Cmc analytical lead Work, Jobs in Westminster, Gtl (with Salaries)

CMC Analytical Lead
Engitix —London
- Doctoral degree
- Master's degree
- Project management
Quick apply
IT Support Specialist
Pharmaron —Hoddesdon
- Azure
- Computer Science
- Windows
Quick apply
Associate Director, Global Regulatory Science, CMC
Moderna, Inc. —London
- Full-time
- Engineering
- Master's degree
- Bachelor's degree
- Annual leave
1h
Compliance Advisory Officer
CMC Markets —London
- Full-time
- Analysis skills
- Communication skills
Senior Scientist (Laboratory Data Systems), Global Technical Development
Orchard Therapeutics —London
- Full-time
- Laboratory experience
- Java
- SQL
Quick apply
Regulatory Associate - UK Medicines
Reckitt —Slough
- Data analysis skills
- Communication skills
- Employee assistance programme
- Life insurance
9d
Associate Director, CMC Regulatory Affairs, International
Moderna, Inc. —London
- Full-time
- Engineering
- Master's degree
- Bachelor's degree
- Annual leave
Global Product Operations Leader – Therapeutic Dermatology
Galderma —London
- Full-time
- Engineering
- English
- Master's degree
Director, Analytical Chemistry
Pharmaron —Hoddesdon
- Doctoral degree
- Master's degree
- Bachelor's degree
Quick apply
Associate Director, CMC Regulatory Science, International
Moderna, Inc. —London
- Full-time
- Doctoral degree
- Master's degree
- Annual leave

Other jobs to consider

Find your next job by exploring related positions.

CMC Analytical Lead
Engitix —London
Oversee analytical method development, qualification, transfer, and lifecycle management for drug substance and drug product programs.
Quick apply
UKAS Laboratory Electrical Calibration Engineer (DC-RF) (Full Time)
DM Calibration Limited —Letchworth
Delivered through our mobile, on-site units or UKAS-approved laboratory, we keep our customers operating with minimal downtime, ensuring their equipment is…
£30,000 - £40,000 a year
Quick apply
9d

I want to receive the latest job alerts for cmc analytical lead in westminster, gtl

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

cmc analytical lead jobs near westminster, gtl

CMC Analytical Lead

Engitix
London

Quick apply

Job details

Benefits

Company pension
Private medical insurance

Qualifications

Doctoral degree
Master's degree
Project management
Leadership
Communication skills

Full job description

Your mission

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.

Quick apply

Refine Your Search

cmc analytical lead jobs in westminster, gtl

CMC Analytical Lead

IT Support Specialist

Associate Director, Global Regulatory Science, CMC

Compliance Advisory Officer

Senior Scientist (Laboratory Data Systems), Global Technical Development

Regulatory Associate - UK Medicines

Associate Director, CMC Regulatory Affairs, International

Global Product Operations Leader – Therapeutic Dermatology

Director, Analytical Chemistry

Associate Director, CMC Regulatory Science, International

Other jobs to consider

I want to receive the latest job alerts for cmc analytical lead in westminster, gtl

Explore jobs in more locations

Your mission

Your profile

Why us?

About us

Jobseeker tools

Employer Tools

Browse

Stay Connected