TITLE: Senior Project Manager
DEPARTMENT: Professional Service Operations
REPORTS TO: Director Project Management
CLASSIFICATION: Exempt (salary)
STATUS: Full Time
LOCATION: Varies between Remote and/or at a Client Site in the US
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.
POSITION SUMMARY:
The Senior 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. 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: $190,000 - $240,000 annual depending on years of relevant experience
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.
REQUIREMENTS:
Must have excellent planning skills, be highly organized and detail oriented, able to support multiple projects simultaneously and 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.
- Bachelor of Science Degree in Engineering, science, or closely related discipline
- 11+ years total experience in GMP-regulated industry
- 8+ years of experience in a Project Management capacity
- 3+ years of experience managing CAPEX, cGMP-compliance and/or Operational Readiness projects within the Pharmaceutical, Biotech, and/or Life Sciences industries (ATMP Preferred) and 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 and RESPONSIBILITIES:
- Ability to lead business process mapping sessions with site stakeholders to create roadmaps to CAPEX project solutions and Operational Readiness for personnel, equipment, facility, data, and quality.
- Experience predicting, planning or, and/or resolving common CAPEX project and operational readiness issues
- Overall scope, schedule, budget and risk management against contracts
- Cost and schedule development and estimating
- Leading the generation of project management documentation. Examples include, but not limited to, Project Execution Plans (PEPs), Staffing Plan, Schedule, Cost Estimate and Earned Value Tracking Tools
- Reporting progress against deliverables and earned value using cost performance index CPI
- Oversight, coordination and execution of CAPEX and Operational Readiness projects from inception to turnover to user groups, including project scoping, preliminary and detailed design and review, CAPEX/OPEX 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 agreed 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 vendors, 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:
- Strong candidate will possess the following key attributes:
- 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
- Experience in consulting firms preferred
- Knowledge and application of ISPE Baseline Guides
- Excellent verbal, written and presentation skills
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
- Google Suite proficient
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
- 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 - arriving early, and posting minutes promptly
- Understands the business needs of the company and has a thorough knowledge of the end customer needs when developing a project scope
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 25% of the time over a calendar year
- All other duties as assigned
PHYSICAL REQUIREMENTS:
The position requires intermittent physical activity of sitting, standing, walking, bending, stooping, crouching and lifting up to 25 pounds on occasion. If you cannot do one of these physical requirements cGMPnow will make reasonable accommodations. Must be able to talk, write and understand the English language. Able to type/keyboard or enter data using a computer up to 8 hours per day. Must possess normal manual dexterity and eye-hand coordination.
cGMPnow is an Equal Opportunity Employer and Prohibits Discrimination and Harassment of Any Kind: cGMPnow is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, family or parental status, or any other status of a protected class by the laws or regulations in the locations where we operate. cGMPnow will not tolerate discrimination or harassment based on any of these characteristics.
The term “protected class” refers to groups of people who are legally protected from being harmed or harassed by laws, practices, and policies that discriminate against them due to a shared characteristic (e.g. race, gender, age, disability, or sexual orientation).
The preceding job description has been designed to indicate the general nature and level of work performed by the employee(s) within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees in this position. Job descriptions are not intended as and do not create employment contacts. The organization maintains its status as an at-will employer.
Pay: $190,000.00 - $240,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Work Location: Remote
