Job Overview
Employment Type
Full-time
Compensation
Salary
Range $150,000.00 - $200,000.00
Benefits
401(k)
401(k) matching
Dental Insurance
Health Insurance
Life insurance
Paid Time Off
Vision Insurance
Job Description
cGMPnow is a renowned company specializing in accelerating next-generation therapies to patients by providing a comprehensive suite of GxP Manufacturing and Quality Control (QC) Laboratory Equipment, GxP Computerized Systems, Commissioning and Qualification, and Procurement services. With a unique project delivery methodology and owner-focused involvement, cGMPnow is dedicated to bringing innovative products to the market faster by delivering cGMP systems with enhanced efficiency and quality. Operating within the highly regulated environments governed by the FDA and EU standards, cGMPnow serves clients in the pharmaceutical, biotech, and life sciences industries, particularly within the realm of advanced therapeutics. The company is committed to excellence, regulatory compliance, and customer success, making it a leader in its sector.
The Project Manager (PM) role at cGMPnow is a critical position within the Professional Service Operations department, reporting directly to the Director of Project Management. This full-time, exempt position offers a hybrid work location, primarily in the San Diego County, CA area, balancing remote work with on-site presence at multiple client locations. The Project Manager is pivotal in managing the overall scope, schedule, and budget of CAPEX and cGMP-compliance projects, ensuring alignment with regulatory standards and client expectations. With a salary range of $150,000 to $200,000 annually plus commission potential of up to $50,000 or more, this role comes with significant professional development opportunities and a comprehensive benefits package including healthcare with premiums fully paid by the employer, retirement plan contributions, paid time off, and other perks.
In this role, the Project Manager will be responsible for planning and coordinating all aspects of project execution within the FDA and EU regulated advanced therapeutic industries. This includes managing project resources, designing budgets, monitoring progress, and maintaining transparent communication with stakeholders throughout the project life cycle. The PM must be adept at navigating dynamic project environments, advocating for client success, and ensuring that all deliverables comply with rigorous cGMP standards. Experienced candidates who thrive in consulting firms or dynamic project management roles will find this position rewarding as it requires exceptional organizational skills, leadership in cross-functional team environments, and the ability to manage multiple complex projects simultaneously.
The successful candidate will have extensive experience in GMP-regulated industries, especially in managing CAPEX and operational readiness projects related to pharmaceuticals, biotechnology, and life sciences. This position requires a deep understanding of FDA, EMA, and other pharmaceutical regulatory requirements, as well as proficiency with project controls, scheduling tools, and the management of multidisciplinary teams including engineers, contractors, and validation specialists. Strong communication skills and the ability to foster consensus among stakeholders at all organizational levels are essential. This role not only demands technical expertise but also critical thinking, time management, and problem-solving abilities, paired with a hands-on attitude and commitment to high ethical standards.
Overall, the Project Manager role at cGMPnow offers a unique blend of technical challenge, regulatory compliance focus, and client-facing responsibilities that make it an excellent opportunity for seasoned project managers seeking to make a significant impact in the advanced therapeutic sector. With a supportive and inclusive workplace, competitive compensation, and opportunities for continuous learning and growth, this position stands out as a premier career choice within the life sciences project management landscape.
The Project Manager (PM) role at cGMPnow is a critical position within the Professional Service Operations department, reporting directly to the Director of Project Management. This full-time, exempt position offers a hybrid work location, primarily in the San Diego County, CA area, balancing remote work with on-site presence at multiple client locations. The Project Manager is pivotal in managing the overall scope, schedule, and budget of CAPEX and cGMP-compliance projects, ensuring alignment with regulatory standards and client expectations. With a salary range of $150,000 to $200,000 annually plus commission potential of up to $50,000 or more, this role comes with significant professional development opportunities and a comprehensive benefits package including healthcare with premiums fully paid by the employer, retirement plan contributions, paid time off, and other perks.
In this role, the Project Manager will be responsible for planning and coordinating all aspects of project execution within the FDA and EU regulated advanced therapeutic industries. This includes managing project resources, designing budgets, monitoring progress, and maintaining transparent communication with stakeholders throughout the project life cycle. The PM must be adept at navigating dynamic project environments, advocating for client success, and ensuring that all deliverables comply with rigorous cGMP standards. Experienced candidates who thrive in consulting firms or dynamic project management roles will find this position rewarding as it requires exceptional organizational skills, leadership in cross-functional team environments, and the ability to manage multiple complex projects simultaneously.
The successful candidate will have extensive experience in GMP-regulated industries, especially in managing CAPEX and operational readiness projects related to pharmaceuticals, biotechnology, and life sciences. This position requires a deep understanding of FDA, EMA, and other pharmaceutical regulatory requirements, as well as proficiency with project controls, scheduling tools, and the management of multidisciplinary teams including engineers, contractors, and validation specialists. Strong communication skills and the ability to foster consensus among stakeholders at all organizational levels are essential. This role not only demands technical expertise but also critical thinking, time management, and problem-solving abilities, paired with a hands-on attitude and commitment to high ethical standards.
Overall, the Project Manager role at cGMPnow offers a unique blend of technical challenge, regulatory compliance focus, and client-facing responsibilities that make it an excellent opportunity for seasoned project managers seeking to make a significant impact in the advanced therapeutic sector. With a supportive and inclusive workplace, competitive compensation, and opportunities for continuous learning and growth, this position stands out as a premier career choice within the life sciences project management landscape.
Job 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
Job Qualifications
- must have excellent planning skills
- be highly organized and detail oriented
- able to manage multiple projects simultaneously
- able to adapt to changing environments and priorities
- be a self-starter
- strong interpersonal communication and organizational skills
- experience in consulting firms strongly preferred
- project management professional (PMP) certification preferred
- 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
Job Duties
- lead business process mapping sessions with site stakeholders to create roadmaps to CAPEX project solutions for personnel, equipment, facility, data, and quality
- manage architect/engineer, design-build, design-assist, general contractor and commissioning and qualification teams throughout project execution
- direct construction administration processes with engineer of record including RFIs, submittals, change orders, field observations, punch lists, turnover packages, and closeout documentation
- apply knowledge and experience of facility programming, space planning, GMP material/personnel flows, cleanroom design principals, and operational requirements
- predict, plan and resolve common design decisions that balance operational, quality, regulatory, schedule, budget, and constructability considerations
- responsible for overall scope, schedule, budget and risk management against contracts
- lead formal design review workshops at conceptual, basis of design, 30%, 60%, 90%, IFC, and construction phases
- lead the process, tracking and controls for generation of project management documentation including project execution plans (PEPs), staffing plan, schedule, cost estimate and earned value tracking tools
Job Criteria
Experience
Expert Level (7+ years)
Job Location
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