• Focuses on process optimization and continuous improvement of existing Identity & Access Management processes and tools
• Follows established processes and standards in the execution of daily duties and job function

• Develops the Identity and Access Management services
• Promotes the Identity and Access Management services with all customers
• Supports the integration process of new or updated components by following established standards and providing the expected deliverables for handing over the service to operational teams and customers.

• Supports the integration of registration processes within the company’s identity management solution with focus on improving the operational environment, processes and procedures including data migration activities
• Follows appropriate SOPs and instructions required for the integration of registration services

• Manages the configuration and master data by assessing and specifying the possible need of data quality improvements
• Applies change management processes while managing the Identity & Access Management process integration
• Support the integration of business processes and applications by leveraging the Identity and Access Management infrastructure, tools and directories and following project management best practice.

• Manages the analysis, design and handover of access registration processes to the operational teams
• Ensures proper documentation and training material regarding registration processes is in place and kept up-to-date
• Manages the identity and access management processes to meet OLAs/SLAs by adhering to regulatory and qualitative requirements
• Increase process efficiency and cost effectiveness while providing identity and access management services
• Manage the integration of registration processes with focus on improving the operational environment, processes and procedures
• Manages and maintains the registration process portfolio
• Monitors and verifies the effectiveness of registration processes through established KPI and trend analysis
• Contributes to audit processes
• Based on business needs, identifies and proposes innovative, integrated, economically viable solutions
• Integrate identity and access management processes by meeting SLA requirements
• Supports that all solutions, documentation and procedures are implemented and maintained in a fully qualified and current state as applicable
• Registration processes are clearly communicated and trained
• Continuously strives for increase the skill level and expertise in the corresponding area
• Keeps abreast of business needs by maintaining close relationship to service management and other support services teams.
• Ensures compliance to Roche and Informatics Standards for technology, monitoring and support tools, SOPs and policies
• Ensures that documentation is current and accurate, SOP’s are understood and adhered to and platforms operate in highly secure and qualified environments in compliance with Audit, Regulatory and Validation requirements
• Ensures SLA requirements are understood and the required processes are implemented and managed to support compliance
• Provides shared platform support services as agreed (SLA or other) with the SM functions and other service consumers
• Provides input to support service levels and costs
• Fosters a working environment that encourages team members to fully contribute to achieve Roche’s goals
• Actively provides feedback to customer and team seeking for process improvements and efficiency gains
• manages the different integration projects within the portfolio to integrate new/existing IM applications into the service
• ensure standardization and globalization of application registration services by improving the operational environment, processes and procedures
• interface with the corresponding Engineering team if new features/interfaces are required
• ensure proper testing of application registration integration
• handover of new productive application registration processes to the operational team(s)
• create metrics/key performance indicators and develop/apply ...

This is an exciting opportunity within the Drug Substance Global Biologics Manufacturing Sciences and Technology (DS GBMSAT) department in the Pharma Technical Development organization.  GBMSAT provides technical leadership to develop solutions in support of commercial manufacturing across the internal and external Roche network.  GBMSAT plays a critical role in enabling the network concept for the MSAT network across Roche.   Additionally, GBMSAT provides technical leadership for technology transfers to contract manufacturing organizations.

• 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

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.

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

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 

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.

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.
  

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.

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

• Acts as lead of market planning team and primary contact for Market Planning projects and customers
• Supports strategic decision making across assigned areas/responsibilities; helping internal partners/stakeholders to maximize their commercial success
• Proactively evaluates/assesses the relevant market landscape, monitoring changes in market dynamics, competition, clinician and patient practices and needs, as well as other related factors
• Acts as a thought partner and consultant to assigned teams, functions and other relevant partners/stakeholders
• Partners with brand directors and other stakeholders to review and contribute to lifecycle, brand and tactical plans and provide supportive insights to help further inform, shape and influence business strategies and plans
• Provides long-range business plan forecasts for assigned brands
• Where appropriate, may partner with others, to review and integrate product- and market-specific assessments, analyses and the like into portfolio-wide (across all Genentech therapeutic areas and/or beyond) assessments for executive level reviews and decision-making
• Where assigned, helps internal partners/stakeholder to identify and set key performance metrics for assigned brands
• Employs a wide range of market analysis efforts and techniques, including penetration assessments, market share analyses, product concept testing, etc.
• Provides the continuous, in-depth cumulative perspective on the relevant market(s) and brand(s)
• Acts as the expert on the customer landscape, providing in-depth information and insights into customer practices and needs. As such, also possesses and applies in-depth product and therapeutic area knowledge
• Uses his/her understanding of the "broader market" to link insights and recommendations to wider strategic issues, challenges and/or opportunities:
• Synthesizes relevant analyses and prior research findings to develop a cumulative perspective of the relevant market(s) and associated factors; translates such into clear and meaningful implications for communication and review by internal partners and other stakeholders
• Recommends research/analysis methods and matches these to project objectives; understanding potential and/or limitations of various sources and methodologies
• Draws substantive conclusions from results; identifying implications, challenges or other opportunities and delineating clear next steps
• Develops a "command" of data/info sources and a sensitivity to biases
• Performs accurate analyses and thinks creatively about different ways to analyze data and information
• Defines questions and required data; appropriately comprehends quantitative methods and analysis techniques
• Identifies themes across projects and information sources; performing appropriate, aligned and integrated "meta-analyses"
• Where assigned, tracks key performance metrics for assigned brands
• Where assigned, creates, validates and refines forecasts for in-line products, new indications and new market opportunities. Presents updates on revenue information to senior management
• Where applicable, hires, develops and oversees the work of direct reports
• Complies with all laws, regulations and policies that govern the conduct of Genentech activities

MSDs are generally expected to perform their responsibilities with limited guidance from Medical Directors and/or other relevant internal partners and stakeholders:

·         Implement the medical affairs plan for the assigned drug(s) /indication(s), working with Medical Directors, mainly on PhIV clinical programs and their publication plans

·         Collaborates with Commercial and provides scientific input for the development and review promotional materials, documents and presentations developed for the assigned drugs and/or indications (signing off of any promotional material remains the responsibility of the Medical Director of the assigned drugs and/or indications)

·         Support his/her manager, as and when requested, in developing relevant parts of the medical affairs tactical plans, and/or completing other special projects such as preparation and review of training materials for field forces

·         Demonstrate ever-increasing competence in implementations of all aspects of medical plans

·         Competently and collaboratively interact with a host of internal and external partners and stakeholders

·         Consistently complete all assigned responsibilities on-time and on-target.

·         Develop and cultivate important relationships with internal and external partners and stakeholders. Includes investigators, thought leaders and KOLs (key opinion leaders)

·         Stay informed and abreast of the external landscape as it relates to assigned drugs and/or indications and the associated therapeutic area(s)

JOB DESCRIPTION - PRIMARY DUTIES AND RESPONSIBILITIES:

1. Clinical Trials & Programs 

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 GNE Medical Affairs, 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

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Purpose

In partnership with senior leadership, responsible for strategic direction and execution of medical communication plans for marketed products, pipeline molecules, and therapeutic area support. Oversight for MC scientist teams. Ensures product specialist resources are positioned to support current and future company needs. Accountable for the long-range financial planning and resource management for med comm product support.  Liaison responsible for directing and influencing corporate groups to achieve shared goals and objectives.

Job Description:

• Oversight for daily operations of the MC scientist teams, including responding to unsolicited requests, creation and maintenance of document response library, support for product launches, internal team support, and responding to label changes

• Provide oversight and leadership to the management team including strategic planning and tactics aligned with corporate and product priorities, champion department goals, and brand planning

• Year over year finance and resource budget planning as well as future resource forecasting for therapeutic area

• Accountability for representing MC at multidisciplinary senior-level cross functional committees including: Label committee (LC), reprint dissemination committee (RDC), healthcare compliance committee (HCC), patient communications committee (PCC), medical communications leadership team, and other committees where relevant; safety sub-teams (SST), promotional review committees (PRCs), Medical teams, major scientific meeting taskforce teams

• Career development of future leadership and succession planning for manager teams. Empower his/her staff to make sound decisions, and delegate as appropriate

• Develop and maintain collaborations with multiple corporate partners including Roche global, Novartis, Merk-Serono, Abbott, Biogen-Idec, and OSI pharmaceuticals

• Ensuring effective and efficient cross-product and cross-activity support via senior leadership collaborations

• Maintain awareness of the present state of business and needs by maintaining relationships with all relevant areas within and external to the Medical Affairs Organization

• Interacts and represents MC department with internal customers including but not limited to: Sales, Marketing, Clinical Operations, Clinical Science, Regulatory, Legal, and Safety.  Frequently represents MC outside of department  

All candidates are encouraged to apply, however a preferred candidate has been identified.

The ideal candidate must have demonstrated the ability to handle confidential, complex and sensitive information, and the ability to establish administrative processes and procedures to assist the group with projects and tasks.  Candidate will provide accurate and effective administrative support for Managers within the group and coordinate administrative duties with other Administrative Professionals to provide seamless support for the group.

*Manage multiple schedules with heavy calendaring of complete meetings.  Arrange, coordinate and support meetings, events and activities both on and off-site.

*Identify and anticipate needs of the group and plan work activities accordingly.  Look for areas of activity overlap with co-workers and leverage resources to maximize time, resources and dissemination of information.

*Generate, disseminate and maintain documents and information.  Develop, implement and evaluate department work processes and procedures.  Manage deadlines related to business planning as well as special projects.

*Collaborate with Admin team to support complex projects and deadlines.

*Understand and troubleshoot from a broader perspective and anticipate the impact of office admin problems and solutions on the other areas.

* Understanding and experience with approval processes for vendor contracts, ideally within GNE, is highly desirable. A large fraction of the workload for this position will be administering contracts for HEOR research partners.

General office responsibilities include but not limited to:

 *Schedule and coordinate staff onsite/offsite meetings, assist with special projects, schedule travel for staff, process payment and expense reports, plan, schedule and coordinate WebEx’s and teleconferences, maintain files, order department office supplies, order catering and other supplies for a variety of meetings and events, fully utilize MAC and software applications.  Exercise independent judgment and discretion of sensitive/confidential information.

QC Associate I (N5):

This is an 18 Month Term position on the weekend shift.

Main Purpose of the Position:     Perform analytical, biochemical, and/or biological testing; data review; and/or related activities that support QC operations. 

Job Duties/Responsibilities:

• Perform a broad variety of basic and moderately complex tests with documentation according to GMP Review data and assess against established acceptance criteria and peer generated data for basic methods.
• Prepare data tables and graphs
• Identify discrepancies andparticipate in quality investigations as needed.
• Receive and provide basic training
• Participate in assay transfer and assay validation.
• Perform testing for 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.
• Meets scheduled performance of 95% on time.
• Perform other duties as requested by managers to support Quality activities.
• Works under general supervision.
• Manager provides work priorities, timelines and resources
• Instructions given on new lines of work or special assignments.
• Progress on work assignments is generally reviewed on a regular basis.

Capabilities Identified for Success:

• Accountability
• Attention to Detail
• Communication
• Organization and Prioritization
• Policies, Process, Procedures
• Teamwork

SHE requirements

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…