Senior Director, CMC Development Lead
2 months ago
Fraser Dove International is partnering with a leading healthcare organisation to find an innovative leader to oversee CMC Development and lead the manufacturing operations of radiopharmaceutical products.
Your Key Responsibilities:- Lead multidisciplinary teams to develop, manufacture, and supply novel PET radiopharmaceuticals.
- Ensure compliance with global GMP guidance and regulatory requirements.
- Drive continuous improvement initiatives to optimize processes and improve efficiency.
As the Sr. Director - CMC Development, your duties and responsibilities will include:
- Lead cross-functional teams to develop, manufacture, and supply novel PET radiopharmaceuticals.
- Collaborate with team leaders to ensure seamless execution of CMC strategies.
- Direct the operation of just-in-time manufacturing of PET radiopharmaceutical IMP at CMOs globally.
- Develop and execute supply chain strategies for materials needed in PET radiopharmaceutical manufacturing.
- Ensure compliance with global GMP guidance and regulatory requirements from agencies like FDA, EMA, and PMDA.
- Partner with global vendors to ensure timely and quality delivery of CMC activities.
- Drive continuous improvement initiatives to optimize processes, reduce costs, and enhance efficiency.
- Manage CMC documentation lifecycle and transition late-phase products to commercial operations.
- Mentor and develop team members to foster their professional growth.
- Monitor project progress, budget, and resource allocation.
- Advanced degree in a relevant scientific or engineering field.
- Experience with PET drug development.
- Proven leadership skills in managing multidisciplinary teams in drug development and supply.
- Advanced understanding of cGMPs and CMC regulatory requirements.
- Ability to manage people and drive engagement.
- Exceptional problem-solving and decision-making skills.
- Excellent written and verbal communication skills.
- Superior organisational skills and adaptability in a fast-paced environment.
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Senior Director, CMC Development Lead
2 months ago
Reston, Virginia, United States Fraser Dove International Full timeJob Summary:Fraser Dove International is seeking an experienced Senior Director, CMC Development Lead to oversee the development and manufacturing of radiopharmaceutical products. As a key member of our team, you will be responsible for leading cross-functional teams to drive the development of novel PET radiopharmaceuticals, ensuring compliance with global...
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Senior Director, Pharmaceutical Development
2 months ago
Reston, Virginia, United States Bayside Solutions Full timeJob Summary:We are seeking a highly experienced Senior Director to lead our drug product development activities, playing a critical role as the technical lead and CMC project lead. This position will be responsible for leading drug product development activities leading to NDA submission and commercialization, and developing and executing the CMC...
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Process Development Director
2 months ago
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Senior Director Product Quality Lead
3 weeks ago
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Senior Manager CMC Quality Control Writer
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3 weeks ago
Reston, Virginia, United States Volante Senior Living Full timeMarketing Leadership Opportunity at Volante Senior LivingWe are seeking a highly motivated and experienced marketing professional to join our team as a key leader in our marketing efforts. As a senior marketing director, you will be responsible for developing and executing marketing strategies to drive sales initiatives across our 20+ senior living...
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2 weeks ago
Reston, Virginia, United States Thor Companies Full timeThe Regulatory Affairs Director at Thor Companies will lead the development and implementation of regulatory strategies for Chemistry, Manufacturing, and Controls (CMC) components of Abbreviated New Drug Applications (ANDAs) and generic products. This role requires a deep understanding of regulatory requirements, strong project management skills, and the...
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2 weeks ago
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Senior Sales Director
3 weeks ago
Reston, Virginia, United States Pegasus Senior Living Full timeWe are seeking a highly motivated and experienced Sales Director to join our team at Pegasus Senior Living. As a Sales Director, you will be responsible for generating and closing qualified leads, managing and leading sales teams, and providing exceptional customer service.Key Responsibilities:Develop and implement sales strategies to drive business growth...
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4 weeks ago
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Senior Manager Regulatory Affairs III
4 weeks ago
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3 weeks ago
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Senior Land Development Director
2 weeks ago
Reston, Virginia, United States Metric Geo Full timeA reputable Home Builder, Metric Geo, is seeking a Senior Land Development Director to lead their growing team in Maryland. This position will oversee all Land Development operations and employees for the division. The company has an excellent reputation and builds communities throughout the country, providing equal employment opportunities to all employees...