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 Therapeutics is an exceptional employer located in the vibrant Greater London area, offering a dynamic work culture that fosters innovation and collaboration. Employees benefit from competitive medical insurance and pension plans, alongside ample opportunities for professional growth in the cutting-edge field of macrophage biology. Join us to make a meaningful impact in fibrosis and oncology research while being part of a supportive and forward-thinking team.
StudySmarter Expert Advice🤫
We think this is how you could land CMC Analytical Lead in London
✨Get Involved in Local Research Communities
Tap into local biotechnology meetups and research forums. These are great places to mingle with industry professionals, share your passion, and even discover unadvertised job openings. It's all about getting your face known in the field!
✨Leverage University Alumni Networks
If you're a recent grad, don’t underestimate the power of your university’s alumni network! Reach out to alumni working in biotechnology to gather tips about job openings at companies like Engitix Therapeutics. You'd be surprised how willing people are to help out a fellow grad!
✨Show Off Your Projects
Curate a portfolio showcasing any research projects or internships you've completed in biotechnology. This tangible evidence of your skills can really impress employers when you chat with them at networking events or interviews. It's about making that killer first impression!
✨Stay Up-to-Date with Industry Trends
Biotech is a fast-paced field, so keeping yourself updated with the latest advancements is crucial. Attend industry conferences, webinars, or workshops to broaden your knowledge and meet potential employers. Plus, it’ll give you fantastic talking points for your interviews at places like Engitix Therapeutics!
We think you need these skills to ace CMC Analytical Lead in London
Some tips for your application 🫡
Show Off Your Lab Skills:In the biotechnology field, it's super important to highlight your lab experience in your CV. Be sure to mention specific techniques or instruments you've mastered (think PCR, gel electrophoresis, etc.) and any relevant projects you've worked on. This will show Engitix Therapeutics that you have the hands-on skills they need.
Tailor Your Technical Skills:Make sure to emphasise your technical skills, especially those relevant to the biotechnology sector. Include any software tools or programming languages you've used, like R or Python for data analysis, which could be key for this role at Engitix Therapeutics.
Craft a Compelling Cover Letter:Since this is a full-time role, your cover letter should reflect not only your passion for biotechnology but also your long-term career ambitions. Share why you're excited about the work that Engitix Therapeutics does and how you envision contributing to their goals. This shows that you’re not just looking for any job, but you're genuinely invested in this opportunity.
Include Your Papers and Projects:If you've published any papers or contributed to significant projects, mention them! These documents can boost your application and provide tangible evidence of your expertise in the biotechnology field. Don’t forget to link to any relevant publications or project summaries—this can set you apart from other candidates.
How to prepare for a job interview at Engitix Therapeutics
✨Brush Up on Lab Techniques
Since you're eyeing a full-time gig in biotechnology, make sure you're well-versed in the lab techniques relevant to the role. Be ready to talk about PCR, CRISPR, or any specific methods mentioned in the job description at Engitix Therapeutics. You might even be asked to demonstrate your understanding of these processes.
✨Know Your Bioinformatics Tools
Get comfortable with bioinformatics tools that are commonly used in the industry, like BLAST or Bioconductor. These are key in biotechnology, and having hands-on experience or at least familiarity can set you apart. Prepare to discuss any relevant projects you've worked on, especially if they involved data analysis or genomic research.
✨Show Your Teamwork Skills
Biotech often involves collaboration across multiple disciplines. Be ready to share stories that highlight your teamwork and communication skills, especially in research projects. Think about working with different teams at university or any internships – this is where you can show how well you fit into Engitix Therapeutics's culture.
✨Research Recent Biotech Innovations
Stay updated on the latest trends and breakthroughs in biotechnology. Knowing what's happening in the field can help you engage in more meaningful discussions during your interview. Bring up recent articles or advancements that excite you, especially those related to the work being done at Engitix Therapeutics. This shows your passion for the industry!
