Manager, Clinical Trial Flow Cytometry - CAR-T
- Location
- Carlsbad, CA
- Posted
- Jun 27, 2022
- Ref
- 346125BR
- Discipline
- Clinical, Clinical Research, Clinical Trials
- Hotbed
- Biotech Beach
- Required Education
- Bachelors Degree
- Position Type
- Full time
1 in 5 men and 1 in 6 women worldwide develop cancer during their lifetime, and far too many will lose their battle every year. At Navigate we envision a disease free world – our talented and passionate team is at the forefront of enabling drug development by using transformative science to deliver high quality, world class clinical biomarker solutions so we can one day realize that vision. Join us on our journey to turning innovative treatment ideas into reality to improve and extend patient lives across the globe. Navigate Biopharma, a fully owned subsidiary of Novartis, provides assay development, clinical trial testing, and companion diagnostics services to companies in the precision medicine field. At present, Navigate supports 100+ clinical trials from 30+ pharma, biotech, and diagnostic companies, including 8 of the top 15 oncology companies globally.
The Manager, Clinical Trial Flow Cytometry will manage technical and laboratory aspects of multi-parameter flow cytometry based PK/PD biomarker clinical trial testing projects. Will manage performance and mentoring of other associates. Serve as the key point of contact for other functional teams, departments, and external partners. Works closely with directors and leadership team. Will participate on cross-functional teams and projects. Executes and troubleshoot new procedures and assays with high level of independence while working on multiple projects. Serve as technical lead for execution of clinical sample testing from concept to completion. Evaluates test data, reviews associated documentation, writes bioanalytical reports and supports the team with adherence to appropriate quality regulations. Provides key scientific knowledge to drive success of strategic activities. Ability to forge relationships with scientists at all levels and provide guidance. Develop timelines and work flows to ensure successful execution of assigned projects and processes. Strategizes to identify and mitigate risks. Makes recommendations for scientific processes and drives projects to completion.
Key responsibilities:
• Works in a GMP/GCP/GLP/CLIA regulated environment and is responsible for following all applicable regulations
• Provides guidance, instruction, direction and leadership to a group of scientists in their assigned functional/technical area
• Ensure all team members are aligned of team goals and work together to achieve the collective goals of the team.
• Manage team resources and communicate any issues and team concerns effectively to management
• Manage multiple projects simultaneously and under tight timelines
• Act as a Subject matter expert related to operational processes in the functional area
• Responsible for writing and reviewing technical documents
Other Responsiblities:
• Ensuring that Quality Events such as incidents and deviations are proper documented, and for supporting/owning the immediate remediation and preventative actions
• Ensuring change requests are properly initiated, completed, and approved prior to the use of the assay, system, instrument, software, etc. being changed
• Maintaining up-to-date training records and ensuring training is complete prior to performing specific job functions
• Following approved and effective procedures to perform specific job functions, and ensuring procedures accurately reflect activities being performed
EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Minimum requirements What you will bring to the role:
• Ph.D. with a minimum of eight (8) years, masters or CLS with minimum of twelve (12) years or bachelors with minimum of fifteen (15) years relevant experience
• Minimum of five (5) years’ experience in pharmaceutical, drug development or diagnostic/clinical laboratory setting
• Minimum of five (5) years supervisory experience
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you are given opportunities to explore the power of digital and data. Where you are empowered to risk failure by taking smart risks, and where you are surrounded by people who share your determination to tackle the world’s toughest medical challenges.
We are Novartis. Join us and help us reimagine medicine.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
Accessibility and Reasonable Accommodations:
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [email protected]
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Division ONCOLOGY Business Unit NAVIGATE BIOPHARMA SERVICES Location USA Site Carlsbad, CA Company/Legal Entity Navigate BioPharma Svcs., Inc. Functional Area Research & Development Job Type Full Time Employment Type Regular Shift Work No
The Manager, Clinical Trial Flow Cytometry will manage technical and laboratory aspects of multi-parameter flow cytometry based PK/PD biomarker clinical trial testing projects. Will manage performance and mentoring of other associates. Serve as the key point of contact for other functional teams, departments, and external partners. Works closely with directors and leadership team. Will participate on cross-functional teams and projects. Executes and troubleshoot new procedures and assays with high level of independence while working on multiple projects. Serve as technical lead for execution of clinical sample testing from concept to completion. Evaluates test data, reviews associated documentation, writes bioanalytical reports and supports the team with adherence to appropriate quality regulations. Provides key scientific knowledge to drive success of strategic activities. Ability to forge relationships with scientists at all levels and provide guidance. Develop timelines and work flows to ensure successful execution of assigned projects and processes. Strategizes to identify and mitigate risks. Makes recommendations for scientific processes and drives projects to completion.
Key responsibilities:
• Works in a GMP/GCP/GLP/CLIA regulated environment and is responsible for following all applicable regulations
• Provides guidance, instruction, direction and leadership to a group of scientists in their assigned functional/technical area
• Ensure all team members are aligned of team goals and work together to achieve the collective goals of the team.
• Manage team resources and communicate any issues and team concerns effectively to management
• Manage multiple projects simultaneously and under tight timelines
• Act as a Subject matter expert related to operational processes in the functional area
• Responsible for writing and reviewing technical documents
Other Responsiblities:
• Ensuring that Quality Events such as incidents and deviations are proper documented, and for supporting/owning the immediate remediation and preventative actions
• Ensuring change requests are properly initiated, completed, and approved prior to the use of the assay, system, instrument, software, etc. being changed
• Maintaining up-to-date training records and ensuring training is complete prior to performing specific job functions
• Following approved and effective procedures to perform specific job functions, and ensuring procedures accurately reflect activities being performed
EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Minimum requirements What you will bring to the role:
• Ph.D. with a minimum of eight (8) years, masters or CLS with minimum of twelve (12) years or bachelors with minimum of fifteen (15) years relevant experience
• Minimum of five (5) years’ experience in pharmaceutical, drug development or diagnostic/clinical laboratory setting
• Minimum of five (5) years supervisory experience
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you are given opportunities to explore the power of digital and data. Where you are empowered to risk failure by taking smart risks, and where you are surrounded by people who share your determination to tackle the world’s toughest medical challenges.
We are Novartis. Join us and help us reimagine medicine.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
Accessibility and Reasonable Accommodations:
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [email protected]
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Division ONCOLOGY Business Unit NAVIGATE BIOPHARMA SERVICES Location USA Site Carlsbad, CA Company/Legal Entity Navigate BioPharma Svcs., Inc. Functional Area Research & Development Job Type Full Time Employment Type Regular Shift Work No