Laboratory Vendor Specialist, Clinical Operations

Vacancy NameLaboratory Vendor Specialist, Clinical Operations Vacancy NoVN868 Employment TypeFull Time Location of roleGaithersburg, MD, Radnor, PA DepartmentClinical Operations Key ResponsibilitiesThe Laboratory Vendor Specialist is responsible for supporting the oversight and management of Immunocore's relationships with multiple laboratory vendors. This is an office-based position with flexibility.

The Laboratory Vendor Specialist will support the day-to-day management of samples and lab vendors assigned to them. Works with Clinical Operations (Clin Ops), Translational Medicine, Data Management, and appropriate departments to support centralized clinical trials sample management, as well as specific project/study or a business/therapeutic area needs. Managing/supporting study teams with lab set up; including vendor selection, early protocol input and creating documents.

The Lab Vendor Specialist will be expected to develop a strong knowledge of external central and third-party testing lab(s) processes and ensure lab vendors contracted, IMC Clinical Study Teams, and CRO staff reporting to them have the proper support. The Lab Vendor Manager will ensure proper vendor setup, governance, and timeline development for key trial deliverables involving the lab vendors and the Lab Vendor Specialist will support these efforts. The lab vendor specialist will assist with managing/supporting study teams with lab set up, including vendor selection, early protocol input, and creating protocol specific documents.

This position requires both hands-on study and lab vendor management support. Immunocore's ideal candidate possesses knowledge of GxP, FDA regulations, vendor-sponsor best practices, strong technical skills, can support infrastructure assessment and improvement, and is a self-starter. This lab vendor specialist has a crucial role that will assist in ensuring that all vendors meet Immunocore's standards for quality, efficiency, and compliance in conducting Phase 1, 2, and 3 clinical trials.

Key Responsibilities:

• Assist with the development and approval of controlled documents related to clinical study.
• Support Vendor Selection and Onboarding
• Assist in the evaluation, selection, and onboarding of laboratory vendors.
• Quality Metrics:
• Assist in the development of KPI's for lab vendors, supporting, monitoring, and evaluation of the lab vendor performance.
• Lab vendor invoice review
• Assist in the review of lab vendor invoices, ensuring they align with contracted terms.
• Compliance:
• Assist in raising lab vendor quality compliance issues with Immunocore's internal QA team.
• Assist in identifying, developing, and implementing risk mitigation strategies associated with lab vendors as needed across IMC programs.
• Support and assist in the preparation of internal and external clinical operations teams for laboratory vendor audits.
• Reporting:
• Assist in downloading and disbursing lab vendor reports provided by laboratory vendor.
• Assist in compiling reports on lab vendor performance, cost-effectiveness, and compliance to share with the internal study team and stakeholders.
• Continuous Improvement:
• Identify opportunities for process improvements within Immunocore current processes.
• Assist is identifying cost saving initiatives to implement with laboratory vendors.
• Review lab vendor audit reports with clinical management.
• Protocol Lifecycle support
• Preparation and review of clinical study documents such as but not limited to the laboratory specification documents, sample management plans, and laboratory manuals.
• Support study specific trainings
• Track external sample shipments from site collection through third-party vendor receipt, with close monitoring on potentially delayed or missing samples to ensure accurate data delivery to meet study timelines.
• Works collaboratively with key stakeholders (e.g., Clinical study teams, Clinical Study Sites, and external lab vendors) to ensure proper alignment and study level execution of scientific and operational strategies of the lab vendors assigned.
• Transcribe internal and external lab vendor/sample management meetings on specified cadence; contributes as a sample management representative at interdepartmental meetings, study conduct/governance meetings and is responsible for filing these meeting minutes to IMC's internal TMF.
• Manage lab vendor access reports and ensure laboratory vendors are kept up to date on protocol contacts.

Other Duties:

• Direct and train on Clinical Standard Operating Procedures and to ensure compliance with regulatory organizations.
• Organize pre- and post-study document reviews and takes corrective action.
• Assist leadership in continuous improvement of good clinical practices.
• Drives timely completion of assigned goals and organizational changes within the organization.
• Leads by example to create a positive work environment, encouraging mutual respect, accountability, smart risks, and innovation.
• Offers help, support, and knowledge to drive for success across the organization and company.
• Regularly interact with senior management or executive levels on matters concerning several functional areas

Education, Experience and Knowledge:

Essential Qualifications:

• 3 + years, of laboratory operations, pharmaceutical or biotech-related/experience required.
• Experience working in a matrix environment, assisting leadership across multiple studies.
• Demonstrated computer skills; proven functional knowledge of Microsoft packages (MS Word, Excel, Power Point, Outlook, MS Project, SharePoint) and ability to develop proficiency in relevant sponsor systems and programs.
• Strong communications and organizational skills
• GXP compliant

Non-Essential Qualifications:

Prior experience with the following would be advantageous.

• Risk Management
• Sample Management
• Process Improvements

US Salary Range

$101,000- $115,000 About the CompanyImmunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry's most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients' lives, advancing medicine, and supporting one another in these pursuits.

Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.