Scientific Project Manager
Overview
LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world.
We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions.
The Scientific Project Manager supports the implementation and communication outsourcing processes and practices. Responsible for providing project management and subject matter expertise oversight of outsourced analytical testing, method development and validation of assays in the areas of flow cytometry, genomics/genetics and/or immunogenicity.
Please note: this is a fully remote role, best suited for candidates located in the Pacific Time Zone or able to work Pacific Time hours, and will require travel at least twice per year to the client site, as well as occasional travel to vendor laboratories as needed.
Essential Duties and Responsibilities
Study Monitoring
• Coordinate outsourcing activities with analytical method performance oversight and timeline management of clinical studies involving large molecule bioanalytical assays in one or more of the following areas: flow cytometry, genomics/genetics and/or immunogenicity.
• The initial point of contact between external vendors and internal stakeholders for outsourcing issue resolution, vendor capacity & capability management.
• Provide technical support to troubleshoot specific issues that impact the project.
• Ensure contracted studies are conducted in compliance with the respective protocol and applicable guidelines & regulations
Tech Transfer
• Implements transfer strategy and coordinates between the product team and technical experts.
• Responsible for establishing production phase monitoring requirements (PT and trending)
• Technical monitoring of assay performance and evaluation of transfer pass/fail criteria.
• Strong technical understanding in one or more of the following areas: flow cytometry, genomics/genetics and immunogenicity
• Ensures vendor adherence to project plan.
Supplier Management
• Lead operational point of contact between vendor and client
• Manage supplier performance and relationships with attention toward opportunities to cut costs, alleviate risks and drive continuous improvement.
Department Support
• Assist with writing SOPs for new laboratories
• Assist with developing and implementing training documents and plans.
• Assist with process improvement initiatives
Education and Experience
• B.S. in Life Sciences or related field.
• Minimum of 5 years of industry-relevant project, laboratory, and management experience.
• Demonstrated experience supporting immunogenicity programs, including anti-drug antibody (ADA) assessments, in a regulated bioanalytical or clinical development environment.
• Proven ability to perform data trending, analysis, and visualization using R (RStudio), JMP, and Minitab.
Join our team and discover how your work can impact patients' lives around the world!
Some of the Perks our LabConnectors Love:
• Financial Security (Base Pay, 401k Match and Possible Annual Bonus Eligibility)
• Health Benefits beginning on date of hire
• PTO plan, plus 11 Paid Company Holidays, and 1 Day to Volunteer in your community
• Short and Long-Term Disability, Life Insurance, and AD&D
• We celebrate our differences, which enriches our culture!
In addition to great perks and challenging work assignments, we invest in our people with career growth opportunities, globally. We believe in a friendly and collaborative environment with open lines of communication. While living out our values of People First, Quality Focused, Customer Centered, Technology Driven, and Accountability Always.
We are proud to be an Equal Employment Opportunity Employer and value the diversity of our workforce. We do not discriminate on the basis of race, gender, age, disability, religion, sexual orientation, or any other protected characteristic. To learn more about equal employment opportunity, please view the posters here: https://www.dol.gov/agencies/whd/posters
LabConnect also prioritizes the privacy and security of your personal data. All candidate information is handled in accordance with General Data Protection Regulation (GDPR). To learn more, please review our Privacy Notice on our website, by navigating to https://www.labconnect.com/
If you need assistance to complete your job application, search for a job opening, or submit an online application at LabConnect, please email [email protected] or call +1 (423) 722-3155.
Apply tot his job
Apply To this Job
LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world.
We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions.
The Scientific Project Manager supports the implementation and communication outsourcing processes and practices. Responsible for providing project management and subject matter expertise oversight of outsourced analytical testing, method development and validation of assays in the areas of flow cytometry, genomics/genetics and/or immunogenicity.
Please note: this is a fully remote role, best suited for candidates located in the Pacific Time Zone or able to work Pacific Time hours, and will require travel at least twice per year to the client site, as well as occasional travel to vendor laboratories as needed.
Essential Duties and Responsibilities
Study Monitoring
• Coordinate outsourcing activities with analytical method performance oversight and timeline management of clinical studies involving large molecule bioanalytical assays in one or more of the following areas: flow cytometry, genomics/genetics and/or immunogenicity.
• The initial point of contact between external vendors and internal stakeholders for outsourcing issue resolution, vendor capacity & capability management.
• Provide technical support to troubleshoot specific issues that impact the project.
• Ensure contracted studies are conducted in compliance with the respective protocol and applicable guidelines & regulations
Tech Transfer
• Implements transfer strategy and coordinates between the product team and technical experts.
• Responsible for establishing production phase monitoring requirements (PT and trending)
• Technical monitoring of assay performance and evaluation of transfer pass/fail criteria.
• Strong technical understanding in one or more of the following areas: flow cytometry, genomics/genetics and immunogenicity
• Ensures vendor adherence to project plan.
Supplier Management
• Lead operational point of contact between vendor and client
• Manage supplier performance and relationships with attention toward opportunities to cut costs, alleviate risks and drive continuous improvement.
Department Support
• Assist with writing SOPs for new laboratories
• Assist with developing and implementing training documents and plans.
• Assist with process improvement initiatives
Education and Experience
• B.S. in Life Sciences or related field.
• Minimum of 5 years of industry-relevant project, laboratory, and management experience.
• Demonstrated experience supporting immunogenicity programs, including anti-drug antibody (ADA) assessments, in a regulated bioanalytical or clinical development environment.
• Proven ability to perform data trending, analysis, and visualization using R (RStudio), JMP, and Minitab.
Join our team and discover how your work can impact patients' lives around the world!
Some of the Perks our LabConnectors Love:
• Financial Security (Base Pay, 401k Match and Possible Annual Bonus Eligibility)
• Health Benefits beginning on date of hire
• PTO plan, plus 11 Paid Company Holidays, and 1 Day to Volunteer in your community
• Short and Long-Term Disability, Life Insurance, and AD&D
• We celebrate our differences, which enriches our culture!
In addition to great perks and challenging work assignments, we invest in our people with career growth opportunities, globally. We believe in a friendly and collaborative environment with open lines of communication. While living out our values of People First, Quality Focused, Customer Centered, Technology Driven, and Accountability Always.
We are proud to be an Equal Employment Opportunity Employer and value the diversity of our workforce. We do not discriminate on the basis of race, gender, age, disability, religion, sexual orientation, or any other protected characteristic. To learn more about equal employment opportunity, please view the posters here: https://www.dol.gov/agencies/whd/posters
LabConnect also prioritizes the privacy and security of your personal data. All candidate information is handled in accordance with General Data Protection Regulation (GDPR). To learn more, please review our Privacy Notice on our website, by navigating to https://www.labconnect.com/
If you need assistance to complete your job application, search for a job opening, or submit an online application at LabConnect, please email [email protected] or call +1 (423) 722-3155.
Apply tot his job
Apply To this Job