Head of CMC Development
Are you a dynamic leader with expertise in pharmaceutical development?
Do you excel at managing cross-functional teams in a fast-paced, multi-disciplinary environment?
Are you ready to lead the development and supply of innovative pharmaceuticals?
Fraser Dove International is partnering exclusively with a pioneering life sciences organisation. Operating globally from Philadelphia, they are committed to advancing life-changing pharmaceuticals for patients.
Our client is seeking an experienced leader to oversee global CMC & MSAT activities.
Discover more about our Head of CMC Development opportunity; its objectives, duties/responsibilities, and the skills, experience, and competencies needed to succeed.
Your objectives:
As the Head of CMC Development, you will be measured against the following objectives:
- Lead the development and manufacturing of novel pharmaceuticals for clinical trials.
- Ensure the seamless operation of contract manufacturing organisations (CMO) and supply chain activities.
- Oversee the implementation of CMC regulatory and compliance strategies in alignment with global standards.
What you will do:
As the Head of CMC Development, your duties and responsibilities will include:
- Lead cross-functional teams to develop, manufacture, and supply novel pharmaceuticals.
- Collaborate with CMC regulatory, manufacturing, and supply chain teams to execute CMC strategies.
- Oversee just-in-time manufacturing of pharmaceutical IMPs at global CMOs.
- Develop and execute supply chain strategies for manufacturing materials, precursors, and reference standards.
- Ensure compliance with global GMP and regulatory standards from FDA, EMA, and PMDA.
- Partner with global vendors to ensure timely and high-quality delivery of CMC activities.
- Drive continuous improvement in processes and cost efficiency.
- Manage CMC documentation lifecycle and ensure seamless transition of products to commercial operations.
- Stay updated on industry trends, regulatory changes, and technological advancements.
- Mentor and develop team members to enhance their contributions.
- Track project progress, budgets, and resources while reporting to senior management.
What you will bring:
These are the skills and experience you will need to succeed as the Head of CMC Development:
- Advanced degree in a scientific or engineering field.
- Experience in pharmaceutical development is required. Experience with radiopharmaceuticals highly advantageous.
- Strong leadership and management abilities with cross-functional teams.
- Expertise in cGMPs and CMC regulatory requirements.
- Exceptional organizational and problem-solving skills.
- Superior communication skills, both written and verbal.
- Ability to work in a fast-paced, evolving environment.
Got what it takes?
To apply for the Head of CMC Development, click the ‘Apply’ button below.
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 to perform any other job-related duties requested by any person authorised to give instructions or assignments.
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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.