Executive Director, Cmc Portfolio Operations and - Norwood, United States - Moderna

Moderna

Verified Company

Norwood, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

The Role:

The Executive Director of CMC Portfolio Operations and Commercialization is a senior leadership role responsible for overseeing all Chemistry, Manufacturing, and Controls (CMC) activities related to the portfolio management, late-stage development, and commercial readiness of pharmaceutical products.

This position plays a critical role in guiding the strategic direction and operational execution of CMC functions to ensure successful product launches and compliance with global regulatory standards.

As a key member of the Technical Development Leadership Team, the Executive Director collaborates closely with senior leadership to ensure that CMC strategies are aligned with corporate objectives and efficiently integrated across the product lifecycle.

Here's What You'll Do:

Strategic Leadership in CMC Portfolio Management: Lead the strategic planning and execution of CMC activities for products through commercialization, managing and reporting on the overall portfolio of all development programs in alignment with the Development Operating Model.

Collaboration with Value Chain Management:
Develop and maintain a strong collaborative relationship with the Value Chain Management team.

This includes initiating and facilitating strategic handshakes between the CMC teams and Value Chain Management, which are essential for ensuring effective lifecycle management of products.

Collaboration with CMC Development Teams:

Coordinate closely with the Senior Director of CMC Development to ensure seamless progression of projects from CMC development to late-stage development and commercial readiness.

This role will consolidate and report activities to ensure comprehensive oversight across all stages of CMC development.

Cross-functional Collaboration: Work with cross-functional leaders in Clinical Development, Regulatory Affairs, Quality Assurance, and Manufacturing to ensure a seamless transition from development to commercial manufacturing.

Comprehensive Risk Management:
Develop and implement comprehensive risk management strategies to address potential challenges in product development and commercialization timelines.

Leadership and Team Development:
Mentor and lead a team of CMC professionals, fostering a culture of innovation, operational excellence, and continuous improvement.

Financial and Resource Management:
Direct the financial management of the CMC Commercialization portfolio, including budgeting, resource allocation, and cost management.

Adaptation to Industry Changes:
Stay informed on the latest industry trends, technological advancements, and regulatory updates to effectively adapt CMC strategies.

Here's What You'll Bring to the Table:
Demonstrated leadership and strategic management capabilities with extensive experience in CMC operations within the biopharmaceutical industry.

A proven track record of effectively managing a CMC Portfolio, demonstrating strategic oversight and tactical execution in aligning complex project demands with overarching product and portfolio development goals.

Expertise in driving product advancement from development through commercialization within a regulated biopharmaceutical environment is essential.

Possess technical knowledge and experience of drug development processes to make informed decisions on critical technical strategies. Ensure accountability for these strategies' effectiveness to meet the CMC Portfolio deliverables.

Deep understanding of the global regulatory landscape and quality standards critical to pharmaceutical product development and commercial manufacturing.

Strong communication, negotiation, and interpersonal skills, capable of influencing and collaborating with stakeholders across all organizational levels.

Proven ability to make strategic decisions in complex and dynamic environments.

Excellent problem-solving skills and adaptability to meet changing project requirements and business needs

Experience:

Minimum of 15 years of experience in the biopharmaceutical industry, including 5 years in a leadership role managing CMC functions for late-stage or commercial products.

A track record of leading successful regulatory submissions and product launches.

Educational Requirements:

Required:
Advanced degree (PhD or Master's) in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or a related scientific/engineering discipline.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
Highly competitive and inclusive medical, dental and vision coverage options
Flexible Spending Accounts for medical expenses and dependent care expenses
Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
Family care benefits, including subsidized back-up care options and on-demand tutoring
Free premium access to fitness, nutrition, and mindfulness classes
Exclusive preferred pricing on Peloton fi