Technical Program Manager

LabConnect • Johnson City, TN

5d

About The Position

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 Technical Program Manager will be responsible for providing program management and oversight to a biopharmaceutical client tasked with managing a portfolio of specialized project deliverables and programs spanning diagnostics and novel endpoints. He/she will provide project management and technical support to cross-functional teams and stakeholders, developing project workstreams, conducting risk management, timeline and budget oversight, and managing contracts. The Technical Program Manager must have the ability to effectively manage and monitor the progress and deliverables across multiple functional areas within the project, coordinating the efforts of each cross-functional team within the program toward product approval and deployment. The incumbent will also be responsible for managing operational documentation and maintaining shared sites, folders, dashboards, budget trackers and critical regulatory and decision-making documents.

Requirements

• A thorough understanding of bioanalytical methods with a focus on pathology, biomarkers, precision medicine, oncology, bioinformatics
• Experience in bioanalytical method development, validation, formal technical transfer of methods and method performance monitoring.
• Strong assay and process troubleshooting skills.
• Strong communication skills.
• Cross-functional and cross-site team management experience.
• CRO performance and relationship management experience.
• Working knowledge of Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and/or Clinical Laboratory Improvement Amendments (CLIA)
• Proficiency in technical writing and document control.
• Common and specialized computer software application proficiency and adaptability.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• To perform this job successfully, an individual should have advanced knowledge of Microsoft Office applications including Word, Excel, and Power Point.
• M.S., Life Sciences or related field with a minimum of 2 years of industry-relevant project, laboratory and management experience, or
• B.S., Life Sciences or related field with a minimum of 5 years of industry-relevant project, laboratory and management experience and best practices.

Responsibilities

• Provide program management and oversight, including:
• Preparing the agenda and leading the weekly cross-functional team
• Capture key decisions and action items along with rationale and reasoning
• Follow up on action items with responsible parties to ascertain timely resolution
• Proactively reach to stakeholders offline and schedule smaller group meetings as needed
• Generate and maintain PowerPoint presentations for key meetings
• Develop and maintain shared sites/folders/dashboards/budget trackers and key regulatory and decision-making documents
• Oversee all program activities, including identifying and mitigating risks, developing project workstreams, and managing ongoing contracting efforts and processes
• Manage the efforts to develop precision medicine and digital pathology solutions by organizing and coordinating the cross-functional efforts and collaboration towards product approval and deployment
• Provide project management oversight and subject matter expertise in GLP bioanalytical testing, method development, validation and technical transfer to ensure scientific integrity and adherence to the protocol/plan/contracts and applicable regulations.
• Interact with U.S. and international CROs and effectively communicate updates, reports and recommendations to management teams.
• Provide analytical project oversight by performing data review and trending analysis, evaluate assay quality, monitor performance and manage timelines.
• Provide technical support to troubleshoot specific issues that impact the project.
• Manage Supplier performance and relationships with attention toward opportunities to cut costs, alleviate risks and drive continuous improvement.
• Recommend and implement new processes and procedures to standardize, simplify and enhance quality and compliance of the department’s operations.
• Expected to participate in the management and control of GLP documentation and records, and contribute to and (co) author scientific and/or operational documents such as SOPs, validation protocols and reports, transfer protocols and reports, posters, journal publications and other technical reports.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level