Sr. Director - CMC Development
Are you an experienced leader in pharmaceutical manufacturing?
Do you have a passion for driving the development of radiopharmaceutical products?
Are you ready to lead cross-functional teams in a fast-paced environment?
Fraser Dove International is partnering exclusively with a leading healthcare organisation. Operating globally, they are committed to making life better for people around the world through the discovery and development of life-changing medicines.
Our client is seeking an innovative leader to oversee CMC Development and lead the manufacturing operations of radiopharmaceutical products.
Discover more about our Sr. Director - CMC Development opportunity; its objectives, duties/responsibilities, and the skills, experience, and competencies needed to succeed.
Your objectives:
As the Sr. Director - CMC Development, you will be measured against the following objectives:
- 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.
What you will do:
As the Sr. Director - CMC Development, your duties and responsibilities will include:
· Lead multidisciplinary 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.
What you will bring:
These are the skills and experience you will need to succeed as the Sr. Director - CMC Development:
· 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 organizational skills and adaptability in a fast-paced environment.
Got what it takes?
To apply for the Sr. Director - CMC Development, click the ‘Apply’ button below or contact the Executive Search Consultant – [INSERT CONSULTANT NAME] – on +44 (0)203 355 7050.
Please Note:
· This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and perform any other job-related duties requested by any person authorized to give instructions or assignments.
· If you have not heard from an Executive Search Consultant within ten working days from the date of your application, please consider yourself unsuccessful on this occasion.
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Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture, and distribute life-changing drugs, treatments, and devices which transform and save patient lives.
