Job Search
442 jobs match your search criteria:
| Date | Job Title | Job Level | Location | |
|---|---|---|---|---|
| May 21, 2013 |
Regulatory Advisor, CMC Small Molecule, Marketed Products
The Regulatory Advisor will be responsible for developing global regulatory strategy, writing high quality dossier and leading teams for assigned projects to obtain timely approvals of Roche applications. The Roche Pharma Technical Regulatory leadership team is composed of seasoned technical experts whose focus is to collaborate with Roche Scientists and International Health Authorities to drive development of innovative regulatory policy, and ensure the approval of Roche products developed using novel and efficient process development strategies. This position will require regular interaction with management from multiple internal functional areas, corporate partners, international regulators and external experts.
The individual will lead and/or participate in cross-functional project teams and work effectively with multiple disciplines and personalities. The candidate will support both US ex-US filings, as appropriate and as requested by corporate partners. Additional responsibilities will include leading departmental operational excellence and business process initiatives, as well as, proactively communicate with Regulatory and cross functional personnel and partners in support of internal and partner associated goals.
|
Experienced | South San Francisco, California | |
| May 21, 2013 |
Sr. Business System Analyst--Med Comm
Job Description The Senior Business Systems Analyst position will work in Medical Communications and is primarily responsible for but not limited to the following;
|
Experienced | South San Francisco, California | |
| May 21, 2013 |
CMC Regulatory Product Manager - Biologics
There is an opportunity in the Technical Regulatory organization at Genentech at the Product Manager level. This position requires use of regulatory and technical knowledge to develop, execute and oversee regulatory initiatives and strategies. This individual will work with cross-functional project teams to develop regulatory strategy and ensure the success of regulatory filings through submission of high quality documents supporting the company’s development product portfolio. Responsibilities will include accountability for IND, IMPD, and BLA/NDA/MAA applications as well as informational and pre-submission meetings with global health authorities, partners, and industry experts. Additional responsibilities include leading departmental business process initiatives, and proactive communication with Regulatory and cross-function personnel and partners. Candidates with a combination of broad technical, process and product development, and CMC regulatory experience are desired. ... |
Experienced | South San Francisco, California | |
| May 21, 2013 |
QC Associate II/Senior QC Associate
Main Purpose of the Position: To develop and maintain automated systems that enhance potency testing that support QC Bioassay operations. Job Duties/Responsibilities:
|
Experienced | Vacaville, California | |
| May 21, 2013 |
Solutions Architect, Workplace Design and Technology Integration
The Solution Architect’s primary responsibilities include:
· Work with vendors, architecture, operations, and solution owners managing the prototyping and evaluation of scenarios. · Ensure efforts and solutions align and adhere to the Pharma Informatics organization’s Technical Architecture Framework (TAF) policies, standards and direction as well as Solution Owner requirements. · Ensure proper training of support teams on the technology solution. · Stay abreast of operational difficulties and issues; work with support team staff to provide escalation support. · Ensure Quality standards as per company specifications are followed. ... |
Experienced | United States | |
| May 21, 2013 |
QC Associate II (Term)
This is a two year term position. Main Purpose of the Position: Perform analytical, biochemical, and/or biological testing; data review; and/or related activities that support QC Bioassay operations. Job Duties/Responsibilities:
|
Entry Level | Vacaville, California | |
| May 21, 2013 |
Senior Engineer Security & IAM, NALA Region
The Global Engineering team is responsible for making technology happen for Genentech and Roche global by transforming the “technology roadmaps” into live solutions. The Global Engineering team is present in 4 locations: Basel, Madrid, Shanghai and South San Francisco, covering all time zones with around 100 highly qualified engineers. The Senior Engineer Security & IAM, NALA Region position is located at the South San Francisco site. The main responsibilities of the position are:
|
Experienced | South San Francisco, California | |
| May 21, 2013 |
Software Developer
Are you ready to create something that makes a real difference in people’s lives, rather than just a cool widget for the next internet startup? What about creating tools that enable scientists and engineers to optimize cutting edge biochemical manufacturing processes that produce live-saving medicines for cancer and other unmet medical needs? We do all of that at Genentech. We have a small team that utilizes both agile and waterfall approaches (when it suits us) to create novel tools in a biotech manufacturing environment. We create applications that simply do not exist in this industry – but are vitally necessary to advance the science of delivering new drugs that save lives. We need someone to help develop and maintain applications in Perl, Ruby, ASP.NET, and some other platforms. We do not require experience in all of these technologies, only a willingness to learn and expand your toolkit. You will be responsible for the development and maintenance of the systems you build. You will be required to work both independently and also be part of a team. You are an excellent communicator and have a can-do attitude. Key Responsibilities: • Working with small teams, design, develop, test, document and implement GxP solutions based on customer requirements and translate them into functional solutions |
Experienced | South San Francisco, California | |
| May 21, 2013 |
Medical Communication Scientist
Medical Communications Scientist is able tocommunicate relevant, timely, accurate, and balanced clinical information onGenentech's products, positively influencing their safe and effective use.
DESCRIPTION: The Medical Communications Scientist is able tocommunicate relevant, timely, accurate, and balanced clinical information onGenentech's products, positively influencing their safe and effective use. Ableto evaluate medical literature as well as write, review, edit, and approvemedical content to ensure appropriate clinical context and accuracy. Providesmedical responses through various communication channels (response documents,web-based media, scientific meetings, etc.). Is also able to provide trainingrelevant to Genentech's product portfolio. Has a basic understanding oflegal/regulatory topics adequate to describe the basis of Medical Affairspolicies and procedures, and applies this knowledge to the review ofpromotional materials and Medical Affairs documents. The Medical Communications Scientist is able to assist in the development andimplementation of Medical Communication policies and procedures, establish andsupervise the work flow for delegated projects, and assess incoming requestinformation to determine required action and triage based on internal policiesand procedures. Can convey and acquire medical information as well ascommunicate and work effectively with members of the Medical Communicationsstaff and customers which include but are not limited to: Sales, Marketing,Managed Care, Clinical Development, Product Safety, Regulatory, Legal, andCorporate Partners. ... |
Experienced | South San Francisco, California | |
| May 21, 2013 |
QC Supervisor/Senior Supervisor
Main Purpose of the Position:
Job Duties/Responsibilities:
Technical Duties/Responsibilities:
|
Manager with Direct Reports | Vacaville, California | |
| May 21, 2013 |
Maintenence Mechanic/Sr. Maintenence Mechanic
Job Responsibilities:
• Maintenance, repair, fault diagnosis and troubleshooting of manufacturing process equipment and support equipment. • Timely completion of tasks and work orders with appropriate documentation according to standard operating procedures, applicable standards, guidelines, practices, and policies. • Safe operation of tools and shop equipment, and safe execution of work in the field. • Confined Space Entry in accordance with all applicable laws, regulations, and policies. • Ability to read and understand Piping and Instrumentation Drawings. • Basic computer skills, with the ability to utilize the corporate intranet and applications, CMMS, and standard word processing and spreadsheet programs. • Interact and communicate appropriately with Manufacturing, Quality, Technology, and Engineering to ensure satisfactory performance of mechanical systems. • Represent Maintenance Operations on multidisciplinary project teams.... |
Experienced | Vacaville, California | |
| May 21, 2013 |
Senior Business Systems Analyst - Biometrics & Clincal Operations
The Business Solution Manager (BSM) position is part of a global team that supports Product Development Biometrics & Clinical Operations. This role includes working on major cross-functional system initiatives, providing user support, system upgrades/enhancements, and business case development as well as integrating business processes and technology. In this role the BSM proactively assesses upcoming changes in Statistical Analysis tools and internal business environments, in compliance with the IT standards/processes and identifies solutions in support of the following areas:
The BSM will also support cross functional initiatives led by other business areas and provide process expertise to support the development of solutions that align with the Product Development Information Landscape & Biometrics Information Landscape roadmaps.
In partnership with Biometrics & Clinical Operations, Project Management and Delivery Services, the BSM responsibilities include but are not limited to:
|
Experienced | South San Francisco, California | |
| May 21, 2013 |
Senior Engineer
Purpose: The senior utilities engineer provides technical leadership and accountability for plant and GMP utilities engineering in the delivery of capital projects and engineering services for research and development (R&D) and quality laboratory, as well as commercial and clinical manufacturing related facilities.
• The senior utilities engineer will work effectively on multi-discipline engineering capital project teams, as well as other project related cross-functional teams with representatives from departments throughout the Pharmaceutical Technical Operations and R&D organizations. • Responsibilities may extend to all regional Americas manufacturing and research facilities, as well as the network of Contract Manufacturing Organizations organized under the Manufacturing Collaborations group. • The primary area of focus for this position will be the execution of projects from design through commissioning and qualification. The senior utilities engineer will be accountable for: - Planning and Execution of Projects: including project approach and resource needs, options analysis, utility systems and equipment design, engineering document development, and system ownership through the project delivery phases of plan, design, procure, construct, commission and qualification for research, cGMP and development facilities; and - Technical Analysis: including utility system and technology plant fits, capacity and equipment utilization, value engineering, sustainable design, constructability and assessment of applicable new technologies to balance performance, cost and maintainability. • Areas of expertise include systems and equipment for purified water, water for injection (WFI), clean steam, process air, process gases and process waste, as well as associated knowledge in plant steam, plant chillers and utility piping. • This position requires coordination of Genentech/ Roche and/or contract engineering resources. Facilitating meetings, directing engineering firms and consultants, field supervision, equipment inspection and start-up, construction trade coordination, and training of operational staff are often required. Success in these areas will depend upon the individual’s ability to effectively communicate, collaborate, and foster positive interactions with team members, while diligently managing adherence to project scope, budget and schedule. • The senior engineer is expected to be an effective communicator of ideas, project goals and results. With minimal supervision, is expected to make presentations and updates to senior management and in broader forums both internal and external to Genentech. • The senior engineer is expected to contribute to increasing the efficiency and effectiveness of the Engineering Technology department by contributing toward infrastructure improvements to guidelines, procedures, practices, standards and cross-functional business processes. The senior engineer should share insights and improvements, participate in design reviews across the portfolio of departmental projects, and contribute to best practice forums across our network of global engineers and partners. ... |
Experienced | South San Francisco, California | |
| May 21, 2013 |
Delivery Service Manager
The PD Biometrics and Clinical Sciences Informatics (FPPO) team is looking for a highly skilled Delivery Service Manager, who will support the Biostatistics, EpiPRO, and Thesaurus Management systems area. This candidate will be able to deal with a diverse and multicultural, global team in varied time zones, who is proactive, outgoing and detail- oriented with excellent problem solving, and written/verbal communication skills. Further responsibilities are:
|
Experienced | South San Francisco, California | |
| 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 |
QA Associate II
Main Purpose of the Position:
Job Duties/Responsibilities:
Technical Duties/Responsibilities:
|
Experienced | South San Francisco, California | |
| May 21, 2013 |
Medical Science Liaison - Arizona, New Mexico, San Diego, Orange County, and Southern Nevada
MSL-Oncology The states covered are Arizona, New Mexico, San Diego, Orange County, and Southern Nevada Main Purpose of the Position:
Job Duties/Responsibilities: General:
Clinical trial support: MSLs interact with Genentech Medical Directors and their designees to determine and coordinate health care practitioner, researcher, and investigator activities.. MSLs act as the conduit between external customers and the Genentech Medical Directors.
Customer/Investigator support:
Commercial support: |
Experienced | South San Francisco, 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.
|
Experienced | Oceanside, California | |
| May 21, 2013 |
Senior Regulatory Product Manager/ Reg. Scientist
The Technical Regulatory Senior Product Manager will be responsible for developing global regulatory strategy, writing high quality dossiers, and leading teams for assigned projects to obtain timely approvals of Genentech applications. This position will require regular interaction with management from multiple internal functional areas, corporate partners, international regulators and external experts.
The Senior Product Manager will lead and/or participate in cross-functional project teams and work effectively with multiple disciplines and personalities. The candidate will support US and ex-US filings, as appropriate. Additional responsibilities will include leading departmental business process initiatives as well as proactively communicating with Technical Regulatory and cross functional personnel and partners in support of internal and partner associated goals.
|
Experienced | South San Francisco, California |
Job Feeds
You Might Also Be Interested In
- Global Opportunities
Search for jobs via Roche.
- Meet Our Employees
Get to know some of the people behind our medicines.
- Professional Areas
We offer exceptional opportunities in all areas.
