Talantix.io
Aurion Biotech•04.03.26
AI SCORE 8.5

Senior CMC Project Manager - Remote

$120K–$150K/year
RemoteBiotechnology
Project Management•Regulatory Compliance•Quality Assurance•CMC•Agile•Stakeholder Management•Microsoft Office•Smartsheet

About the Role

We are seeking a Senior CMC Project Manager - Remote to lead our cross-functional teams in the biotechnology sector. In this role, you will be instrumental in managing the chemistry, manufacturing, and controls (CMC) aspects of our projects, ensuring compliance with regulatory standards and driving project success.

What You'll Do

  • Oversee the CMC project lifecycle from initiation to completion, ensuring alignment with strategic goals.
  • Collaborate with cross-functional teams to develop and implement project plans, timelines, and budgets.
  • Manage stakeholder communications and expectations, providing regular updates on project progress.
  • Ensure compliance with CGMP and quality assurance standards throughout the project.
  • Utilize project management tools such as Smartsheet and SharePoint to track project milestones and deliverables.
  • Conduct risk assessments and develop mitigation strategies to address potential project challenges.
  • Lead meetings and presentations to communicate project status and outcomes to senior management.
  • Mentor junior project managers and support their professional development.

Requirements

  • Minimum of 5 years of experience in project management within the biotechnology or pharmaceutical industry.
  • Proven track record of managing CMC projects successfully.
  • Strong understanding of regulatory compliance, quality management systems, and clinical development processes.
  • Excellent communication and interpersonal skills for effective stakeholder management.
  • PMP certification is highly desirable.
  • Experience with Agile methodologies and cross-functional team leadership.
  • Proficiency in Microsoft Office Suite and project management software.
  • Ability to work independently and manage multiple projects simultaneously.

Nice to Have

  • Experience in ophthalmology or clinical affairs.
  • Knowledge of drug discovery processes and new product introduction (NPI) programs.
  • Familiarity with mobility software solutions.

What We Offer

  • Full health insurance for employees and their families.
  • 401(k) matching and generous paid time off (PTO).
  • Competitive compensation packages.
  • Paid parking and subsidized commuter passes.
  • In-office catered lunches and team events.
  • Flexible remote work environment.
Why This Job8.5 of 10

This Senior CMC Project Manager role offers a unique opportunity to lead critical projects in the biotechnology field while enjoying a flexible remote work environment and competitive benefits.

Salary Range
Required
0/1
Optional
0/1
Bonus
0/1

Who Will Succeed Here

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Proficient in CMC regulations and methodologies, with hands-on experience in managing projects that require a deep understanding of both chemistry and manufacturing processes, ensuring compliance with FDA and EMA standards.

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Demonstrates strong organizational skills and adaptability in a remote work environment, effectively utilizing tools like Smartsheet for project tracking and Microsoft Office for reporting and presentations to keep stakeholders informed.

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Possesses a strategic mindset with a proven track record in Agile project management, enabling the ability to pivot quickly and manage cross-functional teams while aligning project goals with regulatory compliance.

Learning Resources

→Project Management Basics for Beginnerscourse
→Regulatory Compliance in the Biotech Industrycourse
→Quality Assurance in Biotech: A Comprehensive Guidearticle

Career Path

Senior CMC Project Manager - Remote(Now)→Director of CMC Operations(2-4 years)→Vice President of Project Management(5-7 years)

Market Overview

Market Size 2024
$29.5B
Annual Growth
12.3%
AI Adoption in Project Management
45%
Investment in Project Management Tools
+35%
Labour Demand for Project Managers
+20%
Avg Salary for Senior Project Managers
$120K

Skills & Requirements

Required
Project ManagementRegulatory ComplianceQuality Assurance
Growing in Demand
Agile MethodologiesData AnalyticsChange Management
Declining
Waterfall Project ManagementTraditional Gantt Charts

Domain Trends

Increased Use of AI in Project Management
By 2025, 60% of project managers will be using AI tools to enhance productivity and decision-making.
Shift to Remote Project Management
Over 70% of organizations are now adopting remote project management practices, leading to increased demand for remote project managers.
Focus on Regulatory Compliance and Quality Assurance
80% of technology projects are prioritizing regulatory compliance and quality assurance, reflecting the growing importance of these areas in project management.

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