At a Glance
- Tasks: Lead CMC program execution and coordinate cross-functional projects in a dynamic biotech environment.
- Company: Join Apsida Life Science, a specialist recruitment firm in the thriving life sciences sector.
- Benefits: Gain valuable experience in a clinical-stage biotech company with a focus on innovation.
- Other info: Exciting opportunity for career growth in a supportive and collaborative setting.
- Why this job: Make a real impact in drug development while enhancing your project management skills.
- Qualifications: 5+ years in CMC or related fields; strong organisational and communication skills required.
The predicted salary is between 60000 - 80000 £ per year.
Apsida Life Science is currently partnering with a clinical-stage biotechnology company that is developing a potent, selective, and orally bioavailable small-molecule.
Responsibilities
- Support overall CMC program execution for Phase 3 readiness and commercial planning activities
- Develop and maintain integrated CMC timelines, project plans, risk registers, and action trackers
- Coordinate cross-functional meetings with internal stakeholders and external partners
- Track project deliverables and ensure alignment with regulatory and clinical milestones
- Prepare meeting agendas, minutes, and follow-up actions for governance and technical meetings
- Support inspection readiness and due diligence activities as needed
Budget & Financial Tracking
- Manage and track CMC-related budgets, purchase orders, invoices, and accruals
- Monitor spending against forecasts and support annual budgeting exercises
- Coordinate with Finance and external vendors to ensure timely processing of contracts and invoices
- Assist with vendor selection and management activities
Clinical Supply & Logistics
- Coordinate clinical supply manufacturing schedules, supply of raw materials and shipping logistics
- Manage shipment planning for drug substance, drug product, reference standards, and critical materials
- Work with Supply Chain and Clinical Operations to support global clinical trial requirements and commercial supply planning
- Ensure appropriate documentation for import/export, temperature monitoring, chain of custody, and GMP compliance
- Support inventory tracking and reconciliation activities
Qualifications
- Bachelor’s degree in chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or related discipline
- 5+ years of experience in CMC, Technical Operations, Manufacturing, Supply Chain, or Pharmaceutical Project Management
- Experience supporting clinical-stage small molecules
- Demonstrated experience managing external CDMOs and cross-functional projects
- Strong organisational and project management skills with the ability to manage multiple priorities simultaneously
- Familiarity with GMP regulations and pharmaceutical development processes
- Excellent communication and interpersonal skills
- Proficiency with Microsoft Office, project management tools, and budget tracking systems
If you are interested in learning more, please reach out to Sweetness Zono at Apsida Life Science: www.apsida.co.uk +44 (0) 744 134 2281
CMC Regulatory Manager in Plymouth employer: Apsida Life Science
Apsida Life Science is an exceptional employer, offering a dynamic work environment in the heart of the UK’s biotechnology sector. With a strong focus on employee growth and development, we provide opportunities for meaningful contributions to innovative projects while fostering a collaborative culture that values teamwork and open communication. Our commitment to supporting our staff through comprehensive training and a supportive network makes us an attractive choice for professionals seeking to advance their careers in life sciences.
StudySmarter Expert Advice🤫
We think this is how you could land CMC Regulatory Manager in Plymouth
✨Join Biotechnology Meetups
Get yourself into the loop by joining local biotech meetups or workshops. These events are perfect for making connections with professionals in the field and can often lead to temporary gigs through word-of-mouth. Plus, you'll get to hear about the latest trends and developments directly from the source.
✨Showcase Your Passion in Science
Consider starting a blog or social media channel to showcase your interest in biotechnology. Share the latest research, your insights, and even your projects. This will not only enhance your visibility in the community but also attract potential employers like Apsida Life Science who might be scrolling through for talent.
✨Tap into University Resources
If you’re still in school or recently graduated, don’t forget to use your university’s career services. They often have exclusive connections with companies looking for temporary staff. Reach out to them for internship listings and networking opportunities tailored to the biotech sector.
✨Apply Directly on Our Website
When you spot that perfect temporary role at Apsida Life Science, make sure to apply directly through our website. This way, you’ll be in the best position to get noticed quickly and can show your enthusiasm for the role while filling out the application.
We think you need these skills to ace CMC Regulatory Manager in Plymouth
Some tips for your application 🫡
Showcase Relevant Lab Skills:In the biotech world, your lab skills are paramount. Make sure your CV highlights specific techniques and equipment you’ve used, such as PCR, gel electrophoresis, or cell culture. This will give us a clear picture of what you can bring to Apsida Life Science as a temporary teammate.
Highlight Your Research Experience:If you’ve worked on any research projects — whether during your studies or in previous positions — make sure to detail these in your application. Include the objective, your role, and what you achieved. This will help us see your potential and fit for the temporary position at Apsida Life Science.
Keep It Concise and Relevant:Especially for a temporary role, we want to see a clear and focused application. Tailor your CV and cover letter to emphasise the qualifications and experiences that are most relevant to the biotech field and the specific role at Apsida Life Science. This shows us you’re genuinely interested and capable.
Be Clear About Your Availability:Since it’s a temporary role, let us know right away when you’re available to start and how long you can commit. Include this in your cover letter — this kind of transparency saves us all time and helps us find the right fit quickly at Apsida Life Science.
How to prepare for a job interview at Apsida Life Science
✨Brush Up on Your Biotech Basics
Understanding the fundamental concepts in biotechnology is crucial. Be ready to discuss core topics like genetics, molecular biology, or bioinformatics, especially if you're asked technical questions. We suggest revisiting your coursework or recent projects to refresh your memory.
✨Demonstrate Your Adaptability
Since this is a temporary role, they’re likely looking for someone who can jump in and get up to speed quickly. Share experiences where you’ve adapted to new environments, tools, or teams in a short space of time. It shows you're ready to tackle the challenge head-on!
✨Emphasise Your Lab Experience
If you’ve got hands-on experience in lab settings, now’s the time to showcase it. Talk about specific techniques you’ve mastered, like PCR or chromatography, and any relevant safety protocols you’ve followed. These details help paint you as an effective team member from day one.
✨Be Prepared to Explain Your Passion
Hiring managers want to see your motivation, especially for a temporary position in a fast-paced field like biotechnology. Be ready to discuss what excites you about the industry, your career goals, and how this role at Apsida Life Science aligns with them. It’s all about showing that you’re not just looking for a job, but a stepping stone in your biotech journey.
