At a Glance
- Tasks: Lead analytical activities for innovative biologics and ADC programs, ensuring quality and compliance.
- Company: Join Engitix, a pioneering biotech transforming drug discovery in London.
- Benefits: Enjoy competitive pay, private medical insurance, pension, bonuses, 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 science and 8+ years in analytical development required.
The predicted salary is between 70000 - 90000 £ per year.
We are seeking an experienced Analytical CMC Lead 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.
Your profile
- 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.
Why us?
- 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 employer: Engitix Therapeutics
Engitix is an exceptional employer located in the vibrant White City Place, West London, offering a dynamic and collaborative work environment that fosters innovation in drug discovery. Employees benefit from a competitive package that includes private medical insurance, pension, and bonuses, alongside ample opportunities for professional growth and development in the cutting-edge field of biotechnology. Join us to be part of a pioneering team dedicated to transforming therapies for advanced fibrosis and solid tumours, making a meaningful impact on patients' lives.
StudySmarter Expert Advice🤫
We think this is how you could land CMC Analytical Lead
✨Tip Number 1
Network like a pro! Reach out to professionals in the biotech field, especially those who work with CMC activities. Attend industry events or webinars to make connections and learn about potential job openings.
✨Tip Number 2
Prepare for interviews by brushing up on your technical knowledge. Be ready to discuss your experience with analytical method development and QC activities. We want you to showcase your expertise in biologics and ADCs!
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, send a thank-you email to express your appreciation and reiterate your interest in the role. It shows professionalism and keeps you on their radar.
✨Tip Number 4
Apply directly through our website! It’s the best way to ensure your application gets seen. Plus, it shows your enthusiasm for joining Engitix and being part of our mission to transform drug discovery.
We think you need these skills to ace CMC Analytical Lead
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that match the CMC Analytical Lead role. Highlight your expertise in analytical development, especially with biologics and ADCs, to catch our eye!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about the role and how your background aligns with our mission at Engitix. Be genuine and let your personality come through.
Showcase Relevant Experience:When detailing your experience, focus on specific projects or roles where you led analytical activities or managed CDMO interactions. We want to see how you've tackled challenges and contributed to successful outcomes.
Apply Through Our Website:We encourage you to apply directly through our website for the best chance of being noticed. It’s the easiest way for us to keep track of your application and get back to you quickly!
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
As a CMC Analytical Lead, you'll need to demonstrate your ability to lead teams and manage projects. Prepare examples of how you've successfully overseen analytical development and QC activities, particularly in cross-functional settings. Highlight your experience with CDMOs and how you've navigated those relationships.
✨Prepare for Technical Questions
Expect in-depth technical questions about analytical methods, stability testing, and regulatory submissions. Review key concepts and be ready to explain your thought process behind developing analytical control strategies and how you've handled challenges in past projects.
✨Cultural Fit Matters
Engitix values collaboration and innovation, so be prepared to discuss how you work within a team and contribute to a fast-paced environment. Share examples of how you've adapted to change and driven results in previous roles, showing that you're not just a fit for the role, but for the company culture too.
