Project Manager
TITLE: Project Manager
DEPARTMENT: Professional Service Operations
REPORTS TO: Director of Project Management
CLASSIFICATION: Exempt (salary)
STATUS: Full Time
LOCATION: Varies Between Remote or at a Client Site in the San Diego, CA 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.
POSITION SUMMARY:
The Project Manager (PM) is responsible for the overall management of scope, schedule, and budget on CAPEX and cGMP-compliance projects to FDA & EU regulated Advanced Therapeutic industries. Beyond core project management duties—such as resource planning, budget preparation, and progress monitoring—the PM provides comprehensive engineering oversight throughout the project lifecycle. This includes guiding process design, from developing mass balances and equipment lists to drafting process flow diagrams (PFDs), P&IDs, and User Requirement Specifications (URS). The PM actively drives process equipment specification, factory and site acceptance testing (FAT/SAT), installation, and commissioning, ensuring all engineering deliverables are fully coordinated, technically sound, and executed within budget.Ultimately, the PM 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.
REQUIREMENTS:
Bachelor of Science Degree in Chemical, Biological, Biopharmaceutical or similar engineering degree required
5+ years total project management experience in GMP-regulated industry
3+ years of experience managing CAPEX, cGMP-compliance and/or Operational Readiness projects within the Pharmaceutical, Biotech, and/or Life Sciences industries (ATMP Preferred)
3+ years experience in process design within the Pharmaceutical, Biotech, and/or Life Sciences industries (ATMP Preferred)
Working knowledge of cGMP compliance
Strong knowledge of FDA, EMA, and other pharmaceutical regulatory standards and requirements
Experience working in pharmaceutical or biologics manufacturing facilities preferred
Experience in consulting firms preferred
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
Support management of RFPs and approval of submittals
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
Business Development
Supporting 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
Sharing with project PM potential opportunities observed for marketing services to clients and consistently maintain client contact
Support preparation of detailed project cost estimates and schedules
Author proposals for small to medium sized projects (<$1M)
Lead team efforts to develop large proposals ($1M+)
Verify proposal alignment to cGMPnow Business Plan and brand
Document status of proposals in the proprietary cGMPnow RFP Log system
Engineering
Supporting gathering process data and developing project requirements
Supporting the development of mass balances and constructing detailed equipment lists for complex cGMP manufacturing and laboratory equipment
Supporting the developing process description narratives, process flow diagrams (PFDs), P&IDs, User Requirement Specification (URS) documents
Working directly with facilities, manufacturing, technical operations, and facility planners to layout the process needs including equipment, space, adjacencies, and flows
Researching process equipment providers and making recommendations/selections based on project requirements
Supporting process equipment specifications for complex cGMP manufacturing and lab equipment
Supporting testing requirements and attending factory acceptance tests (FATs) for equipment
Performing receipt verification of manufacturing, lab and process utility equipment.
Specifying and coordinating installation, startup and commissioning services by vendors or 3rd parties for manufacturing, lab and process utility equipment.
Supporting writing and updating SOPs as required for new process and project implementations
Supporting projects after construction documents are issued, reviewing submittals, answering RFIs, and field verifying progression of process scope is proceeding per the intent of the design
Supporting activities of Engineering, CAD and Designer support staff
Staying abreast of the latest technologies used in our industry and being aware of the approximate costs of the various technologies that could be used to solve our clients' design challenges
Working with the client and discipline leads to ensure engineering deliverables and all the necessary details related to the process are delivered on time, fully coordinated, and within the project budget
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).
Disclaimer:
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.
