cGMPnow

Compensation

Full Description

TITLE: Associate Director Professional Service Operations for Front-End Engineering Design (FEED) DEPARTMENT: Operations REPORTS TO: Chief Operations Officer (COO) CLASSIFICATION: Exempt (salary) STATUS: Full Time LOCATION: Varies Between Remote, at a Client Site in the US and at an office cGMPnow accelerates Next Generation Therapies to patients by providing GxP Manufacturing & QC Laboratory Equipment, GxP Computerized Systems, Commissioning & Qualification, and Procurement services using project-dedicated expert resources. 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 Associate Director Professional Service Operations for Front-End Engineering Design (FEED) is a senior technical leader responsible for delivering and overseeing early-phase engineering for GMP manufacturing and life-science facility projects. This role is both hands-on and leadership-oriented: the Associate Director performs complex FEED work themselves while directing multidisciplinary teams, managing project execution, ensuring technical quality, and serving as a primary client-facing representative. The position establishes the conceptual, technical, regulatory, and financial foundations that shape major capital projects—enabling seamless transition into detailed design, procurement, construction, and qualification. COMPENSATION & BENEFITS: Salary Compensation Range: $205,000 - $245,000 annual depending on years of relevant experience 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. 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. REQUIREMENTS: • 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 • Process simulation tools experience is preferred. • 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 ESSENTIAL TECHNICAL FUNCTIONS and RESPONSIBILITIES: LEADERSHIP and TEAM MANAGEMENT • 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. CLIENT and STAKEHOLDER MANAGEMENT • 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. FRONT-END ENGINEERING and CONCEPT DEVELOPMENT (HANDS-ON EXECUTION) • 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. TECHNICAL DESIGN COORDINATION • 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. QUALITY ASSURANCE, REGULATORY and COMPLIANCE LEADERSHIP • 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. ESSENTIAL RESPONSIBILITIES: SUPERVISOR and MANAGER of PSO STAFF • 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. QUALITY CONTROL and CONTINUOUS IMPROVEMENT • 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. PROFESSIONAL SERVICES OPS RESOURCE 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. 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 • Excellent oral and written communication • Personal computer and keyboarding • Critical thinking and problem solving • Time management, organizational and planning processes • Proficiency in staff management • Leadership & team development • Conceptual design excellence • GMP regulatory knowledge • Risk-based engineering decision-making • Client management & executive communication - Exemplary Customer service including attentive and active listening with management, employees, vendors and customers • Cross-disciplinary coordination • Capital cost & schedule planning • High-level strategic planning • Quality oversight & governance KNOWLEDGE: • Operating standard office equipment including; personal computers, peripherals, and typical office equipment (telephone, copier, printers, scanners, etc.) • Microsoft Office Suite (Word, Outlook, PowerPoint, Excel) and other related software programs • Google Suite proficient ABILITIES: • Highly skilled in managing multiple priorities and multi-tasking with frequent interruptions • Extremely flexible in times of change and can easily 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 effectively and collaboratively with Directors of other workstreams • Works effectively with Officers of the company • Work independently with little or no supervision • Plan, conduct and attend meetings in person or via teleconference software 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 30% 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. Job Type: Full-time Pay: $205,000.00 - $245,000.00 per year Benefits: • 401(k) • 401(k) matching • Dental insurance • Health insurance • Life insurance • Paid time off • Vision insurance Application Question(s): • When are you available to start a new position? • Enter your email address • LinkedIn URL • Who is your current employer and occupation? • Please indicate your salary or hourly requirements • What is your home location? • Are you willing to travel up to 30% of the time over a calendar year? • Why are you seeking a new position with cGMPnow? • For project placement planning: For the the year following your start date, what significant time off (> 2 weeks) might you need? • Indicate Yes or No if you meet the following three requirements: 1) Bachelor of Science Degree in Engineering, science, or closely related discipline, 2) 5+ years of experience in a Project Management capacity 3) 3+ years of experience managing > $5MM capital projects within the Pharmaceutical, Biotech, and/or Life Sciences industries (ATMP Preferred) and working knowledge of cGMP compliance Experience: • Project management: 5 years (Preferred) Work Location: Remote