Senior Manager / Associate Director, CMC Project Management

About the role

Bamboohr is seeking a highly skilled and motivated Senior Manager or Associate Director for our CMC (Chemistry, Manufacturing, and Controls) Project Management team. This position is pivotal in overseeing the development and execution of our CMC strategies, ensuring that our innovative therapies are brought to market efficiently and effectively. The ideal candidate will have a strong background in project management within the biopharmaceutical industry and will be instrumental in driving cross-functional collaboration to meet project milestones and regulatory requirements.

Key facts

What you'll do

• Lead and manage CMC project teams, ensuring alignment with corporate goals and timelines while fostering a collaborative environment.
• Develop and implement project plans, including timelines, budgets, and resource allocation, to ensure successful execution of CMC activities.
• Coordinate with various departments, including R&D, regulatory affairs, quality assurance, and manufacturing, to facilitate seamless project progression.
• Monitor project performance and progress, identifying risks and implementing mitigation strategies to address potential issues proactively.
• Prepare and present project updates to senior management and stakeholders, ensuring transparency and effective communication throughout the project lifecycle.
• Ensure compliance with regulatory requirements and industry standards, maintaining a thorough understanding of CMC-related regulations.
• Collaborate with external partners and vendors, managing relationships to ensure that project deliverables are met on time and within budget.
• Mentor and develop junior project management staff, providing guidance and support to enhance their skills and career growth.
• Drive continuous improvement initiatives within the CMC project management function, identifying areas for efficiency and effectiveness enhancements.
• Participate in the development of strategic plans for CMC operations, contributing insights based on project experiences and industry trends.
• Facilitate cross-functional meetings and workshops to promote knowledge sharing and foster a culture of innovation within the team.
• Act as a key point of contact for project-related inquiries, ensuring that all stakeholders are informed and engaged throughout the project lifecycle.

Requirements

• A minimum of 7 years of experience in project management within the biopharmaceutical or biotechnology industry, with a focus on CMC activities.
• Proven track record of successfully managing complex projects from inception to completion, demonstrating strong organizational and leadership skills.
• In-depth knowledge of CMC processes, regulatory requirements, and industry best practices.
• Excellent communication skills, both verbal and written, with the ability to convey complex information clearly to diverse audiences.
• Strong analytical and problem-solving abilities, with a keen attention to detail and a proactive approach to risk management.
• Experience working in cross-functional teams and managing relationships with external partners and stakeholders.
• Proficiency in project management tools and software, with a strong understanding of data analysis and reporting.
• A bachelor's degree in a relevant scientific or engineering discipline; an advanced degree (MS or PhD) is preferred.
• PMP certification or equivalent project management qualification is a plus.

Nice to have

• Experience in gene therapy or cell therapy development is highly desirable.
• Familiarity with quality systems and regulatory compliance in a GMP environment.
• Previous experience in a start-up or fast-paced environment, demonstrating adaptability and resilience.
• Knowledge of digital project management tools and methodologies.
• Strong network within the biopharmaceutical industry, with established relationships with regulatory agencies.

Skills & tools

• Project management software (e.g., Microsoft Project, Asana, or similar)
• Data analysis tools (e.g., Excel, Tableau)
• Regulatory compliance knowledge (FDA, EMA guidelines)
• Excellent interpersonal skills for effective team collaboration
• Strong presentation skills for stakeholder engagement

Practical notes

• This position is based in San Diego, California, and may require occasional travel to partner sites or conferences.
• The salary for this role will be competitive and commensurate with experience, including benefits and potential bonuses.
• Bamboohr is committed to fostering a diverse and inclusive workplace, encouraging applications from candidates of all backgrounds.

META

Company: Bamboohr

Title: Senior Manager / Associate Director, CMC Project Management

Listed

location: San Diego, California

Job type: Full-time

Apply URL: https://artivabio.bamboohr.com/careers/203

Tags: Director