Manager/Sr. Manager, Commercial Training & Development - Rheumatology

The Rheumatology Manager/Senior Manager in Commercial Training & Development (CT&D) is accountable for managing and leading a team of 5 Actemra and Rituxan trainers and support staff who develop and implement a learning & development curricula which supports CT&D, brand, and sales objectives. Managers/Senior Managers in Commercial Training & Development are accountable for ensuring the assigned team meets or exceeds their goals and objectives and maintains alignment and coordination with department and functional stakeholders. Key competencies include: building and leading teams, strategic agility, communication, and collaboration. Rheumatology, training, and sales experience preferred.

Example Duties and Responsibilities:

• Assesses existing learning & development curricula and offerings and compare/contrast with immediate-, medium- and longer-term business needs, strategic goals, other targets and anticipated results
• Works with others to build appropriate and aligned annual or longer-range learning & development plans that will support business partners and other stakeholders in Commercial Operations in achieving their strategic and operating goals, targets and anticipated results. May develop, manage or individually undertake a detailed needs analysis/data gathering process/project for key learning & development content/topics/subject matter; enabling self, team, department and overall function with detailed partner/stakeholder input
• Works with others to conduct internal business partner/stakeholder reviews of learning & development plans, specific programs and/or other activities; ensuring up-front internal client input into the shaping and ultimate development of aligned learning/development support
• Works with others to develop and implement an aligned learning & development communication strategy/plan/activities to ensure internal partners/stakeholders are fully updated and aware of all assigned learning & development programs and other offerings
• Periodically, as and when needed/requested or appropriate, delivers internal presentations to fully communicate team's offerings and support strategies
• Works with others to identify, recommend, and where appropriate/approved, implement new, creative, innovative learning & development offerings, techniques or other
• Works with manager and peers, and oversees team in such a way as to, continuously assess and evaluate learning & development plans and activities to ensure continuous, strategic alignment to meet or exceed internal business partner and other stakeholder needs and objectives
• Consistently monitors and supports team's work and associated work output. Regularly coaches, advises and gives further direction to help team members fine-tune and hone their work to meet or exceed assigned goals and objectives
• Ensures self and team members, where and when appropriate, seek regular internal client or other partner/stakeholder input into in-development work; does so to ensure maximum alignment to internal client needs, objectives and goals
• Consistently oversees the execution/implementation of team's work to ensure timely and best quality output. Manages similarly with any applicable external partners; ensuring their work is on-time, on-target and within-budget to meet or exceed assigned goals, objectives and other expectations
• Hires, develops and oversees the work of direct reports
• Complies with all laws, regulations and policies that govern the conduct of Genentech activities

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Purpose

To provide relevant, balanced, and timely evidence-based clinical information on Genentech products to managed care customers that make decision regarding drug coverage and reimbursement, .

Description

The Associate Scientist or Scientist for Managed Care Medical Communications (MCMC) is able to communicate relevant and timely clinical information on our marketed products and compounds in late development.  More specifically, this position is responsible for communicating effectively with external customers involved in evidence-based healthcare decisions including but not limited to managed care organizations, private and government health plans, third party payors, pharmacy benefit managers, specialty pharmacies, compendia publishers, guideline bodies and technology assessment entities.  The MCMC Associate Scientist/Scientist is expected to evaluate and interpret medical literature, abstract and write medical information in various response formats, conduct scientific and clinical presentations, and apply managed care concepts and knowledge to customize our services for managed care customers.  More specifically, an understanding of the comparative effectiveness research (CER) and health technology assessment (HTA) landscape is required, as well as the ability to review, assess and synthesize CER, health outcomes research and pharmacoeconomic evidence.  Medical information is prepared and communicated using many formats (response documents, formulary dossiers, slide presentations, compendia submissions, web-based media, scientific meetings, etc.).  This position is also involved in the review of promotional marketing materials intended for the managed markets and payor environment.  The MCMC Associate Scientist/Scientist shall effectively, appropriately, and responsibly use resources to support the use and access of our marketed products.  

The MCMC Associate Scientist/Scientist may contribute to departmental efforts to develop, implement or further improve business processes and operations.  This may include non-clinical and non-product types of responsibilities and activities such as systems and technology, training, quality assurance, writing policies and procedures.  Some business travel is expected.

Candidates should have a sound understanding of legal and regulatory topics to adequately describe the basis of Medical Communications (MC) policies and practice.  He/she must work effectively with members of the MCMC/MC staff and other internal customers that include but are not limited to: Medical Directors, Health Economics and Outcomes Research, Managed Care Liaisons, Project and Execution Managers, Regulatory, Legal, Managed Care Marketing, Field Managed Care, Medical Science Liaisons, Sales, Marketing, Access Solutions Reimbursement, and Corporate Partners.  This position shall partner with these entities to meet the information needs of managed care customers, contribute to corporate wide goals, and support the safe and effective use of Genentech products.

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Job Summary:

Perform analytical, biochemical testing and related activities to support QC operations

 

Description:

Must have flexible schedule, 4x10 day shift schedule. This role will require working major holidays.

Perform analytical, biochemical, and/or biological cell based testing of commercial and clinical in-process, drug substance, drug product and stability samples to meet standard lead times to support Quality Control Bioanalytical  / In-Process operations. 

Technical Duties/Responsibilities:
•Perform testing of routine and non-routine samples (e.g. Spectrophotometry, pH, HPLC) and document according to GMP.
•Review data and assess against established acceptance criteria
•Perform technical review of peer-generated data for basic methods
•Prepare data tables and graphs
•Identify discrepancies, participate in quality investigations and CAPA (corrective actions preventive actions) initiatives as needed.
•Receive and provide training
•Participate in assay transfer and assay validation.
•Perform equipment qualification / maintenance
•Prepare and maintain standards, controls, stocks, and cultures per established procedures
•Support the maintenance and compliance of operational areas.
•Assure and apply GMP throughout operations.
•Coordinate with customers to support operational activities.
•Support internal and external audits.
•Work to meet schedules.
•Identify and support resolution of technical problems.
•Actively participate in group and project teamwork; project and process improvements.
•Drafts protocols and reports under supervision.
•Meets scheduled performance of 95% on time.
•Perform other duties as requested by managers to support Quality activities.

Note:
•Position may involve use of reagents and other chemical compounds, including but not limited to acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compounds.
•Must be able to lift up to 10 lbs
•Repetitive pipeting

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The Principal Research Associate within the Biological Technologies group in Analytical Development and Quality Control will be responsible for all aspects of automation for all phases of clinical trials utilizing precision robotics.  The Sr QC Associate will support the execution of vendor IQ, OQ/PQ documents, write and execute instrument, assay validation protocols and IQ, OQ/PQ documents.  The associate will also support the development of R&D assays onto high throughput automation platforms utilizing liquid handlers, plate readers and high content analysis instruments.  The candidate will identify and evaluate new technologies and work collaboratively with different research and development departments.  Expectations will also include writing test procedures, SOPs, protocols, technical reports, and summarizing/presenting data.  Additional responsibilities may include presentation of data at internal and external meetings, as well as reports in support of IND/BLA regulatory filings, and supporting collaborations with other groups/sites.
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Purpose:

* The CMO Logistics Specialist acts as a liaison between Manufacturing Collaborations (MC), the CMOs and Genentech’s plants and logistics functions and is responsible for the detailed scheduling of orders and material movements to and from contract manufacturing sites.

* The Logistics Specialist ensures that all materials are available and delivered to the CMO on time in order to support scheduled production and releases orders to allow the CMO (through the MC Site Managers) to execute and to close orders upon completion. 

* The Logistics Specialist monitors the detailed production and shipping schedule in order to identify and resolve any variances that are occurring and coordinate required changes with the CMO. He/she also follows up to identify root causes for such variances and the corrective actions required to prevent their reoccurrence.

* The Logistics Specialist provide support to the CMO with all issues related to logistics and inventory management and provide guidance for material handling and any other questions that arise.

* The Logistics Specialist is responsible to the accuracy of inventory records and status in Genentech’s ERP system for all GNE-owned material that is at the CMO site and works with the CMO to update these records as material movements/consumptions occur.

Responsibilities:

Ensuring material availability for CMO production:

* Perform material requirements planning for multiple sites

* Monitors the detailed production schedule at assigned CMOs to identify material requirements and other preparations required to ensure readiness for production execution

* Coordinates with supplying plants to ensure alignment and understanding of CMO material requirements and shipping dates

* Ensures material availability and/or that production/delivery plans at supplying plants/warehouses are aligned with material requirement and shipping dates

* Coordinates with Quality to ensure that material release/disposition plans are aligned with required shipping dates and monitor progress of release/disposition process relative to schedule and shipping requirements

Transportation scheduling and coordination:

* Creates, converts and maintains Stock Transfer Requests (STRs) and Orders (STOs) and/or Purchase Orders for required materials

* Coordinates and/or schedule shipments with carriers and/or GNE Transportation.

* Works with GNE Transportation Import/Export functions to ensure that international shipments are properly coordinated with freight forwarders or customs agents and that materials clear customs without issues

* Coordinates with warehouse and other logistics functions to ensure that materials are prepared and shipped on time

Logistics schedule management:

* Identifies any delays during the manufacturing/release process that may have an impact on the scheduled shipping dates and works with relevant functions to avoid delays to scheduled delivery dates to CMOs

* Identifies, analyzes and escalates (to Master Scheduler or manager) schedule conflicts or delays that impact delivery dates to CMO 

* Coordinates any required changes with CMO

* Monitors the shipping/transportation of materials to/from CMO sites to ensure successful and on-time delivery.

Materials management:

* Manages and releases process orders to ensure a minimum of 7 days of orders have been released.

* Performs goods receipts of materials into CMO inventory locations upon delivery and monitors CMO inventory and material movements to ensure accuracy

* Performs regular inventor counts with each CMO and ensure updates GNE inventory records if necessary

* Allocates materials to production orders (in coordination with product planners as necessary)

* Provides guidance to CMOs and addresses questions and issues related to material handling, inventory and transportation

Performance management and projects:

* Monitors Key Performance Indicators (KPI’s) and supports root-cause analysis

* Executes all logistics process and other responsibilities in accordance with established business processes

* Identifies areas where existing business processes are not sufficiently defined/documented and/or require improvement

* Works with management to initiate improvement projects to address process deficiencies or improvement opportunities

* Collaborates with various groups and OE resources while working on cross-functional teams to support improvement projects and root cause analyses

* Takes responsibility for action items and tasks arising through such cross-functional teams and root-cause-analysis exercises and executes them to accomplish the team’s objectives 

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Adhere to all plant safety policies and procedures and proactively identify unsafe conditions
Perform safety and housekeeping audits as required.
Assist in set up, change over, and test run equipment for various-sized vials and packages as required.
Supporting the Operations Specialist, Maintenance, and/or outside services in the repair, maintenance, and calibration of Genentech systems as required.
Perform training of other Technicians.
Assist in the development of plant SOP's and training materials
Execute production recipes, check-in equipment, and perform material movements using automated computer software applications (SAP and MES systems).
Operate all formulation, sterile filling, inspection, and final vial packaging equipment in the plant.
Perform material handling in the plant as required.
Perform preparation of sterile components.
Assist in the cleaning, set-up, sterilization, and disassembly on a variety of processing equipment.
Perform bulk thaw, dilution, and formulation operations.
Performing manual inspection of empty vials and filled product with a focus on quality and efficiency.
Conduct environmental monitoring activities in the manufacturing areas as required.
Prior to start-up, during processing, and at the completion of the manufacturing process, perform all documentation and clerical functions to provide the proper accountability and traceability of components and finished product.
At the start and finish of each shift, report and make recommendations regarding equipment, supplies, required repairs,
Process concerns, safety concerns, and areas for improvement in reliability, yield, and efficiency.
Work effectively and efficiently in a team-oriented environment to ensure maximum and high-quality output.
Perform cleaning and housekeeping duties as required....

Manage selection, hiring and training of personnel on company and department policies, systems and processes.  Manage and communicate compensation related information per company guidelines.
• Ensure effective training program exists, improve with time, and are managed in compliance with PQS
• Ensure all employees have developmental goals and barriers removed to support attainment of goals
• Drive continuous improvement initiatives which simplify processes, enabling improvement in right-firtst-time, and appropriate prioritization of high compliance risks
• Manage and prioritize resources through IMPACT and in alignment with associated IMPACT prioritization priciples
• Ensure projects and initiatives are completed on time and within budget.
• Collaborate, influence and/or author department policies and procedures.
• At the cross-site and corporate level, provide leadership, vision and direction to:
­ address complex validation issues and influence network direction
­ develop and maintain validation programs  within cGMP regulations and the PQS.
• Monitor and control expenditures against the department budget.
• Immediately escalate potential quality or regulatory issues that may impact product quality or regulatory compliance.

Technical Duties/Responsibilities:
• Provide direction to subordinates in order to provide effective oversight of all validation systems lifecycle deliverables, per PQS.
• Interpret, implement and recommend improvements to validation policies, procedures, processes and workflows to meet quality and business objectives.
• Ensure that the Quality Leadership Team is aware of significant validation issues that may impact product quality or operations.
• Maintain and present validation systems health, representing the health of the program.
• Serve as technical and strategic resource for a range of validation assignments.
• Review and approve regulatory submissions and present validations to regulatory authorities during routine and pre-approval inspections.

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Summary:

Responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment; maintaining areas in high state of inspection preparedness, and utilizing business systems for inventory and process management.   Maintain records to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP). Participate in the routine production of mammalian cell culture products within the Vacaville Manufacturing Facility, operating in at least one of the following production areas:

• Cell Culture Manufacturing (CCM): Primary focus is the cleaning, sterilization and operation of fixed vessel systems for media preparation, fermentation, and harvest operations.
• Purification Operations Group (POG): Responsibilities include the operation and cleaning of fixed tank systems, the operation and cleaning of filtration systems, large-scale buffer preparation, and the operation of column chromatography systems.
• Centralized Manufacturing Services (CMS): Provide support to Manufacturing and Quality Control to meet production demands.  Duties include but are not limited to: CIP/SIP of portable and Freeze/Thaw tanks; clean, assemble, and autoclave 20L fermenters; prepare and autoclave manufacturing assemblies; autoclave solutions; clean, kanban, and deliver lab ware, glassware, parts and equipment; perform weighing and dispensing of components; handle and aliquot hazardous materials;  Provide quality materials and service to our customers.

Job Responsibilities:

• 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.
• Operate systems that clean and sterilize tanks and filtration systems.
• Prepare solutions for the production process.
• Review documentation and check all calculations (e.g. tickets, labels, equipment reading).
• Trouble shoot equipment and process problems.
• 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 team environment.
• Exhibit professional interpersonal skills.
• Work with coworkers and supervisor to effectively troubleshoot minor equipment and process issues.
  

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This position involves research, development and commercialization of technology for sustained delivery of therapeutic proteins.  The successful candidate will work as part of a multi-disciplinary team evaluating strategies for improved treatment options for ocular disease.  Responsibilities will include the design and execution of in vitro release experiments, evaluation of drug compatibility with formulation and device components, and research on mechanisms of drug release.  Effective utilization of technical staff to support these functions is required.  Projects may also include molecule engineering to enhance delivery effectiveness. Oral presentations to review bodies, preparation of written technical reports, and submission of external publications and patent applications when appropriate, are expected....

Genentech Partnering is seeking a Manager / Sr. Manager to join the Technologies Business Development Group. The Technologies Group executes strategic collaboration and licensing agreements to support therapeutic lead discovery and companion diagnostic development by Genentech.

Responsibilities will include working in close collaboration with internal scientific stakeholders to establish strategy and prioritization for accessing external technology platforms, defining key technology criteria, actively seeking out opportunities that meet criteria and coordinating due diligence activities.

The successful candidate will lead negotiations with prospective partners on behalf of Genentech, creating collaboration structures that align with scientific and business needs, and will be responsible for making deal recommendations to Genentech senior management.

The BD Manager / Sr. Manager will work extensively with scientists in Genentech’s Research and Development Sciences departments on technology assessments and due diligence and with colleagues in the Legal and Finance departments on deal structuring, financial valuations and contract negotiations.

This position will report to the Director, Head of the Technologies & Diagnostics Group in Genentech Partnering.

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Summary of Position:

 

The Clinical Safety Associate I (CSA I) assists in the clinical processing of adverse event (AE) information received by US Pharmacovigilance (USPV).  Responsibilities are performed under the direction of the USPV Manager. 

 

Job Duties/Responsibilities:

• Demonstrated knowledge of safety concepts, per ICH and FDA guidelines per drug safety reporting requirements.
• Performs a review of ancillary documentation accompanying ICSR reports and identifies pertinent clinical information for incorporation into the case narrative.
• Performs Data Capture and Quality Review for all molecules and serves as a back up for additional projects.
• Identifies and initiates requests for case follow up for clinical trials and post marketing adverse events.
• Works with Submissions Team Responsible to properly identify US regulatory reporting requirements.
• Demonstrates a general understanding of appropriate labeling documents for assigned project(s).
• Demonstrates knowledge and understanding of safety exchange agreements (if applicable).
• Participates on Study Management Teams (as applicable)
• Assists in the development of drug safety presentation for investigator meeting presentations.
• Assists in clinical trial reconciliation process (as applicable).
• Organizes work load to ensure compliance with regulatory timelines for ICSR reporting.
• Ensures departmental workflow processes and timelines are followed. 

Competencies Identified for Success:

• Works effectively as a team member and promotes collaboration
• Demonstrates initiative and accountability
• Strong organizational skills, detail oriented, ability to adapt to change
• Confident decision maker

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Sales Compensation Administration - Analyst / Manager

The Sales Comp Administration - Analyst / Manager role is to support the Sales Operations Incentive Compensation team for all business units / sales forces in administering Sales Incentive Compensation Programs which includes ad hoc analysis and reporting. As such the Sales Comp Administration - Analyst / Manager will be responsible for all sales compensation administration aspects including the maintenance of all sales force reference data, variable pay information, and compensation plan information within the compensation systems (TrueComp) and Incentive Compensation platforms. Additionally they will work with the Business Unit Comp Managers to collect plan design information and be responsible for the oversight of development and testing of compensation plans and rules in TrueComp. He/She will support and maintain the monthly sales and goal validation process, which requires critical thinking and problem solving skills. Candidate will also manage department SOPs, prepare department activity timelines, maintain documentation for various purposes such as program policies, eligibility, auditing & OCM purposes. Candidate will also support multiple supplemental incentive programs including the management of processing guidelines to ensure accuracy and consistency including application design & management. He/She will also help manage awards program documentation, criteria, history, inventory, etc. He/She will maintain content on IC Portals and facilitate process/data management with vendors. Candidate must have SQL skills for querying data and a basic understanding of sales compensation philosophy. Candidate will proactively coordinate with internal partners to ensure data accuracy, optimize operational processes and meet aggressive timelines. Provide adhoc support and analysis, including running queries and producing reports (using Access, Brio, Toad or other sql tool). Strong technical, stakeholder manager and communication skills are required.

 

Key Responsibilities:

 

- Primarily responsible for the administration and management of all sales incentive compensation administration deliverables including oversight of system configuration for IC plans, reference data (e.g. eligibility), timely and accurate payout processing, supplemental incentive programs, reporting and reference data management for all brands.

 

- Partner with Sales Operations Managers, Vendors and/or the Information Technology team to define data and reporting needs in support of the IC payout process and supplemental incentive programs.

 

- Collaborate with various internal and external stakeholders to ensure fairness and consistency in the implementation of and adherence to program policies.

 

- Communicate with field sales management in support of the sales incentive program payout process and provide supplemental incentive programs summaries.

 

- Development communication and reporting materials to support IC administration activities and status reports.

 

- Comply with all laws, regulations and policies that govern the conduct of GNE activities....

 Responsibilities:

This position is for a Principal Engineer/Principal Manufacturing Technical Specialist reporting to the Associate Director of Technology Validation in the South San Francisco Production Technology Department.  The candidate will independently lead highly complex compliance and transformational validation program projects.  The candidate will also be expected to lead site implementation of complex multi-site CAPAs and quality system deployments.  These projects require close collaboration with site Manufacturing, MSAT and Quality and other functions as well as network colleagues and corporate quality functions over the course of multiple years.  This candidate will sit on the Technology Validation Leadership Team and will assist the Associate Director in developing group goals and development plans.  The candidate must provide mentorship and direction to staff on interpretation of the Roche Quality System requirements, execution of the Qualification Lifecycle and Qualification Strategies for highly complex projects.  This candidate will also be responsible for representing Genentech in agency inspections and audits.  They will participate in network teams developing quality system approaches.

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The Position

We have an opening for a bioinformatics scientist to support development, regulatory, and discovery needs for infectious disease therapeutics. These include deep sequencing of viral and bacterial pathogen DNA from clinical trials to discover and analyze resistance mutations, analysis of host-pathogen interactions in clinical samples and preclinical models, and genomic analysis of both individual bacterial species and bacterial communities. Contribution to regulatory filings will be expected. Close interactions with bioinformatics and infectious disease scientists will be required to achieve these goals. The successful candidate will become an important member of teams developing breakthrough and life-saving therapies. High levels of drive, innovation, attention to detail, independence, and accountability will be required for success, along with flexibility to work with diverse teams that encompass all aspect of drug development. There will be opportunity and expectation to develop new computational methods, discover fundamental new understand and actively publish research results.
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The Records and Technology Manager will focus on electronic records management.  The purpose of this position is to supplement the Corporate Records department at Genentech that develops policy and consults on information issues, provides some operational support, and develops and delivers training on records management topics.  We expect close collaboration with the Genentech team, and with Roche global partners and stakeholders.

The Records and Technology manager will be responsible for developing strategies to apply records management principles to both structured and unstructured electronically stored information throughout its lifecycle.  The candidate needs to be knowledgeable about records management principles and have a deep understanding of systems that enable people to create, use, find, and share information such as document management systems, databases, collaboration applications, archive platforms, email systems, and cloud computing.  The candidate will be knowledgeable about emerging technologies and be able to identify records management concerns.  Some timely topics include system decommissions, email management, retention and lifecycle management of data in collaborative systems, application of retention periods to electronic records, and recommended formats and other issues related to long term preservation of electronic records.  The candidate who assumes this role will also oversee the staff managing the offsite storage services and application. 

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The Project Manager position will work in the Operations & Business Infrastructure function and is responsible for planning, executing, evaluating projects according to predetermined timelines & budgets, and ensuring quality control throughout project life cycles. The primary responsibilities include, but are not limited to, the following:

• Provide business and project management support across a broad range of projects in Medical Affairs with primary focus on providing support to the Field Medical Teams (FMT)
• Build and manage the FMT Strategic and Operational Plan, working with key internal stakeholders to enable effective evaluation of current gaps, future needs, prioritization and resource alignment/allocation
• Perform project budget and work plan reviews, project alignment and prioritization activities and resource utilization analyses
• Partner with IT function and/or work with project sponsor and stakeholders to complete project charter outlining scope, goals, deliverables, required resources, budget and timing
• Responsible for driving and delivering the project on-time & within budget and meeting the strategic business needs through effective project management methodology/principles
• Manage project scope, resources and stakeholders expectations/requirements
• Develop systematic approach, ongoing improvements and innovations to enhance performance in problem solving and project management
• Build coalitions among the various stakeholders and negotiate authority to move projects forward
• Proactively engage stakeholders throughout the project to gain their commitment, agreement and support on the proposed solutions, priority setting and implementation
• Consult and provide advice; facilitate discussion and resolve conflict; establish trust, build and use cross functional relationships to accomplish work objectives
• Advocate on behalf of stakeholders to negotiate with service provider (e.g. vendor and/or IT function) to ensure proper solutions meet the business strategic objectives
• Facilitate and lead all aspects of organizational changes for the assigned project responsibilities
• Communicate and/or present project timeline, risks, and overall status to the business functional leaders, senior managers, all appropriate stakeholders, and project team members
• Establish timely and proper communications to business sponsor and stakeholders that includes centralizing projects activities & information via dashboard or other mechanism
• Make decisions and take timely independent action in pursuit of priorities

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Main Purpose of the Position: Solve a wide range of challenging issues that impact multiple functions by managing change records in accordance to cGMP regulations and Genentech standards. Manage staff performing a variety of routine and complex change control activities to meet cGMP regulations and Genentech standards. Perform assigned tasks and manage performance and development of direct reports to ensure achievement of organizational and department goals objectives. 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 development. Manage and ensure the setting of realistic goals for staff and provide regularly scheduled feedback throughout the year. Ensure staff receives appropriate knowledge and skill development and growth opportunities. Set operational objectives for staff. Follow company policies and procedures. Help maintain a state of inspection readiness. Lead and participate in improvements to Quality operational policies, plans and procedures. Manage routine department activities and complex Quality initiatives. Ensure completion of activities and initiatives on time and within budget. 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 on relevant business processes. Be accountable for behaviors as described in Roche’s Core Competencies. Technical Duties/Responsibilities: Function as a Change Controller by assessing, reviewing, approving and closing change records. Ensure the management of lot release restrictions imposed by system, process, method and equipment changes. Author, edit, word process, and release controlled documents relating to Quality Systems. Provide training to new employees and internal customers on policies and procedures for the Change and Document Control systems. Facilitate and contribute to cross-functional change management forums. Recommend change control strategies that have minimal impact of validated systems and qualified equipment. Lead business process improvement and process redesign initiatives. Collaborate with departments to ensure that all review activities are executed efficiently and effectively. Support periodic audits and regulatory inspections. Develop and implement systems to ensure inspection readiness. Provide data for departmental performance metrics. Serve as a Quality representative on cross-functional and multi-site teams. May be required to support other Quality Systems & processes such as Document Management, CAPA, Product Complaints, Annual Product Reviews. Support internal and partner audits, and health authority inspections....

A Research Associate/Senior Research Associate position is available in the Protein Analytical Chemistry Department (within US Biologics Pharma Technical Development, PTDU).  The selected candidate will be responsible for developing, optimizing, and performing analytical methods to characterize recombinant protein therapeutics and antibody drug conjugates using techniques such as high-performance liquid chromatography (HPLC), mass spectrometry (MS), and capillary electrophoresis (CE).  The individual will maintain excellent documentation of all work including laboratory notebooks, test methods, or any other appropriate documents.  Additionally, the individual will be responsible for presenting results and experimental information to departmental colleagues, writing and reviewing internal reports, and representing the department on project teams consisting of members from all areas of process development.

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A Scientist position is available in Protein Analytical Chemistry (within US Biologics Pharma Technical Development, PTDU).  Responsibilities will include analytical characterization of recombinant proteins – primarily monoclonal antibodies and antibody-drug conjugates - using techniques such as high-performance liquid chromatography (HPLC), mass spectrometry (MS), and capillary electrophoresis (CE).  This will include development, optimization, and validation of analytical methods to be used for characterization and/or quality control of therapeutic protein candidates.  The individual will provide analytical support to different functional groups in PTDU and actively participate in project teams consisting of members from all areas of process development. The individual may be responsible for managing 1-2 research associates, depending on experience level....

Job Responsibilities:

Reporting to the manager of the Automation Systems group, the Systems Administrator is responsible for development and support of IT infrastructure and vendor application software associated with mission-critical automation systems, including the Building Automation System (BAS), Utilities Control System (UCS), Programmable Logic Controllers (PLCs), and Vendor Supplied Controllers (VSCs). Specific responsibilities will include:

• Perform GMP maintenance activities on automation systems, including monitoring, physical and logical security, backups, and change control
• Respond to system issues (including 24x7 on-call support); Troubleshoot and remediate issues
• Complete discrepancy, investigation and CAPA records as required
• Install operating system and vendor software patches and upgrades; Design and implement hardware upgrades, system expansions and enhancements
• Support site and network projects that involve system changes
• Perform periodic reviews and revalidations according to quality standards and validation protocols
• Assess and manage risks associated with system operation and use, and design and implement improvements
• Support site audits and inspections, and implement corrections as needed
• Maintain system documentation and life cycle support strategies
• Manage vendor support contracts to ensure delivery of products and services, and process renewals to ensure continuous coverage

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