At a Glance
- Tasks: Lead analytical CMC activities for innovative biologics and ADC programs.
- Company: Join Engitix, a pioneering biotech transforming drug discovery in West London.
- Benefits: Competitive salary, private medical insurance, pension, bonus, and employee perks.
- Other info: Collaborative, fast-paced environment with opportunities for career growth.
- Why this job: Shape the future of targeted therapeutics and make a real impact on patient health.
- Qualifications: Advanced degree in relevant scientific discipline and 8+ years in analytical development.
The predicted salary is between 70000 - 90000 £ per year.
Your mission is to provide technical leadership for analytical activities supporting Engitix’s early-stage development programs. This role will lead analytical CMC activities, with responsibility for method development and validation, clinical release and stability, control strategy, and IND-enabling activities.
Experience supporting biologics programs is required, and experience with Antibody-Drug Conjugates (ADCs) is highly desirable.
Key Responsibilities:- Lead analytical CMC activities for early-stage biologics and/or ADC programs, with oversight of analytical development and QC activities at CDMOs and external laboratories.
- Serve as the primary analytical lead for CDMO interactions, managing technical execution, timelines, deliverables, and cross-functional coordination across CMC, quality, regulatory, manufacturing, and clinical supply teams.
- Oversee analytical method development, qualification, transfer, and lifecycle management for drug substance and drug product programs.
- Provide analytical oversight of QC activities including release and stability testing, characterization, reference standards, investigations, deviations, and change controls.
- Develop phase-appropriate analytical control strategies, including specification setting and justification, to support clinical development and regulatory requirements.
- Lead stability strategy and data review to support shelf-life and retest period assignments.
- Review analytical data to support process development, comparability, process characterization, investigations, and regulatory submissions.
- Author and review analytical CMC sections for INDs and other regulatory submissions, including specifications, analytical methods, qualification/validation summaries, comparability, and stability documentation.
- Support regulatory interactions and ensure analytical activities comply with GMP, ICH, and global regulatory expectations.
- Identify analytical and operational risks related to external execution and implement mitigation strategies to support program timelines and milestones.
- Advanced degree (M.S., Ph.D.) in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific discipline preferred.
- 8+ years experience in analytical development within biologics, large molecule, or bioconjugate CMC environments, or equivalent.
- Strong expertise in analytical characterization techniques for proteins and biologics.
- Experience overseeing QC testing, analytical outsourcing, and CDMO management.
- Demonstrated experience with analytical method development, qualification, transfer, and troubleshooting.
- Experience supporting stability programs, specification setting, and control strategy development.
- Working knowledge of early-phase regulatory expectations and IND-enabling activities.
- Experience authoring and reviewing analytical sections of IND submissions.
- Experience with ADCs is a strong plus.
- Experience with small-molecule analytics, including linker-payload characterization, is a plus.
- Strong project management, communication, and cross-functional collaboration skills.
Be part of a pioneering biotech transforming drug discovery through ECM biology. Work in a collaborative, fast-paced environment with opportunities to shape the future of targeted therapeutics. We offer a competitive package including private medical insurance, pension, bonus, employee perks and more.
About us:Engitix is a growing biotech company based in White City Place, West London. We are dedicated to developing better therapies for advanced fibrosis and solid tumours by leveraging our pioneering extracellular matrix (ECM) platform. Our platform allows the synthesis of realistic in vitro 3D models that serve as tools to transform our ability to identify new targets and biomarkers, determine mechanisms of action and more accurately predict the efficacy of therapeutic candidates. Join us today in our mission to create a healthier future for patients with life-threatening diseases such as fibrosis and cancer.
CMC Analytical Lead in London employer: Engitix Therapeutics
Engitix is an exceptional employer, offering a dynamic and collaborative work environment in the heart of White City Place, West London. With a strong focus on employee growth and development, we provide competitive benefits including private medical insurance, pension plans, and performance bonuses, all while empowering our team to shape the future of targeted therapeutics in a pioneering biotech setting.
StudySmarter Expert Advice🤫
We think this is how you could land CMC Analytical Lead in London
✨Network Like a Pro
Get out there and connect with people in the industry! Attend conferences, webinars, or local meetups related to biotech and CMC activities. You never know who might have a lead on your dream job or can introduce you to someone at Engitix.
✨Show Off Your Skills
When you get the chance to chat with potential employers, make sure to highlight your experience with analytical method development and QC testing. Share specific examples of how you've led projects or overcome challenges in previous roles to demonstrate your expertise.
✨Tailor Your Approach
Before any interview, do your homework on Engitix and their ECM platform. Tailor your responses to show how your background in biologics and ADCs aligns with their mission. This will help you stand out as a candidate who truly understands their needs.
✨Apply Through Our Website
Don’t forget to apply directly through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows your enthusiasm for joining the Engitix team and being part of our exciting journey.
We think you need these skills to ace CMC Analytical Lead in London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to highlight your experience in analytical CMC activities, especially with biologics and ADCs. We want to see how your skills align with the key responsibilities outlined in the job description.
Craft a Compelling Cover Letter:Your cover letter should tell us why you're the perfect fit for the Analytical CMC Lead role. Share specific examples of your past experiences that relate to method development, QC activities, and regulatory submissions.
Showcase Your Technical Skills:Don’t forget to emphasise your technical expertise in analytical characterisation techniques and project management. We’re looking for someone who can lead and manage effectively, so make that clear!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity at Engitix!
How to prepare for a job interview at Engitix Therapeutics
✨Know Your Stuff
Make sure you brush up on your knowledge of analytical CMC activities, especially in relation to biologics and ADCs. Be ready to discuss specific methods you've developed or validated, and how they align with the responsibilities outlined in the job description.
✨Showcase Your Leadership Skills
Since this role involves leading analytical activities, prepare examples that demonstrate your leadership experience. Think about times when you managed cross-functional teams or coordinated with CDMOs, and be ready to share how you ensured successful outcomes.
✨Understand Regulatory Expectations
Familiarise yourself with GMP, ICH guidelines, and IND-enabling activities. Be prepared to discuss how you've navigated regulatory submissions in the past, particularly focusing on analytical sections. This will show that you’re not just technically skilled but also aware of compliance requirements.
✨Ask Insightful Questions
Prepare thoughtful questions about Engitix’s current projects and future goals. This shows your genuine interest in the company and helps you gauge if it’s the right fit for you. Consider asking about their approach to stability strategy or how they handle QC testing challenges.
