cGMPnow · 2 days ago
Associate Director Professional Service Operations for Front-End Engineering Design (FEED)
United States
Full-time
Remote
Lead/Staff, Director/Executive
$205K/yr - $245K/yr
10+ years expcGMPnow is a company that accelerates Next Generation Therapies to patients by providing GxP Manufacturing & QC Laboratory Equipment and related services. The Associate Director Professional Service Operations for Front-End Engineering Design (FEED) is responsible for delivering and overseeing early-phase engineering for GMP manufacturing and life-science facility projects while leading multidisciplinary teams and ensuring technical quality.
BiotechnologyManufacturingPharmaceutical
No H1B
Responsibilities
Lead and mentor FEED engineers, process engineers, architects, and cross-functional SMEs across multiple active projects
Oversee resource planning, task delegation, quality control, technical reviews, and schedule adherence
Provide guidance on engineering methods, regulatory alignment, and best practices for conceptual design
Support staff development through coaching, knowledge-sharing, and performance oversight
Serve as a primary point of contact for clients during the FEED phase, ensuring clear communication, alignment, and expectation-setting
Facilitate user requirement workshops, executive presentations, and decision-making sessions
Build strong relationships with client technical leads, capital project leadership, and site functional teams
Lead the Front End Engineering Design (FEED) efforts on select projects: GMP Site Selection / Due Diligence, Capital Project Scoping / Business Case Development / Portfolio Planning, GMP MFG Make vs Buy Assessments, GMP MFG Facility Concept Design / Feasibility Studies (with cost/schedule estimates), CDMO Assessment/Selection Support, EU Annex 1 Facility Gap Assessments
Conduct feasibility studies, option analyses, and process/facility fit assessments for new or renovated GMP spaces
Lead development of BOD, URS, design criteria, conceptual layouts, PFDs, flow diagrams, and preliminary architectural/process designs
Define bioprocess requirements (e.g., upstream, downstream, viral, ATMP, fill-finish, HPAPI/ADC, lab spaces) and translate them into facility and utility concepts
Drive containment strategy definition (OEB/OEL), biosafety classifications, pressure cascades, and contamination control concepts
Develop or support the development of technical, cost, and schedule details of proposals based upon handoff from Business Development
Generating or supporting the generation of detailed proposals in response to client RFPs that, at a minimum, include the following supporting documents: Staffing Plan, Schedule and Cost Estimate (Deliverable Based and/or Level of Effort)
Lead or support the project manager in establishment of all tools needed for the project: Project Execution Plan (PEP), Schedule, Committed Cost Report (CCR), Plan vs Actual Spend Chart, Earned Value Tracking Chart, Scope of Work (SOW), Monthly Status Report, Master Equipment List, Project Requirements Specification (PRS)
Ensure project deliverables and execution are aligned to client expectations
Serve as the “keeper of the concept” during early detailed design, ensuring continuity and intent are preserved
Support client decisions, scope alignment, and change management as the project evolves
Lead development of early ROM cost estimates (±30–50%) and capital planning packages
Build milestone schedules across design, procurement, construction, Cx/CQV, and PQ readiness
Identify key long-lead equipment and procurement risks during concept stages
Present capital planning recommendations to client executives and steering committees
Direct the integration of mechanical, electrical, plumbing, process utilities, automation/IT/OT, architectural, and CQV conceptual scopes
Build or lead development of preliminary equipment lists, specifications, and vendor evaluation packages
Ensure FEED concepts align with downstream engineering, construction sequencing, and commissioning strategies
Oversee technical quality and completeness of all FEED deliverables across project teams
Conduct formal design reviews and ensure consistency with corporate templates, standards, and engineering best practices
Ensure FEED deliverables align with FDA, EMA, EU Annex 1, ICH, ISPE Baseline Guides, and current GMP expectations
Apply risk-based methodologies (FMEA, contamination control, process risk assessments) to shape front-end decisions
Define high-level validation, commissioning, automation, and data-integrity strategy
Support Human Resources during the five employee life cycle phases for PSO workstream staff: recruiting, hiring, onboarding, employee engagement and separation of employment
Provide supervision and management of Professional Service Operations workstream staff
Conduct 1:1’s with PSO staff and support Human Resources during annual performance reviews
Mentor and provide professional development guidance for the Professional Service Operations workstream staff
Develop and maintain best practices for Project Management & Engineering Design execution
Oversee the Professional Service Operations execution across the cGMPnow portfolio of projects to ensure alignment with best practices
Seek to improve overall execution strategy and skills of the Professional Service Operations workstream
Support continuous improvement of FEED tools, templates, workflows, and knowledge management
Manage and/or support the allocation of all resources across the portfolio of projects to align to with productivity targets established by the COO
Conduct or provide support to regularly occurring Professional Service Operations resource management meetings and the associated Professional Service Operations Resource Tracking Tool for tracking of employees and partner/subcontractor involvement on active projects
Identify upcoming resource needs to Human Resources and support recruiting and hiring efforts
Qualification
Required
Bachelor's degree in Chemical, Mechanical, Bioengineering, Architecture, or related engineering discipline
10–20+ years of experience in FEED for GMP life-science environments
Demonstrated experience (7+ years) leading project teams, managing clients, and overseeing the development of large capital project FEED packages
Strong working knowledge of GMP bioprocessing, advanced therapeutics, ADC/HPAPI, sterile operations, or other regulated modalities
Familiar with ASME BPE, ISPE Baseline Guides, EU/FDA regulations, cGMPs, and risk-based design methodologies
Excellent leadership, communication, and client-facing skills; able to influence decision-making at senior levels
Experience with AutoCAD, Revit, 3D modeling is required
Supervisory and Management experience of resources
Professional Service (engineering/consulting) firm experience
Able to work in the US without sponsorship now or any time or in the future
Preferred
Process simulation tools experience is preferred
Benefits
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
Eligible for paid time off
Company
cGMPnow
cGMPnow is a pharmaceutical manufacturing company that produces and distributes gene and cell therapy products for medical use.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Jeff Gilmore
Chief Executive Officer
Recent News
2025-05-27
Company data provided by crunchbase