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.

 

...

Responsible for producinginnovative biotherapeutic medicine by interfacing with highly automatedproduction systems and controls in cGMP manufacturing environment, and maintainareas in high state of inspection preparedness. Operates production equipment for cell culture or purification that mayinclude culture growth, process monitoring, sampling, harvesting, purification,formulation, freeze thaw and transfer.  Performsmedia/buffer solution preparation operations. Maintains records and clean room environment to comply with regulatoryrequirements utilizing current Good Manufacturing Practices (cGMP) and StandardOperating Procedures (SOP).  Responsible for being proficient in two or morefunctional areas and applies expert knowledge of mechanical, scientificprinciples, processes and biopharmaceutical processing equipment.

• Provide coaching and training on best practices and compliance toSOPs.
• Prepare solutions for the production process.
• Participatein continuous operational improvement.
• Providereports to management summarizing goal unit attainment.
• Work with coworkers and supervisor to effectivelytroubleshoot equipment and process issues.
• Understandsthe theory, concepts, and regulations behind biopharm technology andprocesses. 
• Astrong knowledge of at least one manufacturing department with an understandingof process impact of other areas.
• Anticipatespotential problems and takes preventative action.
• Requiresjudgment to know when it is necessary to consult with supervisor and/or supportgroups. 
• Understandshow own actions impact others and uses this information in decision-making.
• Operate systems that clean and sterilizetanks and filtration systems. 
• Prepare solutions for the production process.
• Review documentation and check allcalculations (e.g. tickets, labels, equipment reading).
• Trouble shoot equipment and processproblems.
• Comply with safety requirements, cGMP,SOP and manufacturing documentation.
• Use of automation to perform production operations.
• Provide support to Manufacturing to meet production demands.
• Operate automated systems for equipment operation.
• Assemble and prepare equipment for production.
• Exhibit detail oriented documentation skills.
• Communicate effectively and ability to work in a teamenvironment.
• Exhibit professional interpersonal skills. 
• Work with coworkers and supervisor to effectivelytroubleshoot equipment and process issues.
• All employees with jobs that require access to theWarehouse must be able to pass the Transportation Security Administration (TSA)Security Threat Assessment (STA).
• Follows established safety and environmentalguidelines and procedures for all work performed.  Immediately reports safety and environmentalincidents including injuries, illnesses, near misses, and safetysuggestions.  Fosters a positive safetyculture in which no one gets hurt.
• Operate fermenters, centrifuges, otherharvest systems and protein purifications units.
• Operate and clean fixed tank and filtration systems.
• Operate large scale column chromatography systems.
• Operate small-scale cell culture areas and systems by operatingcleaning, set up, and maintaining 20L batch reefed fermenters; inoculating andmaintaining spinner seed cultures using aseptic techniques, maintaining cellbanks; and performing general seed lab operations.
• Perform CIP and SIP. 

...

Genentech's Medical Affairs organization' mission is to serve as the bridge between clinical development and clinical practice to support the appropriate utilization and access to all our medicines, by generating and communicating compelling scientific evidence with healthcare professionals and payers. 

• Develop medical strategies based on strong scientific rationale for pre-launch and marketed products in Endocrinology, with a focus on growth disorders

• Establish standards for all Medical Affairs activities, including Sponsored Trials, Supported Trials, Registries and Exploratory Data Analysis of internal and external data bases, publications, medical education, medical communication, Advisory Boards and promotional review.  

• Participate on Franchise Leadership Teams contributing the medical perspective to franchise business strategies and evaluation of new product/development ideas. 

• Work in a cross-functional/matrixed environment, interfacing with Development and Global Medical Affairs personnel to provide the US Medical input into Development programs and Global Medical Affairs strategies

• Responsibility for the medical affairs budgets for the Growth Disorders Franchise to ensure adequate resources and their effective allocation. 

• Interact and manage relations on behalf of Genentech with Key National and Regional Thought Leaders in Endocrinology. 

• M.D. with board certification/eligibility in Endocrinology

Technical/Functional Competencies 

• Relevant therapeutic area experience in Endocrinology (5 or more years, inclusive of academic experience)

• Relevant biotech/pharmaceutical industry experience (2 or more years) strongly preferred

• Considerable experience in the principles and techniques of data analysis, interpretation, and clinical relevance

• Comprehensive understanding of product and safety profiles

Core Competencies / Other Key Behaviors

 

• Participate on cross-functional teams for evaluation of new products/ development ideas and implementation of franchise business strategies.

• Scientific leadership 

• Leading Teams

• Collaboration and Teamwork 

• Excellent Judgment and Analytic skills 

• Drive for Results

• Effective Communication 

• Integrity

• People Development 

...

Our group is searching for an experienced and dynamic Device Development/Product Introduction Engineer to be responsible for design for manufacturability, assembly, testing, and the interaction between product design and manufacturing process development of parenteral drug delivery devices.   This includes design, testing and transfer to production activities for a wide range of combination products, along with providing technical support to partners working on validation, quality and program management.

We are looking for a candidate that has the ability to affect change, deal with uncertainty and deliver to commitment in high quality manner.  The environment is challenging, results oriented, and rewarding with opportunities for impact.


...

A position is available in the Protein Analytical Chemistry department for a Scientist with relevant analytical skills related to the biopharmaceutical industry. The candidate must have strong knowledge and hands-on experience in analytical characterization of recombinant therapeutic proteins, development and validation of quality control methods, and application of emerging analytical technologies. The candidate should have experience in or be highly familiar with the development of analytical methods covering a wide array of techniques such as HPLC, capillary electrophoresis (CE) and mass spectrometry. The Scientist will design and execute analytical characterization studies to identify critical quality attributes and enable a commercial control system for a late stage product. A strong understanding and knowledge in analytical control strategy development and cGMP is highly desirable.

The Protein Analytical Chemistry department is part of Genentech's Pharma Technical Development Biologics organization and is responsible for method development and detailed structural characterization of recombinant proteins to support the clinical and commercial biotechnology product portfolio.

...

Are you ready to create something that makes a real difference in people’s lives, rather than just a cool widget for the next internet startup?  What about creating tools that enable scientists and engineers to optimize cutting edge biochemical manufacturing processes that produce live-saving medicines for cancer and other unmet medical needs?

We do all of that at Genentech.  We have a small team that utilizes both agile and waterfall approaches (when it suits us) to create novel tools in a biotech manufacturing environment.  We create applications that simply do not exist in this industry – but are vitally necessary to advance the science of delivering new drugs that save lives.

We need someone to help develop and maintain applications in Perl, Ruby, ASP.NET, and some other platforms.  We do not require experience in all of these technologies, only a willingness to learn and expand your toolkit.

You will be responsible for the development and maintenance of the systems you build. You will be required to work both independently and also be part of a team. You are an excellent communicator and have a can-do attitude.

Key Responsibilities:

• Working with small teams, design, develop, test, document and implement GxP solutions based on customer requirements and translate them into functional solutions
• Provide deep technical expertise over a broad set of current technologies and platforms and mentor other team members in these technologies
• Deploy new software enhancements, troubleshoot production systems, contribute to root cause analyses and provide excellent customer service to a 24x7 manufacturing operation
• Work with a variety of in-house developed, commercial off-the-shelf (COTS) and open source software

...

The successful candidate will be a key member of the Cross-Portfolio Analysis & Communications (CPAC) team within PPP/Pharma Portfolio Management. The CPAC team provides management with late stage and cross-portfolio information that enables a shared understanding of the portfolio, and robust analytics that offer unique insights on Roche’s direction, strategic alternatives, and ultimately contribute to effective corporate decision-making.

Responsibilities:

• Representative responsibilities associated with the role are detailed below:
• Develop analytics around portfolio spend, future portfolio projections and “what if” scenarios
• Assess Roche’s performance versus competitors across various R&D-related metrics
• Provide guidance to, and participate in, cross-functional initiatives on R&D productivity, cost and valuation metrics, and long-range planning
• Participate in preparation of quarterly reports for senior management on progress of portfolio and implications

Job Skills and Expectations

• A strong understanding of pharmaceutical/biotech industry, drug development trends, and business strategy
• Financial acumen and understanding of commercial and development forecasting methodologies
• The ability to analyze and draw conclusions out of large, complex data sets and articulate the key findings to management and functional leaders
• Strong oral and written communication skills
• Innovative mindset and comfort with ambiguity
• The ability to build cross-functional partnerships and engage in (and at time lead) cross-functional initiatives
• A desire to make a difference and commitment and drive to see things through

...

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.

...

Product Manager / Senior Product Manager

The Product Manager, Lytics Cathflo Marketing reports directly to the Group Product Manager and is responsible for:

Management of all peer-to-peer Cathflo programs including speaker's bureau, Cathflo Nurse Trainers, Cathflo Nurse Liaisons and national webinars.
Development of relevant medical education content and patient case studies for inclusion in peer-to-peer programs. Evaluation of nurse thought leader engagement strategy in partnership with the field and other internal partners.
Evaluating new means of marketing broadly to nurses, with a goal of driving an increase in habitual CVAD line assessment. Planning and execution of annual advisory boards in support of Cathflo, as needed. Contribution to the development and execution of the 3-year brand plan, and the 1 year tactical plan for Cathflo.

The successful candidate must have:

• Proven strategic agility in a complex marketplace
• Demonstrated experience in the development and execution of a sales or marketing plan
• Proven ability to partner effectively with field sales and sales leadership
• Considerable skill in influencing without authority
• Ability to provide rationale-based, succinct and persuasive oral & written communications
• Working knowledge of product development, regulatory and clinical affairs
• Demonstrated ability to establish thought leader and other relevant stakeholder relationships
• Strong analytical and project management skills, including previous experience working with budgets and analyzing market research results

...

The Quality Engineering manager works independently and provides oversight of quality engineering activities during design development. Be the quality engineering subject matter expert during device development, manufacturing, technology and associated verification and validation. 

Job Responsibilities:

* Works closely with Device Development and device CMOs to assure that combination products maintain their requirements and specifications and are compliant with the Quality System

* Liaises with technical groups to review and revise specifications based on design and/or process changes

* Supports root cause analysis in the implementation of corrective actions

* Responsible for continual improvement activities and liaises with experts to apply appropriate improvement tools

* Provides technical consultation on the development of fixtures, methods, test equipment, and tooling in order to continually improve process and products 

* Establishes quality inspection processes and supports quality activities to ensure that products and processes comply with the relevant requirements of the quality management system.

* Supports internal/external audits and vendor qualification, including closing out audit findings and determining proper corrective and preventive actions.

* Responsible for planning, organizing, and managing the overall testing activities of quality functions.

* Collaborate on and /or author policies and procedures and act as a trainer / subject matter expert on applicable quality systems, standards or business processes (as required). 

* Set personal performance goals and provide input to departmental objectives and establish work priorities to meet targets and timelines. Maintain current status on all required job related training and strive to continuously improve knowledge and skills in quality, compliance and technology.  Perform any other tasks as requested by Management to support Quality oversight activities

* Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.  

...

The Advisor PEM advises and supports the Medical Unit Head of Operations. The Advisor PEM has the operational responsibility for the performance of assigned Medical Teams. This is a leadership role with responsibilities for providing input into design, development and execution of post-marketing activities; supporting medical teams in the mitigation of risks and the delivery of successful outcomes.  Advisor PEMs are assigned PEM responsibilities for multiple and/or complex or large-scale multiple molecules/products with potentially multiple indications. Advisor PEMs are also expected to take a leadership role in gMed initiatives, when needed, act as a substitute for his/her manager, assist his/her manager and others with on-boarding, training and coaching new PEMs, and if appropriate, have 1-2 direct reports.

Responsibilities:

The areas of major responsibility include, but are not limited to the following:

• Responsible for the day-to-day operations of the designated Medical teams.

o Works closely with medical directors and other cross-functional partners /teams to support the development of short and long-term medical strategy, plans, tactics, budgets and other resource plans for multiple and/or large-scale or highly complex molecules

o Co-leads and facilitates all medical team planning and decision-making

o Identifying and initiating problem solving strategies when operational issues arise and escalates issues if unresolvable.

o Plays a lead role, working with finance, legal and other partners to evaluate medical plans, develop budgets and determine any legal or other administrative implications or requirements necessary to execute projects.

o Works with team members and other stakeholders to ensure alignment of gMed strategies, plans and objectives with Genentech strategies.

o Co-leads process to develop the medical plan vision, strategy, scope, milestones, risk assessment and management strategies, project investment requirements and success metrics 

o Supports medical directors and/or plays a lead role in development and delivery of critical presentations to communicate, obtain inputs into and approval for medical plan strategies, objectives, tactics and resource requirements 

o Works with cross-functional medical team members and other partners/stakeholders to implement project plans to ensure timely, on-target, and within-budget execution

• Builds and maintains relationships with key internal/external customers, partners and other stakeholders, includes global partners, external strategic partners, etc.

• Works with manager and other team members on key departmental projects, including standardized gMed and/or MU specific Planning & Execution SOPs, other protocols, processes, systems, tools, etc. 

• Oversees all project/program phases to help ensure on-time, on-target and within-budget execution 

• Conducts proactive risk assessment and change control for all assigned projects/programs

• Complies with all laws, regulations and policies that govern the conduct of Genentech activities

...

Data Management - Field Operations Manager
Data Management – Field Operations Manager is a subject matter expert and lead contact for FOIM’s IMS sales data support process. The Data Management – Field Operations function is responsible for the processing of quality, accurate and timely sales information used by Genentech Commercial Operations. This is a critical role responsible for working with IMS to ensure accurate and timely data is being delivered to Genentech. Key responsibilities include ensuring product/market definitions, communicating the impact of market events, and data issues to FOIM teams. This role is also responsible for determining and monitoring the Genentech data supplementation process and coordination with IMS to ensure the process runs smoothly. The position requires working closely with internal and cross-departmental teams to ensure sales and customer data meets quality standards for field incentive compensation, reporting and analytics. Timely and clear communications to internal stakeholders is critical. Proactive communication with the broader organization around data or market events resulting in data anomalies is required. A successful candidate will possess advanced business knowledge in pharmaceuticals/biotech and the impact of sales data to quickly understand and identify issues to with focus process improvement. The Data Management – Field Operations Manager will be responsible for operations and projects; that are impacted by IMS data and includes file configurations, definitions, products, recruitment of suppliers, and market and data events that impact data coverage or granularity of the data. Responsibilities would also include coordination deliverables with other teams, attending to ad hoc data requests, and leading and/or participating in special data projects impacting FOIM Data Management – Field Operations. Like other Data Management teams, Field Operations works closely with a host of internal partners, including Genentech’s Commercial Operations Informatics (gCOI), as well as external data or IT vendors/consultants. Incumbents in the Data Management – Field Operations Manager role, as all other employees, are fully accountable for compliance with all laws, regulations and policies that govern the conduct of GNE activities.

1. Compliance, Knowledge & Skills

• Follows all laws, regulations and policies that govern the conduct of all activities. Is accountable for being fully knowledgeable of all relevant policies and for abiding by these
• Does not compromise ethics or integrity, or undertake legal risks while pursuing business goals
• Asks questions when in doubt
• Demonstrates leadership among peers and subordinates by consistent application and modeling of the appropriate compliance, behavior and conduct
• If applicable, is required to obtain and maintain full proficiency and knowledge of disease state, product and other aspects or issues as provided for and mandated by the company

2. Planning & Development

• Act as a subject matter expert and a lead contact for FOIM Data Management – Field Operations IMS data sources and Genentech supplemented files production processes and projects
• Stays abreast of Commercial Operations and other business developments, to include external marketplace changes/developments, and uses where appropriate data to support recommendations to improve processes
• Recommends new opportunities to his/her manager and other business partners/stakeholders. Where approved, leads the development/implementation process for such new opportunities
• Works with manager, team members, gCOI, others in FOIM, other internal customers, partners and stakeholders and external vendors to review business requirements for Commercial Operations validation and sales data and plan for any new or updated data sources, systems, databases, interface, processing methods and/or reporting mechanisms
• Works with manager, team members and others to develop appropriate departmental plans and goals to address customer requirements. Where applicable, develops detailed project plans and participates in evaluating necessary resources 
• Participates in other planning and development meetings within FOIM and other Commercial Operations groups
• Participates in departmental policies & procedures development, which may include development and documentation of Standard Operating Procedures (SOPs) or other relevant guidelines. May take the lead role in departmental policies & procedures development, as assigned
• As appropriate and assigned, independently leads departmental or customer projects 

...

Provides clinical oversight for a variety of projects, in consultation with his/her Medical Director or Senior Medical Director :

·         Works with a host of internal and external partners and stakeholders in the implementation of clinical trials for assigned drugs/indication

·         Provides scientific input into and/or coordinates the development of specific clinical trial documents for review and discussion with Medical Directors* (e.g., protocols, charters, safety monitoring plans, process documents, etc.) including disease and/or treatment registries

·         Participates in the identification of appropriate external investigators

·         Oversees the clinical trial implementation, ongoing monitoring and evaluation, working closely and regularly with external investigators and Clinical Operations. Active Member in Study Management Team for assigned drugs/indications

·         Develops and cultivates relationships with external partners such as clinical investigators, clinicians, scientists and KOLs, as well as cross-functional partners in Clinical Development, Commercial, Legal and Regulatory.

·         Supports his/her manager in developing clinical components of presentations* for clinical trial investigator meetings

·         In collaboration with his/her manager, coordinates the preparation and reviews data outputs for reporting documents* where appropriate (e.g. clinical study reports, analysis plans, etc.) with the CRO, the Medical Affairs Biostatisticians and his/her Medical Directors

·         Monitors project progress and is expected to proactively identify any issues or challenges and recommend and implement strategies to effectively resolve such once approved with his/her manager

·         Works closely with his/her manager, the publication team and Clinical Operations to complete associated publications, reviews draft publications*.

·         Keeps all partners abreast of projects progress throughout all applicable intervals

·         May also participate/coordinate collaborations with external stakeholders

(e.g. cooperative groups, other companies, etc.) on development and implementation of

approved clinical projects.

·         May coordinate, liaise with internal and external providers for data mining activities

·         Helps his/her manager provide data outputs requested for safety and/or other relevant sections of IND annual reports, if these sections and reports relate to assigned drugs and/or indications*.

·         May interact with NCI or other agency, as appropriate, with supervision from his/her manager

 

¿ Stays abreast of internal and external developments (scientific, clinical, commercial, competitive, legal, regulatory and like) as such developments may implicate or otherwise impact the implementation of the medical plan of the assigned drug(s)/indication(s). Includes attendance at major scientific conferences, participation in competitive intelligence activities, and review of published literature

...

Job Responsibilities:

• Provide hands-on maintenance, repair, fault diagnosis and troubleshooting of industrial electrical systems, including, but not limited to: VFDs, Soft and across the line motor starters, UPSs, Switchgear, Emergency Generators, Transformers, control systems, Standard and Emergency Lighting systems, etc.

• Safe operation of tools and testing equipment, and safe execution of work in the field.

• Timely completion of tasks and work orders with appropriate documentation according to applicable standards.

• Identify, anticipate, organize, and initiate acquisition of spare parts, safety equipment, engineering documents, service manuals, and test equipment.

• Ability to read and understand Electrical Drawings.

• Basic computer skills, with the ability to utilize the corporate intranet and applications, CMMS, and standard word processing and spreadsheet programs.

• Develop preventive maintenance and operational procedures for industrial electrical systems and equipment throughout the facility.

• Prepare and organize technical documentation, including red-lining documents to match as-built conditions.

• Coordinate contractors performing maintenance, repairs, modifications, and installation of electrical equipment.

• Inspect new installations and modifications by contractors and effect necessary changes to comply with company and industry standards.

• Communicate appropriately, verbally and in writing, with Engineering and other Plant department’s to ensure satisfactory performance of electrical systems.

• Represent Utility Operations on multidisciplinary project teams.

...

HCV Clinical Specialist
Territory: Richmond, VA and Virginia Beach, VA areas


The HCV Clinical Specialist, Pegasys Sales manages and develops long-term relationships with physicians and other customers for the customer accounts in the assigned territory. As such, Clinical Specialists represent the assigned GNE brand(s) and their approved indications; helping external customers such as physicians, nurses, etc. learn about the benefits of the assigned GNE brand(s) in relation to the applicable therapeutic area/disease state.

Reports to: Division Manager, Pegasys Sales

Example Duties and Responsibilities:
• Responsible for meeting or exceeding assigned sales targets
• Develops robust territory business plans
• Develops strong and long-term relationships with customers in all assigned accounts
• Presents the assigned GNE brands in a professional, compliant, ethical and effective manner;
helping external customers understand the benefits and use of GNE brands
• Monitors operating costs and compliance with territory budget
• Complies with all laws, regulations and policies that govern the conduct of GNE activities.

...

The primary responsibility of this position will be to focus upon clinical product planning for multiple molecules; which includes partnering with Clinical Operations to translate trial assumptions into drug forecasts, utilizing SAP/APO to develop supply plans and to align these supply plans with the Technical Development Team, and partnering with Master Production Planners (MPP) to ensure plans are converted into bulk, filling, packaging, and contract manufacturing schedules which meet customer requirements.  For Finished Goods, the CDSL is also accountable for generating a distribution plan to handover to the Global Clinical Distribution team and working with this group to ensure a seamless supply chain throughout our distribution network.  The CDSL will be knowledgeable of the costs and capacities associated with our manufacturing network, and will assist the MPP in developing recommendations to balance production requirements, customer service, and manufacturing capacity.  The CDSL will assist in the execution of our Clinical Demand & Operations Planning process, in capturing supply planning metrics and in developing/implementing strategies to drive improvement in those metrics; enabling the development of robust business processes and our ability to reach our department goals.

Responsibilities:
¿ Partner with Clinical Operations teams to develop drug forecasts based upon clinical trial assumptions, design, and timelines
¿ Leverage the Generic Forecast Assumption process to apply drug forecasts to future planned trials listed in Plansource
¿ Collaborate with Development Partners to understand partner demand and timelines for trials not being run by Genentech
¿ Initiate product definition forms to enable creation of new planning and execution items in SAP
¿ Utilize clinical forecast tools to consolidate all demand for Roche/Genentech, or CMO produced drugs as well as required Other Study Drug procurement
¿ Utilize SAP to create/communicate a Master Production Plan, a depot Distribution Plan and OSD procurement plan that meets global clinical demand, inventory targets, project budgets, and manufacturing capabilities
¿ Actively participate on TDT teams to ensure alignment of demand and supply plans with TDT development strategy and budget, and capture all project driven demand in SAP
¿ Lead cross-functional Global Supply Execution Teams to drive alignment of activities enabling drug to be packaged, released, and ready to ship; meeting trial First Site Activation goals
¿ Manage inventory and production orders for assigned products; monitoring inventory levels, firming production orders, controlling lot allocations, managing expiration dating
¿ Perform required Supply Planning activities & processes driving cross functional action to ensure all drug supply plans are achieved
¿ Participate in the S&OP process as necessary, leading cross-functional process improvement RCAs

...

Analytical Operations provides assay support for Process Technical Development in GMP and R&D environments.  The hire will be mainly responsible for performing HPLC, CE and LC/MS assays, data processing, and development of HPLC methods. Responsibilities also include assay reagent and instrument maintenance, and assay troubleshooting.  Position requires working closely with other members of the department in a team setting, as well as extensive interaction with other departments. Handling of biological and chemical reagents is required.

...

The Position:
Provide technical support and maintain consistent configuration, implementation, operation and support of an Integration Services Platform – Infrastructure Platforms (monitoring, inventory, automation, etc).

Responsibilities:

• Provides technical support and maintains consistent configuration, implementation, operation and support of a single Integration Services platform including:
• Implements new releases and sets up standards for operational management
• Monitors and resolves problems with Business Application operations.
• Configures and manages development, UAT and production environments.
• Administers and maintains support services.
• Configures implements and optimizes Business Applications.
• Manages incidents, problems, changes and releases
• Tunes capacity and performance
• Coordinates, tests and administers platform Security
• Complies with OLAs and Quality/Validation requirements
• Ensures ITSM framework, processes, tools and SOPs are implemented, utilized and supported end to end

Applies the processes above to the following Integration Services platform areas:

• Monitoring Solutions (NetIQ, others)
• Inventory Management solutions
• Automation and Provisioning solutions (HP Orchestrator)

Key Objectives:

• Business Application Installation and Daily Administration
• Business Application Performance Tuning
• Business Application Availability
• Support to ensure quick incident resolution
• Engineer new release and setup standards for operational management
• Standards and procedures are followed
• Understand and apply ITSM and process best practices
• Understand and comply with applicable ITSM roles and responsibilities
• Provide Support in measuring and continuously improving process performance and adherence to service level / operating level requirements.

...

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

...