At a Glance
- Tasks: Lead CMC strategy and oversee drug development in a dynamic biotech environment.
- Company: Join an innovative clinical-stage biotech focused on novel therapies.
- Benefits: Flexible remote work, competitive pay, and potential for contract extension.
- Other info: Work approximately 2-2.5 days per week with excellent career growth opportunities.
- Why this job: Make a real impact in biotech while working with cutting-edge drug development.
- Qualifications: Extensive CMC experience and strong leadership skills required.
The predicted salary is between 63000 - 77000 £ per year.
Location: Remote – UK or Europe
Employment Type: Contract / Part-Time
Contract Duration: Initial 12 Months (Potential Extension)
Commitment: Approximately 2–2.5 Days Per Week (Flexible)
Compensation: Competitive Hourly/Daily Rate – Open Depending on Experience
Start Date: ASAP
About the Opportunity
APX Life Sciences is partnering with an innovative, clinical-stage biotechnology company focused on developing novel therapies. We are seeking a highly experienced Senior CMC Consultant / Fractional Head of CMC to provide strategic leadership and technical oversight across the company's ongoing clinical development programmes. This is a senior-level consulting opportunity within a lean biotechnology environment, working closely with executive leadership to oversee CMC strategy, outsourced manufacturing, regulatory activities and future clinical development milestones. The successful candidate will take ownership of the CMC function, managing external manufacturing partners and technical consultants while ensuring the company's drug development activities remain aligned with regulatory requirements and clinical timelines.
Key Responsibilities
- Lead and oversee the overall Chemistry, Manufacturing and Controls (CMC) strategy across clinical development programmes.
- Manage relationships with external Contract Development and Manufacturing Organisations (CDMOs) across the US and Europe.
- Provide technical oversight of drug substance (API) and drug product development, manufacturing and clinical supply activities.
- Oversee small-molecule formulation development, including oral liquid and capsule dosage forms.
- Provide strategic guidance on manufacturing processes, analytical development, stability, comparability and technical challenges.
- Lead and review regulatory CMC documentation, supporting IND, IMPD and future FDA/EMA submissions.
- Oversee external/ internal CMC specialists and technical consultants, ensuring quality and timely delivery of key programme milestones.
- Support GMP compliance, quality oversight and regulatory readiness across outsourced manufacturing activities.
- Identify and mitigate CMC-related risks, providing technical and strategic recommendations to senior leadership.
- Support the progression of clinical programmes from early-phase development towards later-stage clinical trials.
Candidate Requirements
- Extensive experience within Chemistry, Manufacturing and Controls (CMC), ideally operating at Senior Director, VP, Head of CMC or equivalent consulting level.
- Strong background in small-molecule pharmaceutical development, including drug substance and drug product manufacturing.
- Proven experience working within small or emerging clinical-stage biotechnology companies.
- Demonstrated ability to independently lead CMC activities within lean, outsourced operating models.
- Significant experience managing external CDMOs, manufacturing vendors and technical consultants.
- Strong understanding of FDA and EMA regulatory requirements, including CMC documentation for clinical trial applications and regulatory submissions.
- Experience supporting early-phase clinical development (Phase I/II), ideally with exposure to Phase IIb/III development.
- Knowledge of formulation development, process development, analytical methods, stability programmes and GMP manufacturing.
- Ability to provide both strategic CMC leadership and hands-on technical oversight.
- Excellent stakeholder management, communication and problem-solving skills.
- Previous experience operating as an independent CMC Consultant, Interim Head of CMC or Fractional CMC Leader.
- Experience with oral small-molecule formulations, including liquid and capsule dosage forms.
- Experience supporting manufacturing process changes, comparability assessments and bridging strategies.
- Experience supporting both US and European clinical development programmes.
This is an initial 12-month consulting engagement, with the potential for extension depending on programme requirements. The anticipated commitment is approximately 2–2.5 days per week, although this may fluctuate depending on manufacturing activities, regulatory milestones and clinical development needs. The position is fully remote, in the UK or Europe. Hourly or daily rates are open and negotiable, depending on the successful candidate’s experience and expertise.
Head of CMC Consultant - Small Biotech employer: APX Life Sciences
APX Life Science is an exceptional employer, offering a dynamic and collaborative work culture that fosters innovation and growth in the biotechnology sector. With a focus on employee development and a hands-on approach to clinical research, team members are empowered to make impactful contributions while enjoying the flexibility of a hybrid work environment in London. This role not only provides significant exposure to senior leadership but also allows for meaningful engagement with key opinion leaders, making it a rewarding opportunity for those looking to advance their careers in clinical development.
StudySmarter Expert Advice🤫
We think this is how you could land Head of CMC Consultant - Small Biotech
✨Tap into Your Uni's Resources
Universities are often at the forefront of biotech research, so don’t forget to use your career services to find part-time opportunities. Many labs look for students to assist with research and that’s a great way to get your foot in the door!
✨Get Involved with Biotech Communities
Join local biotech meetups and online forums like Biotech Connection or the Biotech Hub. These communities can not only keep you updated on new opportunities but also help you make valuable connections in the industry.
✨Showcase Your Lab Skills
If you've worked on any relevant projects or research, create a simple portfolio that highlights your lab skills and findings. This is especially important for part-time roles in biotechnology, as employers want to see what you can bring to their team.
✨Apply Directly Through Company Websites
Many biotech firms, including places like APX Life Sciences, often list part-time positions directly on their websites. Don’t hesitate to check these sites regularly and apply early—opportunities can fill up quickly!
We think you need these skills to ace Head of CMC Consultant - Small Biotech
Some tips for your application 🫡
Show Off Your Lab Skills:In biotechnology, lab skills are crucial. Highlight any relevant coursework, laboratory experience, or techniques you’ve mastered in your CV. If you have specific certifications, make sure to include those too—they can really set you apart!
Tailor Your CV to Biotech Buzzwords:Use industry-specific terms and buzzwords that resonate with biotechnology. We want to see evidence of your familiarity with concepts like CRISPR, bioinformatics, or genetic engineering. Tailoring your CV this way can catch the eye of hiring managers at APX Life Sciences.
Express Your Passion in the Cover Letter:Since this is a part-time gig, inject enthusiasm into your cover letter! Talk about why you’re keen to work in biotechnology and what you hope to learn from your time at APX Life Sciences. This is your chance to show your motivation and eagerness to grow in the field!
Keep it Concise but Impactful:Part-time positions often attract many applicants, so make every word count! Keep your CV to a couple of pages max, focusing on key experiences and skills that align with the job. Remember, less is more—quality over quantity!
How to prepare for a job interview at APX Life Sciences
✨Understanding the Science
Make sure you’re up-to-speed with the latest trends in biotechnology. Brush up on the key concepts and jargon in the field, as you'll likely face questions that assess your understanding of processes like gene editing or CRISPR technology. Showing genuine interest and knowledge will make us stand out at the interview with APX Life Sciences.
✨Showcase Your Laboratory Skills
For a part-time role, it's crucial to highlight any hands-on experience you have in lab settings. Be prepared to discuss specific techniques or tools you’ve used, whether it's PCR, gel electrophoresis, or bioinformatics software. If you've got examples from internships or university projects, bring them to the table to demonstrate your practical abilities.
✨Flexibility and Commitment
In a part-time role, being adaptable is key. Employers want to see that you're not only available at specific times but also willing to take on diverse tasks. Be ready to discuss your availability and how you can contribute to various projects at APX Life Sciences without compromising your studies or other commitments.
✨Prepare for Technical Questions
Expect some technical questions that may involve problem-solving scenarios relevant to biotechnology. Practise articulating how you would approach challenges or interpret data related to biological experiments. We should also consider being proactive and thinking about the implications of biotechnological advancements, as these discussions can really impress the interviewers.
