This position will support cell culture process development projects in the Late Stage Cell Culture Department, including characterization and validation studies. The candidate will be responsible for designing and executing lab bench-scale experiments (bioreactors, shake flasks, etc.), coordinating and supporting pilot plant experiments, analyzing data, and summarizing the results in technical documents and oral presentations. He/she will also be expected to contribute to the identification and evaluation of cell culture technology development projects and may represent cell culture on multidisciplinary project teams and task forces. He/she will be required to author internal technical, characterization and validation documents as well as deliver high quality scientific presentations to the lab group, department and externally.

...

Summary:

Team Overview:

The HTO Planning and Scheduling team partners with the business and other functional groups at HTO to deliver business results focused on exceeding customer expectations and optimization of the Schedule, Make, Assess and Release business processes; improving reliability and enabling exceptional operational performance.

Position Overview:

The Sr Planner Scheduler is responsible for managing the daily plant schedule for production and non-production activities to support budgeted production and site priorities at Genentech’s aseptic fill and finish facility in Hillsboro, OR.  He/She will also play a critical role in developing project timelines and achieving project milestones in support product transfer activities in drug product aseptic filling operations, product inspection and commercial packaging operations.   The successful candidate must effectively lead a daily team meeting to coordinate and prioritize plant activities within existing resources, effectively manage due dates, and proactively mitigate issues impacting operations.  This individual must also be able to assist in the development, implementation and continuous improvement of related business processes.   

...

Create and edit controlled documents at all levels of complexity consistent with current formats and department style guides using the DocLink Electronic Document Management System (EDMS). Ensures document changes have been approved within the Trackwise Technical Change Management System.  Ensure new, revised, retried, or temporary documents are in accordance with Quality Requirements and Global Standard & Processes. Ensure requirements for making document changes are met. Verify the changes being made to the document have been authorized in the change record.  Initiate a document change workflow to execute a document change. Edit the document according to the change record.  Perform final review of the document for consistency and completeness.  Assign the appropriate document approvers. Collaborate with the Change Owner and Change Controller to resolve issues when a document is rejected. Ensure all document approval signatures have been obtained prior to releasing the document. Ensure all gating, training, and change deployment requirements outlined in the change record are considered when releasing the document and assign an effective date for the document. Maintain a master copy of all controlled documents released locally in a secure location.  Support the Controlled Document Manuals (CDMs) and the Document Audit Reporting program.  Evaluate and prioritize assigned document workload to meet internal productivity targets.  Partner with other change control groups to coordinate changes with cross site impact. Represent department on interdepartmental project teams. Track and communicate the status of document changes and projects. Enforce document and change control policies and procedures. Participate in document change control process improvement initiatives.  Train new hires and internal customers, as appropriate.  Support generating and presenting data for agency and third party audits.

Follow company policies and procedures. Maintain a state of inspection readiness.

Provide input to the development of personal performance goals and departmental objectives.

Collaborate with Management to establish and meet targets and timelines. Independently manage competing priorities with limited instruction. Serve as a Quality representative on cross-functional and multi-site teams. Identify and recommend solutions to potential procedure, process and system gaps. Provide assistance to customers in support of departmental functions. Participate in the design and implementation of department and cross-functional initiatives. Apply basic theory and technical principles to address moderately complex problems.

Troubleshoot and initiate 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. Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions. Be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies. Perform any other tasks as requested by Management to support Quality oversight activities.

...

Responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment, and maintain areas in high state of inspection preparedness.  Operates production equipment for cell culture or purification that may include culture growth, process monitoring, sampling, harvesting, purification, formulation, freeze thaw and transfer.  Performs media/buffer solution preparation operations.  Maintains records and clean room environment to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP).  Responsible for being proficient in two or more functional areas and applies expert knowledge of mechanical, scientific principles, processes and biopharmaceutical processing equipment.

 

Job Responsibilities

Essential

• Provide coaching and training on best practices and compliance to SOPs.

• Prepare solutions for the production process.

• Participate in continuous operational improvement.

• Provide reports to management summarizing goal unit attainment.

• Work with coworkers and supervisor to effectively troubleshoot equipment and process issues.

• Understands the theory, concepts, and regulations behind biopharm technology and processes. 

• A strong knowledge of at least one manufacturing department with an understanding of process impact of other areas.

• Anticipates potential problems and takes preventative action.

• Requires judgment to know when it is necessary to consult with supervisor and/or support groups. 

• Understands how own actions impact others and uses this information in decision-making.

• 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 equipment and process issues.

• 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.

Supplementary Responsibilities

• Operate fermenters, centrifuges, other harvest 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 operating cleaning, set up, and maintaining 20L batch reefed fermenters; inoculating and maintaining spinner seed cultures using aseptic techniques, maintaining cell banks; and performing general seed lab operations.

• Perform CIP and SIP.

...

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

...

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

...

  The Product Quality – Biologics group is part of IMP QA.  The department is responsible for the product quality for biologics and antibody-drug-conjugates in the global Roche network throughout the development lifecycle to commercialization.  As a member of the IMP Product Quality group, the Sr. Quality Product Leader serves as the single point of contact on the technical development teams and is accountable for driving the quality activities for the teams.  This position must effectively communicate timelines and issues to Quality to ensure successful manufacturing, product testing/release and regulatory filings.    Additionally the position must partner with other organizations throughout Roche Global Pharma Technical Operations, including but not limited to: QA Operations, Commercial Quality, External Quality, Pharma Technical Development (PTD), and Regulatory (PTR).  This position will primarily support project activities during late stage development and the process handover from development to commercial as part of new product commercialization.

Responsibilities
•Participate in regular technical development team meetings and provide clear and timely feedback to the teams.•Communicate timelines and issues to all relevant Quality departments in a timely manner.
•Engage and collaborate with partner groups (e.g., within and outside Quality, external partners, etc.) and across global sites in the Roche network to ensure production, testing and release, and regulatory submission timelines are achieved without compromising product quality. 
•Proactively work with technical development teams, commercial counterparts, and senior management to identify and escalate project quality risks with the goal of delivering a robust process appropriate for commercial filing acceptable to Health Authorities and provides reliable products after launch
•Provide high level oversight of PC/PV, method validation and transfer activities during commercial filing preparation, and ensure timely escalation of timeline bottlenecks to senior management
•Lead Quality investigations, including developing proposals for resolution of product-impacting Quality issues and presentation for endorsement to Quality Review Boards, and oversight of outcome of appropriate CAPA’s associated with product-impacting investigations.

...

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

...

This position may be filled at an Associate Field Reimbursement Manager or Field Reimbursement Manager level.
 
The Territory for this position will cover New York City and New Jersey North. 

Candidate can live within any of  these territories, but would prefer New York City.

 
The Retinal Field Reimbursement Manager (RFRM) helps to minimize reimbursement barriers for patients and providers and, therefore, helps to optimize access to Genentech products in the assigned therapeutic area.  The FRM works closely with internal partners, supporting targeted accounts, and helping resolve reimbursement issues or concerns. They also develop ethical and customer-oriented reimbursement tactics, and proactively communicate payer criteria/terms and practices, as these relate to reimbursement for the assigned GNE products.

• Works with internal partners to review franchise, managed care, and divisional field sales business plans and objectives
• Acts as a subject matter expert on the payer landscape relevant to the assigned Genentech therapeutic area(s)/product(s)
• Acts as a conduit between the Field and Home Office Genentech functions for all public and private payer policies and practices that impact patient access to Genentech products
• Assists Coverage & Reimbursement with individual case management needs
• Develops ethical and customer-oriented reimbursement tactics
• Trouble-shoots field account reimbursement issues, needs, concerns, or challenges
• Spends majority of time visiting customer accounts in the field
• Proactively communicates and explains Genentech-specific reimbursement programs, policies, procedures and resources
• Works with relevant state, institutional or other societies
• Complies with all laws, regulations and policies that govern the conduct of GNE activities
• Business travel, by air or car, is regularly required
• In addition to passing Genentechs background screening, the employee must submit to and pass additional background screening as required by some institutions and health facility sales accounts (additional screening requests may include but are not limited to background checks, immunization, TB, HIV, hepatitis, and drug screening)

"This position requires significant use of either a company provided or personal vehicle to perform the essential duties and responsibilities of the role.  As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business."

...

The Clinical Pharmacology Department at Genentech, Inc. is seeking a Ph.D. level Scientist who is driven to understand the clinical pharmacokinetics and pharmacodynamics of novel drug candidates in the areas of Oncology, Immunology and/or CNS . This individual will be responsible for the clinical pharmacology activities of delivering Small Molecules in clinical development. In addition to having responsibility for the Clinical Pharmacology strategy to ensure that appropriate dose, route, and schedule decisions are made using the state of the art modeling and simulation approaches. This will be accomplished by working in close partnership with Clinical Science, Clinical Operations, Regulatory, Biostatisticians and other functions which make up project teams. Other responsibilities will include planning and reviewing study designs, PK/PD data analysis and interpretation of analysis, as well as planning, preparation and implementation of clinical pharmacology sections, and organization of regulatory filings (worldwide). Clinical Pharmacologists at Genentech often present data at cross-functional teams, department meetings, conferences and regulatory global health authority meetings (worldwide). Additionally, this individual will also be directly involved in leading interdisciplinary sub project teams and representing the function at cross-functional project teams.

...

Accountable for end-to-end infrastructure and ensure thecomplete integration of the solutions into the operational landscape. SupportSolution owner with lifecycle management and Components.

This includes installation and upgrade throughmaintenance and operations to decommissioning.

1.2 PrimaryResponsibilities

• Provides technical Subject Matter Expertise input into solution design, optimization, change requests and problem resolution
• Participates in implementation of new projects and in changes of existing solutions and actively execute project related tasks and activities.
• Coordinates and manage installations, upgrades, changes and software integration including test design, execution and support
• Ensures the integrity of solutions and qualified state during their lifetime
• Coordinates and supports security patching and upgrades with the Solution Owners
• Ensures compliance with security SOPs/policies, and that adequate access rights are given to trained staff.
• Coordinates incident management activities with Solution Owners and the AE&O component Managers until final resolution and supervise re-active problem management process

• Identifies and analyzes potential areas for improvement of the solution (pro-active problem management), and Delivers continuous improvement of the solutions assigned.

• Represents the Delivery Organization into AE&O so that the business is represented in technology decisions, planning and participation.
• Ensures solution design and integration of the AE&O skill sets required to support the new solution
• Ensures re-use of existing AE&O solutions and components wherever possible to minimize the development of new solutions
• Ensures all new solutions are designed and developed in a cost efficient manner, delivering the appropriate level of service quality

• Ensures communication of AE&O initiatives, policies and important activities to appropriate Delivery Organization.

...

Market Planning Manager, Oncology - Global Product Strategy

Participate actively in global commercial planning efforts by providing objective, in-depth analyses on current and future markets, product performance, customers, and competitors. Additionally, identify critical business issues and opportunities for growth, collaborate with Genentech/Roche teams, and work to embed an external market point-of view into the strategic direction of the company.

This Global Market Planning Manager / International Business Analyst position is a global role based in South San Francisco. This individual will be a member of a global cross-functional team focusing on development of our pipeline products and will be required to travel domestically and internationally.

KEY ACCOUNTABILITIES:
*Proactively and continuously assess the relevant marketplace and its dynamics, customers and competitors to enable strategic decision making regarding brands and business operations.
*Business partner within assigned cross-functional teams: developing strategic insights and providing in-depth product and marketplace knowledge.
*Ensures alignment across internal partners, stakeholders, and senior management.
*Leads initiatives to facilitate growth and development of the Global Strategic Analytics team
*Responsible for new market and product opportunity assessments.
*Creates, manages, validates, and refines forecasts (product and market)
*Communicates revenue forecasts and assumptions to internal partners, stakeholders, and senior management.
*Develops and implements market research plans, in conjunction with cross-functional teams.
*Provides analytical input to the Disease Area Director during due diligence for in-license opportunities and liaises with partnering groups.
*Actively contributes to cross-functional or other project teams, helping the overall business evolve, improve & excel.
...

As a key member on project teams the Global Project Manager II (GPM II), Product Development-Project Excellence (PDP) is expected to actively contribute and challenge the definition and development of project strategy, and then help teams to effectively and efficiently deliver on the strategic objectives agreed with the relevant governance body. The GPM II partners with the team leader to anticipate, identify, manage and communicate project risks. GPMs achieve this by delivering high quality project management support and other high value services:

• Applies project management expertise
• Takes accountability for all project management aspects and works
  effectively and closely with the project leader / team leader (PL/TL)
• Enables generation of innovative, exploratory and/or confirmatory options through project management expertise
• Ensures consistency of project planning from exploratory through to confirmatory development and health authority submission
• Contributes to the functional excellence development of project management
• Provides project management expertise to Due Diligence

The Global Project Manager II is accountable for:

• The development, maintenance, pro-active tracking & management of a high quality, ambitious integrated project plan
• Closely and transparently manage the critical path of the project
• Effectively guides a due diligence team through the formation of a comprehensive drug development plan and budget
• Maintaining, tracking, reporting and understanding variances in the integrated project budget by working in close collaboration with functional contributors and finance
• Guiding and managing the team through the value chain processes ensuring effective and efficient team operation
• Excellent interpersonal skills, including clear, succinct and timely communication and proven ability to foster important relationships with customers and key stakeholders.
• The integrity and accuracy of project information to meet team, management and portfolio requirements.
• Partnering with the team leader in identifying, managing & communicating key project risks and leading risk management strategies

...

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

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

Work on projects related with these components

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

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

Participate in security hardening drills, audits, proof of concept

Work on user requests, incidents and problems

 

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

Problem Management

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

 

Incident Management

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

...

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

We are seeking a collaborative individual to contribute to a team that is responsible for generating recombinant proteins by transient transfection of mammalian cells. The candidate’s primary responsibility will be high throughput transient protein production to support research and development projects. The tasks will include those associated with coordinating and performing cell culture operations (i.e. set up, inoculate, monitor, harvest and clean fermentors) as well as experiment data recording, collection and analysis. He /she will display a strong focus on collaboration, attention to detail, proficiency with multi-tasking and analytical ability. The secondary responsibility of this candidate is to optimize our transient transfection process. This includes identifying and solving technical issues, performing process development experiments, and evaluating and implementing new technology/instrumentation based on scientific literature and industry trends.  The right candidate will have experience with supervisory or management responsibilities.

...

• Plan and execute stress, performance and functional Test on applications and systems using automation and manual Testing. 
• Maintain an understanding of leading tools and technologies for development of mission critical web, database and related applications. (HP Suite, Selenium, Segue, etc). 
• Lead the development of SQA Test Plans, Specifications and Project Scheduling. 
• Collaborate with other SQA Leads in the development of  QA/QCProcedures, Test Scripts, and SQA lab standards and tools requirements. 
• Identify opportunities for process improvements that streamline development activities while minimizing risk.
• Mentor other team members in testing processes & testing tools in order to execute Test Plans as required
• Manage onsite and offshore testers

...

Clinical Specialist - Lytics
Territory: Long Island, NY

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

The applicable therapeutic area / disease states are: Central Venous Catheter Management and Acute Ischemic Stroke

Reports to: Division Manager, Franchise Sales

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

NOTE:
This position requires significant use of either a company provided or personal vehicle to perform the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business.

...

An Associate Scientist position is available within the Late Stage Pharmaceutical Development Department.  The primary responsibility will be leading particle identification and analytical characterization efforts to support pharmaceutical development.   These activities include the development and implementation of novel analytical methods, physical-chemical characterization of particles including compositional analysis, and root cause analyses in support of product investigations. The candidate is expected to participate in cross-functional product development teams and work closely with other technical groups including analytical chemistry, protein purification, quality, and regulatory.  Further, the candidate is expected to develop scientific independence and exhibit creativity by identification and evaluation of new scientific opportunities that further the current state-of-the-art....

The job responsibility within the Biological Technologies group in Analytical Development and Quality Control, is to develop, qualify/validate, and troubleshoot biochemical/immunochemical and cell-based assays for clinical and to-be-marketed products.  The candidate will perform testing as needed in support of process development, stability, and lot release according to established test procedures..  Expectations will also include some routine lab maintenance, participate in writing SOPs, test procedures, and participate in training, performing testing, troubleshooting, and/or validation of immunological and cell-based potency methods.  Additional responsibilities may include presentation of data at internal meetings and participating in the evaluation of new equipment and technologies. ...