Contract Biologic Coordinator Jobs in Raleigh, NC

Our Company

35 North is a full-service program and project management firm that provides consulting, construction, cost, and commissioning solutions for capital projects. Expand your career and discover opportunities with

35 North!

The Position

We are seeking an experienced Project Executive who will serve as the owners' representatives on complex construction project settings within the Life Science, Pharmaceutical, and Biotechnology market sectors. This role requires a strong focus on stakeholder management, the development and execution of strategic plans, and driving alignment between cross-functional teams and organizational goals. The successful candidate will lead efforts in project planning, budgeting, and negotiation. You will be responsible for ensuring seamless coordination across teams, managing client relationships, and overseeing the successful delivery of critical initiatives in the life sciences sector.

This is a full-time, permanent position and could alternate between our HQ office located in Durham, NC, and client locations.

Responsibilities

• Oversee and direct construction projects from conception to completion.
• Work with customer's representatives and general contractor to develop project execution strategy, logistics plans, and project-specific safety plans.
• Support clients in the project setup process; including construction contract reviews, staff plans, budgets, and project processes.
• Prepare construction budget based on scope of work and resource requirements. Track project costs to meet construction budget.
• Develop and manage a detailed project schedule and work plan.
• Perform periodic walkthroughs of the construction site and provide feedback to the general contractor and subcontractors.
• Develop and manage quality control, document control, and communication plans.
• Conduct thorough reviews of construction documents to ensure compliance with project scope, standards, and regulations. Manage the documentation process to maintain accuracy and consistency throughout the project lifecycle.
• Regularly monitor and track the status of capital projects, including budget, schedule, and quality performance. Prepare and present detailed project reports to senior leadership and stakeholders, including identifying risks and resolving project issues.
• Identify areas for improvement in program and project delivery. Develop and implement interventions to enhance efficiency, quality, and safety across all projects.
• Regularly contributes to strategic planning discussions, providing recommendations and insights to drive organizational success. Prepare comprehensive reports on project status, financial health, and overall performance.
• Manage contracts with contractors and consultants.
• Work collaboratively and build effective relationships with Client's project team, owners and final users, design team, contractors, and local jurisdictional personnel.
• Maintain a positive attitude in a fast-paced environment.

Required Qualifications:

• 15-20 years of experience in managing complex life science capital projects, with demonstrated expertise in stakeholder management, strategic planning, and cross-functional leadership.
• Bachelor's degree in engineering, construction management, facilities management, or a related technical field; or equivalent experience.
• Proven track record in managing large-scale projects (>$20M) within the life science sector, including new construction, renovation, and infrastructure upgrades.
• Substantial experience with cGMP facility design, build, qualification, and maintenance.
• Experience with the design, construction, commissioning, and operation of pharmaceutical, biotechnology, and/or general life sciences facilities and infrastructure.
• Experienced leader, with knowledge of program management, project management, project controls, construction management, commissioning, and qualification services in regulated environments.
• Strong experience in project budgeting, scoping, and estimating, including managing capital project financials.
• Proven ability to lead cross-functional teams, build strong stakeholder relationships, and manage multiple high-priority projects simultaneously.
• Strong interpersonal skills with the ability to influence stakeholders, manage conflicts, and build consensus.
• Exceptional communication skills, both verbal and written, with an ability to present data clearly and concisely to senior leaders and stakeholders.
• Experience working on regulated industries and knowledge of regulatory and compliance requirements: FDA regulations, Good Engineering Practices (GEP), current Good Manufacturing Practices (cGMP), and Good Documentation Practices (GDP).
• Familiarity with the Code of Federal Regulations (CFR) as related to cGMP in Manufacturing, Processing, Packaging, and Holding of Drugs and Finished Pharmaceuticals; Dietary Supplement & Human Food; Biological Products & General Biological Products Standards; Good Clinical Practices for Medical Devices; and Quality Systems Regulations.
• Previous project experience in one or more of the following technologies and platforms: manufacturing and utilities systems; clean and aseptic rooms; clean-in-place (CIP); steam-in-place (SIP); autoclaves; vapor hydrogen peroxide (VHP) sterilization; solid dose preparation areas; powder feeding and continuous manufacturing; blending, milling, granulation, and formulation; fermentation, purification, and conjugation processes,; controlled temperature environments; injectables sterile fill and packaging facilities; conveyors and clean packaging automation; GMP warehousing; and, automated storage and retrieval warehouse systems.

Physical and Other Requirements

• The job requires both office and site-based work, including travel to job sites in various weather conditions.
• On-site safety gear (e.g., hard hat, glasses, safety harness) is required.
• Ability to traverse construction sites and perform inspections in various weather conditions.
• May involve lifting up to 30 lbs. (13.6 kg) and extended periods of sitting or using office equipment.
• May require travel.
• Must have valid driver's license.

35Northoffersacompetitivebenefitspackagethatincludes

• 401kwith3%employercontribution
• Cell phone allowance
• Employerpaidlifeinsuranceandlong-termdisability
• Fullmedical,dental,andvisionbenefits
• Paidtime-offandholidays

35 North is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status, or any other characteristic protected by local, state, or federal laws, rules or regulations. Formoreinformationabout35North,visit35N.com.