Full-time · Durham, US
Our Company
35 North is a full-service program and project management firm that provides consulting, design, construction, cost and commissioning solutions for life sciences capital projects. We are a growing company with many opportunities to make an impact, especially in the high-growth sectors of biotechnology and life sciences. Expand your career and discover opportunities with 35 North.
The Position
The Project Manager is responsible for overseeing construction projects and assuring that projects stay in budget, on schedule, and that quality meets the owner’s objectives and expectations. They work with customers and general contractors to develop a project execution strategy, logistics plans, and project-specific safety plans; as well as support clients in the project setup process; including, construction contract reviews, staff plans, budgets, and project processes.
This is a full-time, permanent position and could alternate between our HQ office located in Durham, NC, and client locations.
Successful candidate may be hired level I, II, III, or Senior based on education + years of relevant experience.
Responsibilities
Oversee and direct construction projects from conception to completion
Work with customers and general contractors to develop project execution strategy, logistic plans, and project-specific safety plans
Support clients in the project setup process; including construction contract reviews, staff plans, budgets, and project processes
Predict and manage construction support resources in an effective and efficient manner
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
Develop subcontractor scopes, buyout, and day-to-day management
Solicit and secure contractors through RFP process
Perform periodic walk-throughs of the construction site and provide feedback to the general contractor and subcontractors
Provide practical knowledge performing construction safety and construction quality control audits
Review and approve submittals from the general contractor and coordinate with engineering
Develop and manage quality control, document control, and communication plans
Provide project updates on a consistent basis to various stakeholders
Solicit and secure contractors and consultants through RFP processes
Manage contracts with contractors and consultants
Utilize industry best current Good Manufacturing Practices (cGMP) during execution.
Monitor progress and adjust as needed
Measure project performance to identify areas for improvement
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
Associates or Bachelors degree in Engineering, Construction Management, Technical Field or Life Sciences Applied Technology OR equivalent combination of education and experience
Desired Qualifications
5+ years of experience for a Project Manager I
8+ years of experience for a Project Manager II
10+ years of experience for a Project Manager III
15+ years of experience for a Senior Project Manager
Contractor’s license is a plus
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 & Other Requirements
The job is performed indoors in a construction office setting and at job sites (indoors and outside)
Protective / safety gear (e.g., hard hat, glasses, safety harness) is required while on site
Activities include extended periods of sitting, movement, and extensive work at a computer and phone
Occasional heavy lifting (30+ lb / 13.6+ kg) can be expected, though exertion of up to 10 lbs. of force is more common. Need good manual dexterity for the use of common office equipment (e.g., computers, mobile devices, copiers)
Must be able to traverse and inspect all areas of job site in all types of weather; this may include walking, climbing, reaching, bending, crawling, or stretching
May require travel
Exposure to characteristic construction site dangers
Must be on-call to address delays, emergencies, severe weather, and other issues at the job site
35 North offers a competitive benefits package that includes:
401k with 3% employer contribution
Bonus Plan
Cell Phone Allowance
Employer paid life insurance and long-term disability
Full medical, dental, and vision benefits
Paid time-off and holidays
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.
For more information about 35 North, visit 35N.com.
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