench & pilot scale and implementation on a manufacturing scale. Collaborate across multiple functional areas such as formulation development, manufacturing and validation. Utilize advanced engineering principles, concepts and techniques to solve technical problems in the following areas of focus: storage / handling of protein bulks, freezing, thawing, mixing, sterile filtration, filling, pre-filled syringes, microencapsulation, lyophilization, vial inspection and/or terminal sterilization by radiation, vaporized hydrogen peroxide, or other gases. Support or lead technical projects and on-going manufacturing operations including technical transfers between sites and performing trouble shooting activities. Managerial responsibilities commensurate with experience.

...