TITLE: Project Manager

DEPARTMENT: Professional Service Operations

REPORTS TO: Director of Project Management

CLASSIFICATION: Exempt (salary)

STATUS: Full Time

LOCATION: Varies Between Remote and at multiple client sites 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 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.

REQUIREMENTS:

• 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 and 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 throughout project execution.
• Directs construction administration processes with engineer of record including RFI’s, submittals, change orders, field observations, punch lists, turnover packages, and closeout documentation.
• Applies knowledge and experience of facility programming, space planning, GMP material/personnel flows, cleanroom design principals, and operational requirements.
• Predicts, plans and resolves common design decisions that balance operational, quality, regulatory, schedule, budget, and constructability considerations.
• Responsible for overall scope, schedule, budget and risk management against contracts
• Leads formal design review workshops at Conceptual, Basis of Design, 30%, 60%, 90%, IFC, and construction phases.
• Leads the process, tracking and controls for 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
• Reports progress against deliverables and earned value using cost performance index CPI
• Manages the 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
• Provides 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
• Coordinates reviews and checking of engineering deliverables
• Coordinates the efforts of engineering support groups and external resources such as vendors, consultants and contractors
• Conducts project meetings with user group and project stakeholders
• Prepares detailed project cost estimates and schedules
• Travels as required for client development and project execution
• Supports project closeout activities including punch list management, turnover documentation review, as-built documentation verification, and lessons learned sessions.

Business Development

• Supports 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
• Shares with project PM potential opportunities observed for marketing services to clients and consistently maintain client contact
• Supports preparation of detailed project cost estimates and schedules
• Authors proposals for small to medium sized projects (<$1M)
• Leads team efforts to develop large proposals ($1M+)
• Verifies proposal alignment to cGMPnow Business Plan and brand
• Documents status of proposals in the proprietary cGMPnow RFP Log system

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, written communication and presentation skills
• Customer service including attentive and active listening with management, employees, vendors and customers
• Understanding of facility lifecycle management from concept development through operations and maintenance.
• Critical thinking and problem solving
• Time management, organizational and planning processes
• Experience in consulting firms preferred

KNOWLEDGE:

• Familiarity with BIM coordination processes, reviews, and design collaboration platforms preferred.
• 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, MS Project) 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).

Pay: $150,000.00 - $200,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Work Location: Hybrid remote in San Diego County, CA