Pharmaceutical Project Manager

Pharmaceutical Project Manager / Senior Project Manager Indianapolis

The Project Manager / Sr Project Manager (PM) is responsible for overall management of scope, schedule, and budget on capital projects to FDA & EU regulated Advanced Therapeutic industries. The PM is responsible for planning and overseeing projects to ensure they are completed in a timely fashion and within budget. The PM plans and designates project resources, prepares budgets, monitors progress, and keeps stakeholders informed along the project life cycle. Demonstrates that the cGMPnow team is in control of our projects and adding value to the client.

Compensation & Benefits

Salary Compensation Range: $150,000 - $240,000 annual depending on years of relevant experience

Commission Potential Compensation Range: $0 - $50,000+ annual

This position is eligible for healthcare benefits with the employee base premiums 100% paid for by the company, enrollment in a retirement savings plan with company contributions, company matching of charitable contributions, profit sharing and is eligible for paid time off.

Please note that the salary information is a general guideline only. Other factors such as (but not limited to) scope and responsibilities of the position, candidate's work experience, education/ training, key skills as well as market and business considerations when extending an offer.

Qualifications

Must have excellent planning skills, be highly organized and detail oriented, able to manage multiple projects simultaneously and be able to adapt to changing environments and priorities. Must be a self-starter with the ability to work productively and meet benchmarks and goals in a timely fashion. Strong interpersonal communication and organizational skills are required. Experience in consulting firms strongly preferred. Project Management Professional (PMP) certification is preferred.

Requirements

• Bachelor of Science Degree in Engineering, science, or closely related discipline
• 5+ years of experience in a Project Management capacity
• 3+ years of experience managing > $5MM capital projects within the Pharmaceutical, Biotech, and/or Life Sciences industries (ATMP Preferred) and working knowledge of cGMP compliance
• Experience in consulting firms preferred.
• Experience in pharmaceutical, biotech or other life science industries required
• Knowledge of FDA, EMA, and other pharmaceutical regulatory standards and requirements
• Knowledge and application of ISPE Baseline Guides
• Knowledge and application of ASME BPE
• Must be comfortable working remotely
• Proficient in project scheduling tool
  
• Proficient in project controls tools and software
• Proficient in spreadsheet and word process software is required. Google Suite knowledge preferred.
• Excellent verbal, written and presentation skills
• Ability to communicate and work with staff at all levels
• Able to work in the US without sponsorship now or any time or in the future
• Ability to lead a small-to medium project entirely or area of a large project
  

Essential Functions and Responsibilities

• Overall scope, schedule, budget and risk management against contracts
• Cost and schedule development and estimating
• Leading the generation of draft proposals in response to client RFPs for PM review. Examples include, but not limited to, Project Execution Plans (PEPs), Staffing Plan, Schedule, Cost Estimate and Earned Value Tracking Tools
• Oversight, coordination and execution of capital and maintenance projects from inception to turnover to user groups, including project scoping, preliminary and detailed design and review, CAPEX document development and approval, construction/installation, commissioning, startup and qualification
• Design oversight and compliance with industry practices and guidelines
• Management and successful execution of projects using cGMPnow standard tools and templates, client procedures and industry best practices to the upon scope, schedule, budget and technical quality
• Coordinate all technical activities on assigned projects. Responsible for having an awareness of and ability to recognize technical problems.
• Oversight of design packages and specifications, RFPs, design review, vendor/contractor selection, constructability reviews, approval of submittals, and preparation and oversight of validation and regulatory submissions
• Monitors project budgets and schedules for trends/compliance to budget and prepare periodic reports
• Coordinate reviews and checking of engineering deliverables
• Coordinate the efforts of engineering support groups and external resources such as, consultants and contractors
• Conduct project meetings with user group and project stakeholders
• Prepare detailed project cost estimates and schedules
• Oversight of engineering calculations and analysis related to process design and equipment selections
• Define project scope and develop preliminary engineering drawings such as layouts, P&IDs and PFDs
• Traveling as required for client development and project execution
  

Skills

• Team player, hands-on attitude, willingness to be actively involved
• Hard working, driven, results-oriented and focused on success
• High ethical standards and integrity
• Ability to perform work with little to no direction
• Proficient in project management software or systems is preferred
• Effective oral and written communication
• Customer service including attentive and active listening with management, employees, vendors and customers
• Critical thinking and problem solving
• Time management, organizational and planning processes
  

Knowledge

• Operating standard office equipment including; personal computers, peripherals, and typical office equipment (telephone, copier, printers, scanners, etc.)
• Integrated financial management systems
• Microsoft Office Suite (Word, Outlook, PowerPoint, Excel) and other related software programs
  

Abilities

• Manage multiple priorities and multi-task with frequent interruptions
• Flexible in times of change and adapt to changing environments and priorities
• Take initiative and plan ahead
  
• Maintain a good attitude while working under pressure and defuse stressful situations while contributing to a positive and productive team atmosphere
• Work in a team environment and work effectively with other departments to accomplish goals
• Work independently with little or no supervision
• Plan, conduct and attend meetings in person or via teleconference software
  

Other

• Willingness to travel locally, within 60 miles of residence, for full time support at client site
• Willingness to travel outside of local area up to 30% of the time over a calendar year
• All other duties as assigned
  

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