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- Tasks: Lead CMC activities for drug development and manage supply chain operations.
- Company: Join Ellipses Pharma, a pioneering global drug development company focused on cancer treatments.
- Benefits: Enjoy a dynamic work environment with opportunities for professional growth and collaboration.
- Why this job: Make a real impact in cancer treatment while working with top oncologists and innovative projects.
- Qualifications: Life science degree with 5+ years of CMC experience, preferably in oncology.
- Other info: Opportunity to work internationally and engage with leading experts in the field.
The predicted salary is between 72000 - 108000 £ per year.
Ellipses Pharma is a global drug development company headquartered in London, focused on accelerating the development of cancer treatments through an innovative drug development model that combines unbiased vetting to de-risk initial asset selection, the expertise of a Scientific Affairs Group, which comprises more than 300 leading oncologists and an uninterrupted funding flow to minimise the time it takes to advance lead products through clinical trials and reach patients.
Reporting to the Head of CMC, the CMC Director will have responsibility for all CMC-related activities across the Ellipses portfolio of assigned pre-clinical and clinical assets. The role will work closely with the Clinical Operations team, Head of Translational Medicine, and Asset Leader along with wider internal and external key collaborators and stakeholders.
Key Responsibilities:- Develop and lead CMC-related activities for drug substance and drug product development, manufacture, and supply, from in-license through to clinical development and registration / out-license for assigned assets.
- Responsible for establishing and managing development, manufacturing, and supply chain activities across the portfolio including CDMO selection, qualification, and management, with support from external SMEs as needed.
- Direct and manage CMC operational activities at third party suppliers.
- Working with the Asset Leader, support the Clinical Trial Managers with the coordination and use of specific external CMC consultancies as appropriate to ensure timely delivery of all CMC activity in support of project delivery.
- Act as CMC technical author and lead for CMC sections of Regulatory submissions, briefing documents, and interactions with appropriate authorities.
- Responsible for the review of cGMP manufacturing batch records, CMC regulatory and quality documents. Prepare technical reports, publications and oral presentations.
- Work with the QP for batch release/ declaration and certification.
- Responsible for CMC project management and integration of the CMC plans into the Asset strategy including risk analysis and mitigation.
- Contribute to the preparation of the annual budgets for CMC activity and track spend to ensure all activity is in line with the financial plans.
- Work with the business development team at Ellipses to provide expert CMC input into the review of potential new assets on which the company is conducting due diligence and may in-license.
- Life science degree or related discipline with a minimum of 5 years broad CMC sponsor side experience.
- Experience in the oncology therapy area would be desirable and of expedited development pathways (e.g. Breakthrough Therapy / Fast Track etc).
- Significant experience within a biotech environment within a clinical trial sponsor organisation.
- A drug product or drug substance specialist but with a sound understanding across the CMC lifecycle.
- Confident acting as internal CMC expert across all asset types (preferably biologics) and able to utilise external expertise to support specific CMC requirements.
- Experience across pre-clinical, Phase 1 and Phase 2 trials.
- Experience in authoring CMC sections for regulatory filings and an ability to deal with complex CMC regulatory issues and requirements and proficient in interpreting international regulations.
- Demonstrate strong project management skills including planning, prioritisation, adherence to strict deadlines and managing multiple projects simultaneously with multiple external parties.
- Experience of working internationally with partners and providers.
CMC Associate Director/Director (London) employer: Placed
Contact Detail:
Placed Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land CMC Associate Director/Director (London)
✨Tip Number 1
Network with professionals in the oncology and CMC fields. Attend industry conferences, webinars, or local meetups to connect with people who work at Ellipses Pharma or similar companies. Building relationships can often lead to insider information about job openings and company culture.
✨Tip Number 2
Familiarise yourself with the latest trends and developments in CMC processes, especially in oncology. Being well-versed in expedited development pathways like Breakthrough Therapy or Fast Track can set you apart during discussions with potential employers.
✨Tip Number 3
Prepare to discuss your project management experience in detail. Be ready to share specific examples of how you've successfully managed multiple projects simultaneously, particularly in a biotech environment, as this is crucial for the role.
✨Tip Number 4
Research Ellipses Pharma's portfolio and recent projects. Understanding their current assets and challenges will allow you to tailor your conversations and demonstrate your genuine interest in contributing to their mission.
We think you need these skills to ace CMC Associate Director/Director (London)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in CMC activities, particularly in drug substance and drug product development. Emphasise any experience you have in oncology and clinical trials, as well as your project management skills.
Craft a Compelling Cover Letter: Write a cover letter that specifically addresses the key responsibilities outlined in the job description. Mention your experience with regulatory submissions and your ability to manage CMC operational activities, showcasing how you can contribute to Ellipses Pharma's goals.
Highlight Relevant Skills: In your application, clearly outline your skills related to CMC lifecycle management, including your understanding of cGMP manufacturing and your experience with external CMC consultancies. This will demonstrate your capability to handle the responsibilities of the role.
Showcase Your Achievements: Include specific examples of past achievements in your application, such as successful project completions or improvements in CMC processes. Quantifying your successes can make your application stand out and show your impact in previous roles.
How to prepare for a job interview at Placed
✨Know Your CMC Inside Out
Make sure you have a solid understanding of the CMC lifecycle, especially in relation to drug substance and drug product development. Be prepared to discuss your experience with CDMO selection and management, as well as any specific challenges you've faced in previous roles.
✨Showcase Your Oncology Knowledge
Since the role is focused on cancer treatments, brush up on the latest developments in oncology therapies. Be ready to discuss expedited development pathways like Breakthrough Therapy or Fast Track designations, and how your experience aligns with these processes.
✨Demonstrate Project Management Skills
Highlight your project management experience, particularly in managing multiple projects simultaneously. Prepare examples that showcase your ability to plan, prioritise, and adhere to strict deadlines while collaborating with various stakeholders.
✨Prepare for Regulatory Discussions
As the role involves authoring CMC sections for regulatory submissions, be ready to discuss your experience with complex CMC regulatory issues. Familiarise yourself with international regulations and be prepared to explain how you've navigated these in past projects.
