Find Jobs (Post Jobs)
- Accounting / Finance Jobs (14697)
- Architect / Engineering Jobs (4029)
- Business and Management Jobs (2727)
- Environmental Jobs (14686)
- Government Jobs (190087)
- Health Care Jobs (4771)
- Hospitality Jobs (21581)
- Janitorial Jobs (2457)
- Legal Jobs (12150)
- Nanny Jobs / Babysitting (6)
- Office Jobs (89255)
- Other Jobs (853)
- Retail / Wholesale Jobs (10970)
- Sales Jobs (10970)
- Science (17385)
- Security (3621)
- Skilled Trades / Crafts (4029)
- Transportation Jobs (195)
- Travel / Transportation (501)
Jobs By State
- Alabama (205)
- Alaska (178)
- Arizona (1509)
- Arkansas (118)
- California (73044)
- Colorado (491)
- Connecticut (43)
- Delaware (23)
- Florida (413)
- Georgia (381)
- Hawaii (194)
- Idaho (2801)
- Illinois (222)
- Indiana (168)
- Iowa (94)
- Kansas (148)
- Kentucky (228)
- Louisiana (196)
- Maine (57)
- Maryland (551)
- Massachusetts (182)
- Michigan (232)
- Minnesota (153)
- Mississippi (160)
- Missouri (280)
- Montana (163)
- Nebraska (77)
- Nevada (235)
- New Hampshire (35)
- New Jersey (132)
- New Mexico (329)
- New York (329)
- North Carolina (313)
- North Dakota (91)
- Ohio (236)
- Oklahoma (201)
- Oregon (150)
- Pennsylvania (285)
- Rhode Island (19)
- South Carolina (175)
- South Dakota (128)
- Tennessee (142)
- Texas (804)
- Utah (5452)
- Vermont (43)
- Virginia (756)
- Washington (32241)
- West Virginia (147)
- Wisconsin (118)
- Wyoming (147)
100,000's of Government Jobs
Search Government Jobs
BIOANALYTICAL MANAGER
Job Field: Office Jobs
Location: United States, CA
Salary: $Not stated
Location: United States, CA
Salary: $Not stated
JOB SUMMARY:
</tr>
<tr><td valign="top" width="450"><b>Job ID:00408316Job95of371BioAnalytical ManagerSouth San Francisco, CaliforniaJob factsJob functionDevelopmentLocationUnited States - CaliforniaSouth San FranciscoCompany / DivisionPharmaceuticalsScheduleFull-timeJob typeRegular EmployeeJob levelTeam LeaderServiceDirect linkApply OnlinePrintWho We AreAt the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we''ve become one of the world''s leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.The PositionBio-analytical Sciences (BAS) develops, implements and provides strategic direction for state of the art bio-analytical methods and automation systems. BAS data and expertise enable the characterization of the pharmacokinetic, immunogenic and in-vitro biological activities of Genentech bio-therapeutics during drug development and throughout theproduct life cycle.The Bio-analytical Manager (BAM) is a project management role inBAS. BAM works with clinical study teams, contracting group, data group, DMPK, BAS, central labs and contract labs to outsource and managebio-sample (PK/ATA) analysis.BAM will also coordinate technical transfer of in-house developed assay methods to contract labs and will provide on-going first-line technical oversight to contract labs for these assay methods.The BAM is simultaneously assignedto multiple studies and is an agenda-driven ad-hoc member of the clinical study management team (SMT) for each study.The responsibilities for BioAnalytical Manager include:* Driving the development of assay vendor SOWs, managing vendor contracts, including review of invoices, ensuring receipt of SOW deliverable, resolving or escalating issues where needed, and closing contracts* Identifying and on-boarding assay vendors including SOW development, budget planning, and specifying data formats* Working with BAS scientific and technical experts to prepare in-house developed assays for outsourcing to contract labs, to oversee assay validations at contract labs, including review of bioanalytical plans and reports, and to ensure that assays are implemented properly sothat study sample analysis could begin, consulting with in-house technical experts as appropriate.* Preparing vendor oversight plans for each contract lab as needed. Ensuring alignment with cross-functional stakeholders and document team decisions in the PK/ATA Sample Flow DiagramDeveloping timelines for PK and ATA data for managing contract labs to ensure samples are tested according to protocol/team timelines, data is returned in the specified format, and all SOW specified deliverables aremet* Reviewing bioanalytical/sample analysis plans and reports, consulting in-house technical experts as appropriate.* Overseeing shipping and receipt of biosamples from central labs to assay laboratoriesProviding biosample metrics and status updates to teams as requested* Supporting clinical study teams (PET/SMT),Pharmacology subteamsthrough attending appropriate meetings as neededServing as the on-going operational point of contact between internal gRED functions and assay vendors for communication regarding sample logistics and availability,batching and testing timelines, reanalysis, and data reportable tracking* Making arrangement for samples and data handling/archiving at the completion of the studyWho You Are* Bachelor
</tr>
<tr><td valign="top" width="450"><b>Job ID:00408316Job95of371BioAnalytical ManagerSouth San Francisco, CaliforniaJob factsJob functionDevelopmentLocationUnited States - CaliforniaSouth San FranciscoCompany / DivisionPharmaceuticalsScheduleFull-timeJob typeRegular EmployeeJob levelTeam LeaderServiceDirect linkApply OnlinePrintWho We AreAt the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we''ve become one of the world''s leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.The PositionBio-analytical Sciences (BAS) develops, implements and provides strategic direction for state of the art bio-analytical methods and automation systems. BAS data and expertise enable the characterization of the pharmacokinetic, immunogenic and in-vitro biological activities of Genentech bio-therapeutics during drug development and throughout theproduct life cycle.The Bio-analytical Manager (BAM) is a project management role inBAS. BAM works with clinical study teams, contracting group, data group, DMPK, BAS, central labs and contract labs to outsource and managebio-sample (PK/ATA) analysis.BAM will also coordinate technical transfer of in-house developed assay methods to contract labs and will provide on-going first-line technical oversight to contract labs for these assay methods.The BAM is simultaneously assignedto multiple studies and is an agenda-driven ad-hoc member of the clinical study management team (SMT) for each study.The responsibilities for BioAnalytical Manager include:* Driving the development of assay vendor SOWs, managing vendor contracts, including review of invoices, ensuring receipt of SOW deliverable, resolving or escalating issues where needed, and closing contracts* Identifying and on-boarding assay vendors including SOW development, budget planning, and specifying data formats* Working with BAS scientific and technical experts to prepare in-house developed assays for outsourcing to contract labs, to oversee assay validations at contract labs, including review of bioanalytical plans and reports, and to ensure that assays are implemented properly sothat study sample analysis could begin, consulting with in-house technical experts as appropriate.* Preparing vendor oversight plans for each contract lab as needed. Ensuring alignment with cross-functional stakeholders and document team decisions in the PK/ATA Sample Flow DiagramDeveloping timelines for PK and ATA data for managing contract labs to ensure samples are tested according to protocol/team timelines, data is returned in the specified format, and all SOW specified deliverables aremet* Reviewing bioanalytical/sample analysis plans and reports, consulting in-house technical experts as appropriate.* Overseeing shipping and receipt of biosamples from central labs to assay laboratoriesProviding biosample metrics and status updates to teams as requested* Supporting clinical study teams (PET/SMT),Pharmacology subteamsthrough attending appropriate meetings as neededServing as the on-going operational point of contact between internal gRED functions and assay vendors for communication regarding sample logistics and availability,batching and testing timelines, reanalysis, and data reportable tracking* Making arrangement for samples and data handling/archiving at the completion of the studyWho You Are* Bachelor
KEY REQUIREMENTS:
Not stated
Tips