Project Manager

About the Company

TITLE: Project Manager

DEPARTMENT: Professional Service Operations

REPORTS TO: Director of Project Management

CLASSIFICATION: Exempt (salary)

STATUS: Full Time

LOCATION: Varies Between Remote at multiple client sites in the greater Indianapolis, IN area

cGMPnow accelerates Next Generation Therapies to patients by providing GxP Manufacturing & QC Laboratory Equipment, GxP Computerized Systems, Commissioning & Qualification, and Procurement services With our unique project delivery methodology and owner-focused involvement, we bring new products to the market faster by providing cGMP systems faster.

About the Role

POSITION SUMMARY: The Project Manager (PM) is responsible for overall management of scope, schedule, and budget on CAPEX and cGMP-compliance projects to FDA & EU regulated Advanced Therapeutic industries. This role is responsible for planning and overseeing projects to ensure they are completed in a timely fashion and within budget managing project delivery by closely aligning with client stakeholders and advocating for their project success. 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 - $200,000 annual
• Commission Potential Compensation Range: $0 - $50,000+ annual
• This position is eligible for healthcare benefits with the employee 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.
• Training, conferences and professional registration dues are eligible for reimbursement.
• 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.

REQUIREd SKILLS:

• Bachelor of Science Degree in Engineering, science, or closely related discipline
• 10+ years total experience in GMP-regulated industry leading client-side project execution as a CAPEX Project Manager, Design Manager, Construction Manager, or similar role.
• 5+ years of experience managing CAPEX, cGMP-compliance and/or Operational Readiness projects within the Pharmaceutical, Biotech, and/or Life Sciences industries (Advanced Therapeutics Preferred)
• Experience with managing A/E firms, EPCM firms, General Contractors and Commissioning & Qualification contractors
• Experience with design management and governance
• Experience leading Design review
• Experience with construction administration and field oversight
• Experience with cross-functional stakeholder alignment
• Experience with consensus building and decision-making related to facility operations GMP compliance, and user requirements
• Experience with design-to-execute-to-turnover continuity
• Working knowledge of cGMP compliance
• Strong knowledge of FDA, EMA, and other pharmaceutical regulatory standards and requirements
• Must be comfortable working in Client facilities and remotely
• Proficient in project scheduling tools
• Proficient in project controls tools and software
• Proficient in Google Suite spreadsheet and word processing software
• Demonstrated 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

ESSENTIAL FUNCTIONS & RESPONSIBILITIES

• Lead business process mapping sessions with site stakeholders to create roadmaps to CAPEX project solutions for personnel, equipment, facility, data, and quality.
• Manages Architect/Engineer, Design-Build, Design-Assist, General Contractor and Commissioning and Qualification teams througho…