Requirements:

• Provide statistical expertise to multiple nonclinical areas, including projects in research, preclinical studies, assay development, bioprocess development, quality control, and manufacturing.
• Propose experimental design and analysis strategies, perform statistical analyses, and collaborate with investigators to ensure the statistical integrity of nonclinical reports.
• Support regulatory submissions and investigations.
• Build strategic partnerships with collaborators and promote statistical thinking in decision making in nonclinical areas of drug development.
• Provide advice and training on the use of statistical methods and software packages to nonclinical investigators within the company.
• Develop and deliver statistics courses to nonclinical audiences
  Collaborate with scientists in support of external publications.
• Keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review, conference attendance, and professional activities.

...

The QA Product Technical Manager is the key point of contact for all issues affecting the disposition of their assigned product(s). This individual will be responsible for interacting with multiple departments within Roche to assure that all lot disposition issues are identified and resolved within standard lead times.
• 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.
• Support routine operations and allocate assigned resources.
• Manage competing priorities.
• Serve as the Quality representative on cross-functional and multi-site teams.
• Identify, design, and implement process and system improvements.
• Lead and participate in the design and implementation of department and cross-functional initiatives.
• Apply advanced theory, technical principles, and expert judgment to address a broad range of difficult problems.
• Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
• Serve as a technical subject matter expert (SME) in support of department functions.
• Train personnel and internal customers on relevant business processes.
• 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:
• Oversight of the activities associated with dispositioning of assigned production lots within established standard lead times.
• Management of lot disposition activities to ensure that products are dispositioned in accordance with regulatory requirements, cGMPs and Genentech policies and procedures, within established standard lead time.
• Interfacing with appropriate departments or manufacturing plants to ensure that lot disposition items are completed.
• Notification to Senior Management for all known delays in meeting established standard lead times or any potential significant quality issues.
• Interfacing with QA Lot Disposition Supervisors and Final Reviewers to ensure that final review activities are completed. Lead and provide guidance to Final Reviewers as required.
• Perform a review of investigations for potential cumulative effect to a batch history record.
• Perform a review of QC out of trend results for cumulative effect.
• Provide assistance to CMC teams by addressing lot disposition issues as they arise.
• Support regulatory inspections as needed.
• Assess batch history records as part of investigations into product complaints.
• Revise and approve applicable lot disposition documents as needed.

...

As a Principal Staffing Consultant, you will play a lead role in managing the recruiting and hiring programs for our Product Development Staffing 

Main Deliverables:

1. Play a lead recruiting role for approximately 100 positions annually, with an average requisition load of 30-40.
2. Play a lead role in key Product Development  wide staffing initiatives, including those supporting our diversity and hiring best practices programs
3. Partner actively with HR Management to drive internal talent development and succession planning programs
4. Provide original thinking to staffing challenges and execute on ideas for improving patterns of work

Main Accountabilities:

• Deliver Recruiting Results
• Recruit with Insight and Strategy
• Innovate and Expand Possibilities
• Value Collaborations, Communication, and Teamwork
• Execute on Tactics, Tools, and Technology

Full Responsibilities:

• Managing expectations of hiring managers and candidates, identifying and resolving issues
• Drive the employment process and strategies within assigned organization, including developing complex recruiting strategies
• Demonstrate thorough understanding and adherence and enforcement of internal staffing process as well as contribute to the development of staffing process improvements
• Ensures recruiting solutions are consistent with Corporate Staffing goals and objectives
• Partner with Diversity and sourcing counterpart to develop and implement sourcing plans and strategies for your client groups while ensuring that the elements of diversity and organizational fit are included in the recruiting and hiring process
• Proactively manage escalation process related to all requisition activity (internal vs. external challenges)
• Perform executive recruiting, including identifying appropriate Contingency or Retained Search firms, maintaining relationships and partnering to ensure that candidates are interviewed expeditiously
• Develop advertising strategies for specific groups and coordinate advertising activities with recruitment advertising agency
• Build and maintain cross-functional relationships across HR and Staffing
• Utilize, update and maintain applicant tracking system and CRM
• May provide staffing reports and metrics
• Present information on results and metrics at different levels (i.e. to employees, peers and senior level HR and client groups)
• Act as point person for clients in providing staffing reports and metrics
• May Lead and or participate in HR related projects or enterprise wide initiatives.
• Partner with Client Group on internal talent management, including succession planning, talent review and internal candidate movement
• Coach managers in providing feedback to candidates, developing offers, determining competencies, coordinating and training interview team
• Partner with Diversity and HRDs to develop and implement a recruiting strategy that ensures our candidate pipelines are diverse
• Conduct interviews using in depth behavioral and skills assessment techniques
• Educate hiring managers on legal implications in hiring
• Adjust the strategy and align it with the changing needs of the business
• Ensure your compliance with EEOC/OFCCP regulations
• Act as project manager for client focused staffing projects (not just req focused)
• May partner with finance in determining headcount for client group, as well as manage the reconciliation of budgeted headcount vs. actual headcount
• Work with Staffing Manager on recommendations for the EC Group recruitment/relocation budget
• Oversee relocation/recruiting budget for individual client group at the officer level
• Manage multiple relationships, both internally and externally
• Attend professional conferences and networking events
• Responsibility for Conference/Event management related to external recruiting, partner with Corp Staffing in strategic direction of event, and determine ROI for event participation

...

Responsibilities: The successful candidate will participate in the discovery and investigation of novel small molecule drug targets in the therapeutic area of immunology.
Using state of the art techniques and technologies, he/she will investigate various signaling molecules, such as kinases, transcription factors, enzymes, and epigenetic regulators, and assess their potential therapeutic utility. Furthermore, the candidate is expected to independently design, execute, analyze and present experiments to various forums within and beyond the department of discovery immunology, and thus must have excellent communication and interaction skills.
...

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.

...

We are seeking a postdoctoral fellow to work in the laboratory of Dr. Eric Brown. The incumbent will conduct original and significant basic investigations in the area of the pathogenesis of infectious diseases and host response to infection. The expectation is that this work will result in novel and important contributions to understanding of host-pathogen interactions, as evidenced by publication in top tier scientific journals. The laboratory explores both host and pathogen genetics as its approach to understanding the host-pathogen interface and uses a wide variety of genetic, cell biologic, and biochemical methods to investigate these questions. Projects in the Brown lab currently focus on molecular mechanisms and pathologic consequences of Type VII secretion and on regulation of autophagy by ubiquilins....

Job Duties/Responsibilities:

 

• Perform microbiological, biochemical and analytical lot testing of raw materials, E. coli and mammalian cell banks, commercial and clinical fermentation, purification, and final product samples according to GMPs.
• Review data and assess against established acceptance criteria. 
• Evaluate data to identify trends and/or establish limits. 
• Identify gaps in and potential improvements to systems and procedures. 
• Perform equipment qualification and or maintenance. 
• Prepare and maintain standards, controls, stocks, and cultures per established procedures. 
• Assure and apply GMP throughout all operations. 
• Coordinate with customers to support multi-site operational activities. 
• Present analytical procedures and results during internal and external audits and regulatory inspections.
• Participate in and/or lead projects and process improvements. 
• Perform other duties as requested by managers to support Quality activities. 
• Works to meet schedules, timelines and deadlines. 
• Meets scheduled performance of 95% on time.

 

Technical Duties/Responsibilities

 

• Write technical protocols and reports under limited supervision. 
• Identify and propose resolutions for study or project deviations. 
• Provide input to and participate in assay transfer and assay validation.
• Perform technical review of data derived from complex tests. 
• With limited supervision, design and execute quality investigations and CAPA (corrective actions preventive actions) initiatives as needed. 
• Identify, troubleshoot, and propose resolution to technical problems. 
• Identify and propose resolution for discrepancies. 

...

Oral Octreotide Brand Trainer
*Position is based in SSF headquarters

The Brand Trainer supports specific brands in which the responsibilities are a combination of Clinical Trainer and Sales Trainer. Therefore, the Brand Trainer must possess a thorough understanding of the assigned brands product(s) in addition to be able to create training programs for both new hires and advanced sales representatives.

Major Responsibilities:

• Determines the most effective approach to meet product-learning needs of the specific brand business. Applies instructional design principles and adult learning principles to enhance content delivery.
• Establishes goals and learning objectives to design appropriate and effective curriculum by leveraging adult learning principles.
• Researches the clinical issues and leverages resources (internal and external) to support the learning objectives in designing and creating training programs and products.
• Prepares and/or oversees the preparation of clinical training products and programs such as classes, workshops, learning modules, poster books, and other job aids and materials for distribution to CT&D customers and program participants.
• Develops Brand training programs as identified from Sales and Marketing teams focusing on Brand strategies and tactics that will ensure significant impact on increasing business.
• Facilitates Foundation (Phase I), Core (Phase II), and Advanced (Phase III) Training Classes – skilled at group facilitation and group learning exercises.
• Designs and implements metrics to measure clinical training programs and products impact, effectiveness, appropriateness, and utility.
• Filters and distributes educational resources (i.e. clinical papers) to the CT&D customers and other appropriate audiences while remaining contentious of legal and regulatory parameters.
• Collaborates with all CT&D customers and resources: Sales, Marketing, Development, Medical Communications, Clinical, Legal, Regulatory, Library Services, etc. to ensure consistency, avoid redundancy, and that needs are met and leverage internal resources thereby ultimately, enhance training programs.
• Communicates appropriate Commercial Training and Development (CT&D) programs and resources to all customer segments to help support the Commercial Organizations strategic goals.
• Participates as an active member on Commercial and Brand product teams
• Facilitates “Selling Excellence” training programs that will enhance the effectiveness of the field sales organization
• Participates on CT&D internal training initiatives

...

The successful candidate will be involved in late-stage pharmaceutical development ofmonoclonal antibodies, antibody-drug conjugates, and delivery systems for clinical evaluation and commercialization. The responsibilities of this role include formulation development, evaluating product stability and throughout the manufacturing process and performance in diverse delivery systems, as well as biophysical characterization, drafting technical documents and contributions to regulatory filings. Applicants should be comfortable working both independently with minimal supervision and as part of a team to support the development of recombinant protein therapeutics. The successful candidate will also be expected to participate on cross-functional project teams. The position offers opportunities for professional and scientific growth in a dynamic, intellectually stimulating and fast-paced work environment.

...

The Position

• Perform final review, cumulative review and disposition of Genentech manufactured cell banks and clinical drug substance, drug product and final drug product.
• Review and approve procedures, tickets and other clinical QA controlled documentation. 
• Provide clinical trial support such as COA/COC/COT requests.
• Provide support and oversight of manufacturing activities on the floor.
• Manage batch disposition activities to ensure that products are dispositioned in accordance with cGMPs, Regulatory, and Genentech Policies and Procedures and adherence to schedule.  
• Set personal performance goals and collaborate with management to establish organizational objectives.  
• Manage competing priorities to meet department and organizational targets and timelines.
• Serve as the Quality representative on cross-functional and multi-site teams.
• Identify, design, and implement process and system improvements.
• Apply advanced theory, technical principles, and judgment to address a broad range of difficult problems.
• Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance
• 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.
• Interface with appropriate departments to ensure that batch disposition items are complete and timely notification to Management of all known delays and significant Quality issues is provided
• Interact with interdepartmental contacts on discrepancy assessment, resolution, and Quality approval
• Support and present in Internal and Regulatory Inspections.
• Participate in the resolution of Quality issues by fostering effective interdepartmental and cross-functional relationships.
• Participate or lead different internal or cross functional projects relevant to QA lot disposition
• Train new personnel and internal customers on relevant business processes.
• Ability to revise or create work instructions, SOPs and business process instructions.

 

 

 

 

 

 

 

 

...

Rheumatology Brand Trainer

The Brand Trainer supports the Rheumatology Franchise (ACTEMRA and Rituxan) in which the responsibilities are a combination of Clinical Trainer and Sales Trainer. Therefore, the Brand Trainer must possess a thorough understanding of the assigned brands in addition to be able to create training programs for both new hires and advanced sales representatives.
• Determines the most effective approach to meet product learning needs of the specific brand business. Applies instructional design principles and adult learning principles to enhance content delivery.
• Establishes goals and learning objectives to design appropriate and effective curriculum by leveraging adult learning principles.
• Researches the clinical issues and leverages resources (internal and external) to support the learning objectives in designing and creating training programs and products.
• Prepares and/or oversees the preparation of clinical training products and programs such as classes, workshops, learning modules, poster books, and other job aids and materials for distribution to CT&D customers and program participants.
• Develop Brand training programs as identified from Sales and Marketing teams focusing on Brand strategies and tactics which will ensure significant impact on increasing business.
• Facilitates Foundation (Phase I), Core (Phase II), and Continued (Phase III) Training Classes – skilled at group facilitation and group learning exercises.
• Designs and implements metrics to measure clinical training programs and products impact, effectiveness, appropriateness, and utility.
• Filters and distributes educational resources (i.e. clinical papers) to the CT&D customers and other appropriate audiences while remaining contentious of legal and regulatory parameters.
• Collaborates with all CT&D customers and resources: Sales, Marketing, Development, Medical Communications, Clinical, Legal, Regulatory, Library Services, etc. to ensure consistency, avoid redundancy, and that needs are met and leverage internal resources thereby ultimately, enhance training programs.
• Communicates appropriate Commercial Training and Development (CT&D) programs and resources to all customer segments to help support the Commercial Organizations strategic goals
• Participates as an active member on Commercial and Brand product teams
• Facilitation of “Selling Excellence” training programs that will enhance the effectiveness of the field sales organization
• Participates on CT&D internal training initiatives

...

Global Regulatory Leader

Accountable for regulatory management of a project(s) and leading a matrix team of regulatory professionals.

Primary Responsibilities and Accountabilities

• Accountable for global regulatory strategy and global regulatory deliverables for a PD project 
• Accountable for leading a matrix team of Regulatory Professionals, and for the RAFT deliverables.  Responsible for motivating and inspiring RAFT members
• Responsible for holding regular RAFT meetings, in accordance with RAFT guidance.
• Responsible for representing the regulatory function on cross-functional project teams (Lifecycle Teams).
• Responsible for representing the regulatory function on project specific matters to governance bodies
• Accountable for global regulatory Health Authority Interactions
• Accountable for managing decision-making, and conflict resolution surrounding regulatory issues within the Project Team and RAFT.  Responsible for ensuring appropriate escalation to functional management when necessary.
• Accountable for leading the RAFT on a PD project to:

• deliver strategic regulatory input to the lifecycle management of a project. 
• deliver specific guidance on regulatory issues such as legislation, guidelines, procedures to internal stakeholders (project team, regulatory function, governance bodies) 
• deliver integrated plans relating to regulatory submissions or specific functional projects 
• deliver regulatory submissions, in accordance with project timelines
• manage successful interactions with regulatory agencies and 
• analyse and landscape the regulatory environment for impact on the project and to brief internal stakeholders, as appropriate
• Responsible for sharing best practices within function to ensure efficiency and consistency across teams.
• Responsible for leading special regulatory projects/global process initiatives, as assigned.
• Responsible for acting as a change agent and role model within PDR by modeling best practices.

...

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.

...

Job Description (gRED ECD Onc Clinical Science Specialist [E4a])

Genentech is seeking a Clinical Science Specialist (CSS) with clinical and drug development experience in oncology to join the Genentech Research and Early Clinical Development (gRED) Oncology ECD organization and support Clinical Science deliverables for clinical trials and programs associated with the exploratory clinical development of novel anti-cancer agents within the Genentech portfolio. These programs span first-in-human Phase I studies through proof-of-concept Phase II studies in a variety of malignant disorders, and may involve collaborations with other Clinical Development teams at Genentech, corporate development partners, and external scientific/academic/clinical organizations. The optimal candidate will have the desire to proactively participate within a multi-disciplinary team of internal clinical and commercial colleagues and have the ability to interact with external experts and investigators.

Job Duties and Responsibilities:

Scientific Writing

• Draft Strategic Context Documents (SCD), Clinical Protocols, and Investigator Brochures, and coordinate the successful completion of documents with medical editing.
• Conduct literature searches, draft abstracts, draft safety narratives, draft background sections of clinical documents, and ensure that standardized disease/molecule protocol language is incorporated (e.g., eligibility, dose-modification criteria, risk language, key scientific statements). Track items for inclusion in protocols and ICF amendments and work with Medical Editing to ensure the completion of the protocol and any subsequent amendments.

Functional Activities

• Serve as a Clinical Science representative on cross-functional teams as assigned (i.e., Protocol Execution Team, Safety Sub-Team, Biomarker Sub-Team, cross-functional initiatives).
• Identify and implement processes to share clinical information across teams/molecules/indications.
• Develop study-specific listings with data management representatives and conduct frequent clinical data listing reviews.
• Working closely with the gRED medical monitor, serve as primary point of contact for, and triage, clinical study inquiries from site staff, CROs and site monitors regarding the study protocol, modifications to informed consent, and patient-specific questions. .
• Partner with Data Management for CRF design, instructions for unique CRFs, and data quality plan.
• In conjunction with a Medical Director, create and or review clinical slides for internal and external meetings (i.e. Investigator meetings, PSSV and SIVs, Study Coordinator and CRA training, Advisory Boards, scientific meetings). Develop and QC data tables with biostatisticians to support these activities.
• Participate in tracking/analysis of any potential safety events within a given trial and across trials for assigned program(s).
• In conjunction with Biostats and Medical Director review appropriate analysis and reporting documents (i.e. clinical study report, analysis plan, etc.).
• As assigned, participate in development of the long-range strategic plans for the assigned program(s).
• As assigned, participate in Clinical Science assessment of in-licensing opportunities.
• As assigned, mentor and/or train new Clinical Science Specialists

...

The North America Commercial Group generates $13B in sales and includes 4000 employees, 1500+ reps, and major sites in South San Francisco, Nutley, Indianapolis, Vacaville, Hillsboro, and Mississauga.  The US affiliate is organized into Business Units such as BioOncology, Immunology/Ophthalmology, Virology, and Metabolism as well as organizations like Business Operations, Managed Care, and Customer Operations.  Since 2008, all major technical solutions and components supporting Genentech US Commercial Operations were replaced or upgraded, then extended to support Roche Canada.  The Commercial IT team continues to implement innovative technologies to best enable the business stakeholders.

The Programmer Analyst will provide technical expertise to the Application Services - Sales & Marketing team supporting the North America Commercial Group.  This position focuses on the continuing evolution, implementation, and support of existing and new vendor-based systems to support critical business processes.  The Programmer Analyst will work with a Poland-based development team and onsite contractors as needed to complete deliverables.  

Key Responsibilities:  

• Participate in business process analysis, use case creation, and requirements definition.
• Responsible for designing, prototyping, developing and unit testing solutions for projects and maintenance & enhancement releases.
• Create and maintain technical specifications, system interface diagrams, unit testing scenarios and system support documentation.
• Follow best practices and standards to ensure technical compliance.
• Provide root cause analysis to resolve complex issues as part of support.
• Work on multiple priorities at the same time and manage the work/time effectively.
• Demonstrates accountability by contributing to the completion of assigned tasks.
• Participate in projects as assigned.

...

Senior Finance Manager 

JOB DESCRIPTION:

Position is dedicated to supporting the financial management of the South San Francisco Production Business Unit (BU). The position will report to the Associate Director of Finance for South San Francisco Production and is part of the Technical Operations Finance group, which is charged with the financial stewardship of Genentech's Technical Operations organization.

MAJOR RESPONSIBLITIES

Responsible for the financial planning, analysis, and reporting activities of the South San Francisco Drug Product Manufacturing operation. Act as point of contact between the operating group and the finance organization. 

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.
• Actively participate in development of new business systems and metrics, working with the Technical Operations Finance and Corporate Accounting organizations as necessary to define and implement. 

Planning and Analysis

• Work with operations teams to provide input on the development and tracking of appropriate metrics and goals for planning horizon. 
• Lead business partners in the execution of planning exercises (forecasts, budgets, long-range plans): 
• Coordinate efforts of business partners to prepare operating expense, headcount, and capital forecasts so that all submission requirements and all deadlines are met. 
• Analyze budget forecast proposals for strategic consistency and suggest modifications as appropriate. 
• Provide support for all presentations and submissions. 
• Identify and execute opportunities to improve operational results. Partner with Business Unit management to achieve targeted costs and continuously improve.
• Analyze spending and cost of production monthly and provide direction to BU management using SAP. 
• Develop financial decision frameworks for operational issues and lead analysis through final recommendation. 

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 BU 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. 

MAJOR SKILLS TRAITS:

• Demonstrated analytical acumen and problem-solving skills.
• Independent self-starter and proactive leader. Seeks to continually improve business processes. 
• Strong communication and presentation skills and demonstrated success building partnerships across organizational boundaries (within a manufacturing environment desired). 
• 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.

...

The Sr. Finance Manager plays a pivotal role providing financial support for Global Biologics Technical Operations (PTB).  The Biologics Operations manufactures over 70% of worldwide Pharma revenue and is the primary supplier of clinical production.

This position reports to the Head of Finance – FMTB Financial Planning & Analysis and Accounting and supports the financial planning and analysis of 11 manufacturing sites in 9 locations and $2.5B of spending. 

This is a high-profile, global role that interfaces with senior management and cross-functional finance teams such as Supply Chain, Quality and Operations.  

Specific Responsibilities:

• Support forecast, budget and long range planning process for PTB, coordinating with finance teams across US, Singapore and Europe.  Produce executive updates and analyses.
• Provide support to local Genentech manufacturing finance functions in planning activities, such as financial systems interface (TM1) and process management.
• Partner with global finance teams to explain underlying business drivers on variances and alert management on risks and opportunities. 
• Consolidate, analyze and communicate financial performance for global Biologics.
• Collaborate with financial systems team to improve financial models, processes and analyses.
• Business partner with several leaders on forecasting and reporting their cost center budgets. 

...

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.

...

Summary:    

 

This position serves as an important conduit within the broader organization to ensure a culture of compliance through well-thought out, actionable, aligned and achievable compliance related processes. Given the nature of the group's work, incumbent will communicate and interface with a host of internal cross-functional partners, both within gRED and other Roche functions; identifying key performance indicators, areas for improvement and ensuring compliance with current regulatory policy, legislation and guidance. The Quality Specialist will actively contribute to the development and implementation of Standard Operating Process / Procedures, tools, and templates for application in clinical research and provide and interpretative guidance of such within Clinical Operations and the broader gRED community. 

This is achieved through:

• Proactively identify and manage changes in controlled processes and procedures as the organization evolves, industry practices change and/or regulations change to assure high quality standards with applicable laws, regulations, guidelines and Roche policies.  

• Working collaboratively with all internal and external business partners and key stakeholders to assess clinical business systems and processes and provide input on any unique business requirements utilizing strong interpersonal, influencing, and negotiating skills.

• Identifying and anticipating potential problems impacting the ability to meet business goals; developing and implementing methods of improvement and resolution in a pragmatic and effective manner.

• Staying abreast of relevant laws and regulations that affect organizational quality and ability to remain in a state of regulatory compliance 

• Proactively communicating and educating others regarding such laws and regulations

Key Responsibilities:

• Partner with other departments interacting with Global & Regional functions including, but not limited to: Drug Safety, Quality Assurance/ Risk Management, PD Clinical Operations, Healthcare Law, Corporate Group & Risk Advisory, Medical Affairs to ensure appropriate cross-functional SOPs, Policies or Work Instructions are in place. 

• Facilitate SME involvement and partner with global and cross functional teams in the development, review and implementation new/updated controlled documents (Policy/SOP)

• Serve as a key contact for communicating controlled document and policy changes within/across the gRED organization 

• Provide direction, and guidance to study teams to address quality issues, concerns and or potential regulatory compliance risks       

• Participate in the development and execution of GCP, SOP or Policy related training 

• Provide support and guidance during and following internal audits and external regulatory inspections (as required).

• Provide consultative guidance on business initiatives involving new systems, processes, procedures, regulations and innovative tools for use in clinical research activities.

• Facilitate the process of continuous process improvement and support internal and global cross functional initiatives by analyzing “to be” processes; forms, templates and related process documents to ensure alignment, accuracy, and adherence to relevant internal/country/local legal and regulatory requirements.

 

• Liaise with internal stakeholders and global quality partners to ensure strategic quality risk assessments are completed and provide oversight to gRED management and personnel on contracted service providers to ensure services meet business needs (quality deliverables and alignment to regulatory requirements)

• In partnership PD Quality, identify, interpret, and disseminate quality and compliance related trends, expectations and compliance requirements to leadership and respective governance bodies. 

• Challenge inefficient processes and leverage compliance and maintain highest levels of awareness, expertise in international GxP regulatory requirements, and project-specific procedures applicable to the clinical trial methodology

• Serve as consultant to management and internal/external spokesperson for the organization on matters pertaining to its policies, quality plans, objectives and business goals

• Provide regular u...