At a Glance
- Tasks: Lead and coordinate complex CMC programmes in a dynamic biotech environment.
- Company: Join an innovative late-stage biotechnology company making waves in drug development.
- Benefits: 12-month remote contract with competitive pay and growth opportunities.
- Other info: Collaborative culture with significant visibility across the organisation.
- Why this job: Be at the forefront of pharmaceutical innovation and regulatory readiness.
- Qualifications: Experience in CMC, project management, and small molecule development required.
The predicted salary is between 60000 - 80000 £ per year.
Allerton Bishop is delighted to be partnering with an innovative late-stage biotechnology company to appoint a Senior CMC Project Manager on a 12-month contract basis. This is an exciting opportunity to join a rapidly advancing development-stage organisation as it prepares a lead small molecule asset for late stage development, regulatory submission and future commercialisation.
Working closely with senior CMC, Technical Operations and Regulatory leaders, you will play a critical role in driving programme execution across Drug Substance, Drug Product, Supply Chain and external manufacturing activities. The successful candidate will operate at the centre of a highly collaborative cross-functional environment, ensuring critical development milestones, manufacturing activities and regulatory deliverables are achieved on time and to the highest quality standards.
The Opportunity
As Senior CMC Project Manager, you will be responsible for coordinating and driving complex CMC programmes across internal teams, CDMOs, analytical partners and external stakeholders. You will provide project leadership across pharmaceutical development, manufacturing, supply chain and regulatory activities whilst ensuring alignment with late stage readiness and future commercial objectives. This role offers significant visibility across the organisation and will suit an experienced CMC professional who combines strong technical understanding with excellent programme management capabilities.
Key Responsibilities
- CMC Programme Leadership
- Lead and coordinate cross-functional CMC activities supporting late stage development and commercial readiness.
- Develop and maintain integrated programme plans, critical paths, timelines and risk registers.
- Drive alignment between Technical Operations, Regulatory Affairs, Quality, Supply Chain and external manufacturing partners.
- Support governance activities and executive project reporting.
- Drug Substance & Drug Product Development
- Coordinate development and manufacturing activities across Drug Substance and Drug Product programmes.
- Support process development, technology transfer and manufacturing scale-up activities.
- Monitor critical deliverables to ensure programme milestones are achieved.
- CDMO & External Partner Management
- Manage relationships with CDMOs, analytical laboratories and external development partners.
- Coordinate project deliverables, timelines and issue resolution activities.
- Support technical transfer, vendor management and commercial readiness initiatives.
- Regulatory & Commercial Readiness Support
- Support CMC activities associated with global regulatory submissions and registration programmes.
- Coordinate documentation, technical reports and supporting information required for regulatory filings.
- Ensure development activities align with future NDA and MAA submission requirements.
- Supply Chain & Clinical Operations
- Support clinical supply planning and manufacturing scheduling activities.
- Coordinate logistics, inventory management and supply continuity programmes.
- Work closely with Clinical Operations and Supply Chain teams to ensure uninterrupted product availability.
Candidate Profile
Successful candidates are likely to come from biotechnology companies, pharmaceutical manufacturers, CDMOs or specialist development organisations. We are particularly interested in professionals who have supported late-stage development programmes and understand the challenges associated with late stage readiness, regulatory submissions and commercial launch preparation.
Essential Experience
- Significant experience within CMC, Technical Operations, Pharmaceutical Development or Project Management.
- Experience supporting small molecule Drug Substance and/or Drug Product development programmes.
- Strong background managing CDMOs and external manufacturing partners.
- Experience operating within GMP-regulated pharmaceutical environments.
- Excellent project management, stakeholder management and communication skills.
- Ability to coordinate multiple complex workstreams simultaneously.
Senior CMC Project Manager in Southampton employer: Allerton Bishop Search
Join a pioneering late-stage biotechnology company that values innovation and collaboration, offering a dynamic remote work environment across the UK and Europe. As a Senior CMC Project Manager, you will benefit from a culture that prioritises professional growth, with opportunities to lead critical projects in drug development while working alongside industry experts. This role not only provides significant visibility within the organisation but also allows you to contribute meaningfully to the future of pharmaceutical advancements.
StudySmarter Expert Advice🤫
We think this is how you could land Senior CMC Project Manager in Southampton
✨Tip Number 1
Network like a pro! Reach out to your connections in the biotech and pharmaceutical sectors. Attend industry events or webinars, and don’t be shy about asking for introductions. We all know that sometimes it’s not just what you know, but who you know!
✨Tip Number 2
Prepare for interviews by researching the company and its recent projects. Understand their late-stage development processes and be ready to discuss how your experience aligns with their needs. We want you to shine and show them you’re the perfect fit for their Senior CMC Project Manager role!
✨Tip Number 3
Practice your pitch! You should be able to clearly articulate your experience in managing CDMOs and leading complex CMC programmes. We recommend rehearsing with a friend or in front of a mirror to boost your confidence before those big interviews.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always on the lookout for talented individuals like you to join our network in the biotech and pharmaceutical fields.
We think you need these skills to ace Senior CMC Project Manager in Southampton
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Senior CMC Project Manager role. Highlight your experience in CMC, Technical Operations, and any relevant project management skills that align with the job description.
Craft a Compelling Cover Letter:Your cover letter should tell us why you're the perfect fit for this role. Share specific examples of your past experiences in drug substance and product development, and how they relate to the responsibilities outlined in the job description.
Showcase Your Collaborative Spirit:Since this role involves working closely with various teams, emphasise your ability to collaborate effectively. Mention any cross-functional projects you've led or been part of, and how you navigated challenges with stakeholders.
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. This way, we can easily track your application and ensure it gets the attention it deserves!
How to prepare for a job interview at Allerton Bishop Search
✨Know Your CMC Inside Out
Make sure you brush up on your knowledge of CMC processes, especially around Drug Substance and Drug Product development. Be ready to discuss specific examples from your past experiences that demonstrate your understanding of late-stage readiness and regulatory submissions.
✨Showcase Your Project Management Skills
Prepare to highlight your project management capabilities by discussing how you've successfully coordinated complex programmes in the past. Use the STAR method (Situation, Task, Action, Result) to structure your answers and illustrate your ability to manage multiple workstreams effectively.
✨Engage with Stakeholders
Since this role involves a lot of cross-functional collaboration, be prepared to talk about how you've managed relationships with CDMOs and external partners. Share specific instances where your communication skills helped resolve issues or align teams towards common goals.
✨Align with Company Goals
Research the company’s current projects and future objectives. During the interview, express how your experience aligns with their goals, particularly in terms of NDA and MAA readiness. This shows that you're not just interested in the role, but also in contributing to their success.
