Vice President, Td and Cmc Strategy Lead
3 weeks ago
**The Role**:
This pivotal role is divided into two primary functions within the organization:
**Technical Development Initiatives Leader**: Directs the governance of Technical Development (TD) initiatives, focusing on strategy development and coordination across project teams. This role ensures that each initiative aligns with the department’s priorities and delivers a clear value proposition, overseeing the lifecycle of initiatives from inception and sponsorship to potential adjustments and completion.
**Strategic CMC Implementation Leader**: Manages the strategic incorporation of new platform technologies into the Chemistry, Manufacturing, and Control (CMC) organization. This role involves broad operational and portfolio-level coordination, facilitating the integration of these technologies across multiple products or clinical programs.
**Here’s What You’ll Do**:Strategic Leadership and Initiative Governance**:
Develop and refine strategies for TD initiatives, ensuring alignment with broader departmental objectives and demonstrating a clear value proposition.
Lead the governance process, maintaining oversight over the lifecycle of initiatives, including their formation, strategic adjustments based on ongoing insights, and decisions on their continuation or completion.
**Project Leadership**:
Serve as the primary liaison between TD project teams, CMC business units, and Moderna Portfolio Program Teams, ensuring effective communication and collaboration.
Manage resources and timelines across projects, aiming for efficiency and adherence to deadlines.
Provide matrix leadership of project teams to enable the effective implementation of new platform technologies.
**CMC Implementation Oversight**:
Oversee the strategic integration of new platform technologies within the CMC framework, addressing both operational and product-level challenges.
Ensure that all CMC projects comply with established best practices and meet regulatory, quality, and business requirements.
**Cross-Functional Collaboration**:
Work closely with teams across regulatory affairs, quality assurance, manufacturing, and research and development to support project success.
Provide strategic insights and expert advice to facilitate decision-making at the executive level.
**Continuous Improvement**:
Lead initiatives to identify and implement improvements in project management and technology integration.
Stay informed about industry trends and advancements to ensure the department remains competitive in biotechnology innovation.
**Here’s What You’ll Bring to the Table**:Industry Experience**:
At least 10-15 years of progressive experience in the biotechnology or pharmaceutical industry, with significant exposure to process development, technology transfer, and manufacturing science.
**CMC Project Leadership**:
Proven track record in leading CMC integration projects, including regulatory submissions or operational implementation of novel technology into a cGMP environment, demonstrating a strong grasp of regulatory and operational complexities.
**Technical Expertise and Agility**:
**Strategic Planning and Execution**:
Demonstrated capability in strategic planning and project management, with a proven record of delivering projects on time and within budget.
**Curiosity and Continuous Learning**:
A strong innate curiosity and a proven track record of continuous learning and development, with a commitment to staying at the forefront of industry advancements.
**Leadership and Communication**:
Proven leadership skills with the ability to inspire and engage teams, fostering a culture of innovation and excellence.
**Adaptability and Innovation**:
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 fitness equipment
Adoption and family-planning benefits
Dedicated care coordination support for our LGBTQ+ community
**Generous paid time off, including**:
- Vacation, sick time and holidays
- Volunteer time to participate within your community
- D iscretionary year-end shutdown
- Paid sabbatical after 5 years; every 3 years thereafter
Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
401k match and Financial Planning tools
Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
Complimentary concierge service including home services research, travel booking, and entertainment requests
Free parking or subsidized commuter passes
Location-specific perks
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