Full job description 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.
Summary
The Scientific Project Manager within FSP Solutions will support the implementation and communication of outsourcing processes and practices. This person will be 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.
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 Required Education and Skills: B.S., in Life Sciences or related field with 4+ years relevant industry experience (2+ years with a Master's degree) Experience managing projects, including managing timelines, budgeting and forecasting Understanding of drug development and clinical trial processes Proficient with MS Office, MS Project, Smartsheet and SharePoint Strong planning, attention to detail and organizational skills Strong verbal and written communication skills Hours and Location: 100% remote, with the ability to travel 1-2 times per year to client on the west coast Ability to work standard pacific coast time zone hours, with occasional evening meetings Read more below and get ready for your next great employment adventure! Some of the Perks our LabConnectors Love: Financial Security (base pay, 401k match and annual bonus eligibility) Health Benefits beginning on date of hire PTO plan plus 10 Paid Company Holidays and 1 day to Volunteer in your community Short and Long-Term Disability, Life and AD&D We celebrate our differences, which enrich our Culture We are a growing and global team on a mission to create healthier communities by accelerating the development of new medicines. In addition to great perks and challenging work assignments, we invest in our people with enriching career growth opportunities.
We believe in a friendly and collaborative environment with open lines of communication. Join our team and discover how your work can impact the lives of people all over the world.
It is the policy of LabConnect to provide equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information, or any other protected characteristic under applicable law. Equal Employment Opportunity Posters:
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