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453 jobs match your search criteria:
| Date | Job Title | Job Level | Location | |
|---|---|---|---|---|
| May 20, 2013 |
Clinical Specialist, Pegasys - NY Metro
Clinical Specialist |
Experienced | New York, New York | |
| May 29, 2013 |
Sr Engineer
Responsible for the administration and operation of the site’s programmable logic controllers (PLC) and provides instrumentation and control engineering expertise to the Engineering Group. Focus on providing operational support for existing facilities with respect to the instrumentation and control systems for process, utility and building systems. Provides operational support and interfaces with the Siemens Building Management and Emerson Delta V systems as needed. Job Responsibilities Essential Supplementary Responsibilities |
Experienced | Oceanside, California | |
| May 30, 2013 |
Finance Manager/ Senior Finance Manager (Product Operations)
The Position Senior Finance Manager/ Finance Manager commensurate with experience JOB DESCRIPTION: Position is dedicated to supporting the financial management of the Oceanside Product Operations, part of the Roche Biologics Operating Unit (OU). The position will report to the Site Finance Head for Oceanside and is part of the Pharma Technical Operations Finance group, which is charged with the financial stewardship of Genentech's Technical Operations organization. Beyond delivering on core job objectives, the position will have the opportunity to extend and lead other site and global network initiatives. MAJOR RESPONSIBILITIES: Responsible for the financial planning, analysis, and reporting activities of the Oceanside Drug Substance Manufacturing operations. Act as a key Finance business partner to the functional heads of the operations and quality organization. Develop strong business acumen and partner with the OU to help guide the business functions and support business and financial analysis. Planning and Analysis
Reporting
MAJOR SKILLS AND BEHAVIORS:
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Experienced | Oceanside, California | |
| May 21, 2013 |
Master Manufacturing Process Maintenance Mechanic
Conduct repetitive, predictive, condition based, reactive maintenance and troubleshooting of cGMP production equipment, clean utilities and plant utility systems. Assist with engineering and evaluation of existing and new equipment and processes. This is a Journeyman level position.
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Experienced | Oceanside, California | |
| May 8, 2013 |
Manager, Facilities
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Manager with Direct Reports | Oceanside, California | |
| May 15, 2013 |
Master Maintenance Mechanic, Utilities
Conduct repetitive, predictive, condition based, reactive maintenance and troubleshooting of cGMP production equipment, clean utilities and plant utility systems. Assist with engineering and evaluation of existing and new equipment and processes. This is a Journeyman level position.
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Experienced | Oceanside, California | |
| May 10, 2013 |
Technical Manager, Validation- Term Position
This is a term position for approximately 9 months Responsible for implementing and maintaining the validated state of automated systems at Genentech’s Oceanside Facility. Expected to be knowledgeable of and work within GMP regulations. Requires protocol generation, execution, data analysis, troubleshooting skills, deviation investigation and protocol report closure for the site. Responsible for validation contractor oversight, demonstrating leadership skills and modeling Genentech values and core competencies while working closely with Engineering, MSAT, Quality Assurance and Manufacturing. This position requires strong communication and collaboration skills, the ability to work within teams, facilitate meetings and lead teams. Job Responsibilities Essential Manage and track the Validation program and assigned validation projects for automated systems and ensure target timelines are met and/or issues are communicated / escalated effectively and consistently. |
Experienced | Oceanside, California | |
| May 16, 2013 |
Clinical Specialist - Central Illinois including Springfield, Peoria, Quad Cities
Clinical Specialist
Territory: Central Illinois (including Springfield, Peoria, Quad Cities) The Clinical Specialist, Franchise Sales manages and develops long-term relationships with physicians and other customers for the customer accounts in the assigned territory in the Hospital/Critical Care setting. As such, Clinical Specialists represent the assigned GNE brand(s) and their approved indications; helping external customers such as physicians, nurses, etc. learn about the benefits of the assigned GNE brand(s) in relation to the applicable therapeutic area/disease state. The applicable therapeutic area / disease states are: Acute Ischemic Stroke¿and Central Venous Catheter Management and Reports to: Division Manager, Franchise Sales¿¿ Example Duties and Responsibilities: • Responsible for meeting or exceeding assigned sales targets • Develops robust territory business plans • Develops strong and long-term relationships with customers in all assigned accounts • Presents the assigned GNE brands in a professional, compliant, ethical and effective manner; helping external customers understand the benefits and use of GNE brands • Monitors operating costs and compliance with territory budget • Complies with all laws, regulations and policies that govern the conduct of GNE activities • Business travel, by air or car, is regularly required NOTE: This position requires significant use of either a company provided or personal vehicle to perform the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business. ... |
Experienced | Peoria, Illinois | |
| May 16, 2013 |
HCV Clinical Specialist - Richmond, VA
HCV Clinical Specialist
Territory: Richmond, VA and Virginia Beach, VA areas The HCV Clinical Specialist, Pegasys Sales manages and develops long-term relationships with physicians and other customers for the customer accounts in the assigned territory. As such, Clinical Specialists represent the assigned GNE brand(s) and their approved indications; helping external customers such as physicians, nurses, etc. learn about the benefits of the assigned GNE brand(s) in relation to the applicable therapeutic area/disease state. Reports to: Division Manager, Pegasys Sales Example Duties and Responsibilities: • Responsible for meeting or exceeding assigned sales targets • Develops robust territory business plans • Develops strong and long-term relationships with customers in all assigned accounts • Presents the assigned GNE brands in a professional, compliant, ethical and effective manner; helping external customers understand the benefits and use of GNE brands • Monitors operating costs and compliance with territory budget • Complies with all laws, regulations and policies that govern the conduct of GNE activities. ... |
Experienced | Richmond, Virginia | |
| May 31, 2013 |
Clinical Specialist - Nephrology, San Francisco
Franchise: Rheumatology Territory: San Francisco The Clinical Specialist, Nephrology Sales manages and develops long-term relationships with physicians and other customers for the customer accounts in the assigned territory. As such, Clinical Specialists represent the assigned GNE brand(s) and their approved indications; helping external customers such as physicians, nurses, etc. learn about the benefits of the assigned GNE brand(s) in relation to the applicable therapeutic area/disease state. Duties and Responsibilities:
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. ... |
Experienced | San Francisco, California | |
| May 21, 2013 |
PTR Regional Hub Sr. Regulatory Associate / Regulatory Manager
PTR Regional Hub Sr. Regulatory Associate (E3) / PTR Regional Hub Regulatory Manager (E4)1 Department: Pharma Technical Regulatory (PTR) Job Family / Category: PTR Regional Hubs
Purpose
This position will be responsible for execution and management of regional life-cycle submissions for all Roche products as well as new product registrations by focusing on local needs of Affiliate Drug Regulatory Affairs (DRA) teams to ensure right first-time submissions to Health Authorities.
Responsibilities:
* The incumbent will be the primary technical regulatory (CMC) point of contact for the Affiliate DRAs and as such he/she will work closely with them and the regional Supply Chain teams as well as with the PTR product managers and the PTR network. * In coordination with global PTR Technical Regulatory Leaders (TRL), execute regulatory strategy for lifecycle submissions in Asia Pacific markets associated to management of CMC changes originating at manufacturing sites or affiliates toward maximizing efficiency, quality and rate of submission approvals by Health Authorities. * Coordinate strategic planning with Regional Supply Chain and Affiliates DRA for change management alignment and early visibility/communication/planning of changes impacting markets in the region. * Assemble lifecycle submissions for markets under responsibility to guarantee right first time submissions and coordinate/manage with affiliates for timely and effective submission of changes to the Health Authorities. * Act as subject matter expert in regulatory requirements for post approval submissions and maintain the regulatory intelligence repository for regional markets under responsibility. * Ensure timely update of the CMC change management electronic systems with the regulatory information submitted/approved externally by a Health Authority or internally by the appropriate functional area. * Upon request, support Affiliate DRA with interactions with regulatory authorities to facilitate the prompt review and approval of submissions (CMC content Subject Matter Expert). * Manage timely responses to Health Authority questions resulting from lifecycle submissions in regional markets under responsibility. * Manage tracking of commitments with a Health Authority as result of license/dossier approval and ensure commitments due dates are met. * The candidate may be required to travel to other Roche sites on a periodic basis. ... |
Experienced | Singapore, Singapore | |
| May 21, 2013 |
Associate Director, Regulatory (PTR) APAC Regional Hub - Singapore
PTR APAC Regional Hub Associate Director
Purpose
This position will lead a PTR team regionally located in Singapore responsible for Asia Pacific regional management of life-cycle submissions for all Roche products as well as new product registrations by focusing on local needs of Affiliate Drug Regulatory Affairs (DRA) teams to ensure right first-time submissions to Health Authorities.
Responsibilities:
* Lead team of professionals responsible for regional/local management of lifecycle submissions in Asia Pacific markets, including: market applications (NDA/BLA), post-approval submissions/variations, renewals and annual reports, for pharmaceutical small molecules and biological products. * In coordination with global PTR Technical Regulatory Leaders, lead submission strategy for execution of lifecycle submissions in Asia Pacific markets associated to management of CMC changes originating at manufacturing sites or affiliates toward maximizing efficiency, quality and rate of submission approvals by Health Authorities. * Liaise with Regional Supply Chain management team and Affiliates DRA for strategic planning and influencing change management alignment and early visibility/communication/ planning of changes impacting markets in the region. * Lead assembly of lifecycle submissions for markets under responsibility to guarantee right first time submissions and coordinate with affiliates for timely and effective submission of changes to the Health Authorities. * Act as subject matter expert in regulatory requirements for post approval submissions and assure maintenance of regulatory intelligence repository for regional markets under responsibility. * Ensure that the CMC change management electronic systems are timely updated and maintained in alignment with the regulatory information submitted/approved externally by a Health Authority or internally by the appropriate functional area. * In coordination with Affiliates DRA, act as direct liaison with regulatory authorities to facilitate the prompt review and approval of submissions (CMC content Subject Matter Expert). Manage timely responses to Health Authority questions resulting from lifecycle submissions in regional markets under responsibility. * Manage tracking of commitments with a Health Authority as result of license/dossier approval and ensure commitments due dates are met. * Manage work activities for team members supporting the Asia Pacific region. * The candidate may be required to travel to other Roche sites on a periodic basis. ... |
Executive (Director/VP/SVP) | Singapore, Singapore | |
| May 21, 2013 |
PTR Regional Hub Sr. Regulatory Associate / Regulatory Manager
PTR Regional Hub Sr. Regulatory Associate (E3) / PTR Regional Hub Regulatory Manager (E4)1
Department: Pharma Technical Regulatory (PTR) Job Family / Category: PTR Regional Hubs
Purpose
This position will be responsible for execution and management of regional life-cycle submissions for all Roche products as well as new product registrations by focusing on local needs of Affiliate Drug Regulatory Affairs (DRA) teams to ensure right first-time submissions to Health Authorities.
Responsibilities:
* The incumbent will be the primary technical regulatory (CMC) point of contact for the Affiliate DRAs and as such he/she will work closely with them and the regional Supply Chain teams as well as with the PTR product managers and the PTR network. * In coordination with global PTR Technical Regulatory Leaders (TRL), execute regulatory strategy for lifecycle submissions in Asia Pacific markets associated to management of CMC changes originating at manufacturing sites or affiliates toward maximizing efficiency, quality and rate of submission approvals by Health Authorities. * Coordinate strategic planning with Regional Supply Chain and Affiliates DRA for change management alignment and early visibility/communication/planning of changes impacting markets in the region. * Assemble lifecycle submissions for markets under responsibility to guarantee right first time submissions and coordinate/manage with affiliates for timely and effective submission of changes to the Health Authorities. * Act as subject matter expert in regulatory requirements for post approval submissions and maintain the regulatory intelligence repository for regional markets under responsibility. * Ensure timely update of the CMC change management electronic systems with the regulatory information submitted/approved externally by a Health Authority or internally by the appropriate functional area. * Upon request, support Affiliate DRA with interactions with regulatory authorities to facilitate the prompt review and approval of submissions (CMC content Subject Matter Expert). * Manage timely responses to Health Authority questions resulting from lifecycle submissions in regional markets under responsibility. * Manage tracking of commitments with a Health Authority as result of license/dossier approval and ensure commitments due dates are met. * The candidate may be required to travel to other Roche sites on a periodic basis. ... |
Experienced | Singapore, Singapore | |
| May 21, 2013 |
Regional Hub Sr. Regulatory Associate / Regulatory Manager - Singapore
Department: Pharma Technical Regulatory (PTR)
Job Family / Category: PTR Regional Hubs
Position: PTR Regional Hub Sr. Regulatory Associate PTR Regional Hub Regulatory Manager
Location: Tuas, Singapore
Purpose
This position will be responsible for execution and management of regional life-cycle submissions for all Roche products as well as new product registrations by focusing on local needs of Affiliate Drug Regulatory Affairs (DRA) teams to ensure right first-time submissions to Health Authorities.
Responsibilities:
* The incumbent will be the primary technical regulatory (CMC) point of contact for the Affiliate DRAs and as such he/she will work closely with them and the regional Supply Chain teams as well as with the PTR product managers and the PTR network. * In coordination with global PTR Technical Regulatory Leaders (TRL), execute regulatory strategy for lifecycle submissions in Asia Pacific markets associated to management of CMC changes originating at manufacturing sites or affiliates toward maximizing efficiency, quality and rate of submission approvals by Health Authorities. * Coordinate strategic planning with Regional Supply Chain and Affiliates DRA for change management alignment and early visibility/communication/planning of changes impacting markets in the region. * Assemble lifecycle submissions for markets under responsibility to guarantee right first time submissions and coordinate/manage with affiliates for timely and effective submission of changes to the Health Authorities. * Act as subject matter expert in regulatory requirements for post approval submissions and maintain the regulatory intelligence repository for regional markets under responsibility. * Ensure timely update of the CMC change management electronic systems with the regulatory information submitted/approved externally by a Health Authority or internally by the appropriate functional area. * Upon request, support Affiliate DRA with interactions with regulatory authorities to facilitate the prompt review and approval of submissions (CMC content Subject Matter Expert). * Manage timely responses to Health Authority questions resulting from lifecycle submissions in regional markets under responsibility. * Manage tracking of commitments with a Health Authority as result of license/dossier approval and ensure commitments due dates are met. * The candidate may be required to travel to other Roche sites on a periodic basis. ... |
Experienced | Singapore, Singapore | |
| Feb 14, 2013 |
Senior Audit & Inspection Management
IT Quality is a trusted partner for customers to ensure and improve the overall quality of IT systems throughout their lifecycle with a focus on compliance with regulatory, legal and finance requirements. We are looking for a customer-focused, highly collaborative individual responsible hosting and supporting audits and inspections and ensuring audit corrective actions are tracked and closed in a timely manner. The position is responsible for effective planning and management of audits and inspections with business quality and audit groups. Further responsibilities include:
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Experienced | South San Francisco, California | |
| Dec 10, 2012 |
QC Scientist/Pharmaceutical Specialist II
The QC Pharmaceutical Specialist will be a member of the Method Transfer, External QC, and Method Monitoring group, which is part of ROCHE/GENENTECH’s Global Method Management and Technology (Global MMTech), the department responsible for the life cycle management of all commercial methods and control systems and innovation within Commercial Biologics Quality. Job Responsibilities: |
Experienced | South San Francisco, California | |
| Oct 18, 2012 |
Senior Pharmaceutical Computer System Validation Specialist
Job Duties/Responsibilities
|
Experienced | South San Francisco, California | |
| Oct 18, 2012 |
Sr Finance Manager
Senior Finance Manager - Commercial Finance
COMPETENCIES
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Experienced | South San Francisco, California | |
| Aug 31, 2012 |
Sr. Manager, DBA Admin
The senior DBA manager leads and manages a staff of Database Administrator (DBA) professionals for Genentech database environment that includes Oracle and SQL Server. The individual will work with other global IT team leaders to translate the organization's IT strategy into specific database roadmaps and deliverables, measures the effectiveness of the delivery model, and track progress against plan and operational Service Level Agreements (SLA). The individual will provide management and implementation of strategic initiatives for the enterprise databases services in the charge toward efficiency and optimization. In addition, the individual is responsible for developing processes and procedures for overall IT Operations, upgrading and maintaining IT processes,production controls, capacity planning, and system backups and recovery. Key Strategic Objectives * Lead the organization through organizational change, technology transformation, and sustained growth while exhibiting excellent judgment on how to prioritize between operational excellence and financial prudence * Drive successful creation of a strong team dynamic in a collaborated and risk-taking culture. Translate the organization's strategy into tactical execution plans replete with key performance measures and monitor the results on regular basis * Improve Genentech's return on invested capital by having a systematic capacity planning process to maximize the utilization of assets and increase the velocity of infrastructure investment in virtualization and cloud computing. * Build and develop future leaders of the organizations while advancing Genentech's image as one of the best places to work in America. Responsibilities: • The right candidate for this position is well organized, and an exceptional communicator with his/her team, peers, executive management, and the company.• This person must be able to lead and manage change. The individual will live by metrics, staying ahead of the tactical while also deeply understanding the needs of various business teams to appropriately plan for growth and change. • Demonstrated ability to lead and energize multidisciplinary teams with gifted communication and interpersonal skills. • Demonstrated analytical, problem-solving and conceptual skills. • Ability to analyze project needs and determine resources needed to meet objectives. • Demonstrated negotiation skills with vendors or management and ability to influence management regarding matters of significance to the organization. • The successful candidate must be able to establish credibility very quickly in organization with shifting priorities. • The individual must be a strong leader who can prioritize well, communicate clearly and compellingly and who understands how to drive a high level of focus and excellence with a strong, talented, opinionated team. • The individual will have a technical aptitude particularly in the database domain and be credible as leader in a technical organization. • The individual will be able to articulate with full clarity the aspiration of his teams, and achieve results through influence and leadership rather than direct authority... |
Manager with Direct Reports | South San Francisco, California | |
| May 29, 2013 |
Forecasting Manager/Sr. Manager
The Forecasting Manager/Senior Manager will support Brand Teams and
Commercial Management decision-making by delivering revenue forecasts on a regular basis throughout the year as well as in response to ad- hoc customer requests. This individual will play an integral role with responsibility for ensuring that all forecasts are based on reliable information and rigorous analyses, including uncertainty analyses, and that short-term and long-term forecasts are aligned. He/she will partner with different functional groups (Marketing, Customer Operations, Finance, Supply Chain, and other groups within Market Analysis & Strategy) to deliver analyses that enable a thorough understanding of brand performance and expectations. He/she will work with multiple Excel-based models as well as other quantitative and qualitative resources to perform scenario analyses. In addition, he/she is expected to present findings to key stakeholders, provide recommendations, and implement approved recommendations. ... |
Experienced | South San Francisco, California |
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