CMC Lead - Cell & Gene Therapies (Technical Operations)

TN United Kingdom; London; On-site; GBP 60,000 - 100,000; Full time

Job summary

A forward-thinking company is seeking a CMC Lead for Technical Operations in London. This pivotal role involves leading a cross-functional team to execute the technical operations strategy for a commercial Cell & Gene Therapy product. The successful candidate will collaborate with various stakeholders to ensure project milestones are met while managing compliance with regulatory requirements. This role offers the opportunity to make a significant impact in the biotech industry, driving innovation and excellence in product development and lifecycle management. If you are a strategic leader with a passion for advancing therapies, this is the role for you.

Qualifications

• Substantial experience in Biotech/Pharmaceutical industry leading multidisciplinary teams.
• Strong knowledge of Supply Chain Management and drug development lifecycle.

Responsibilities

• Lead technical operations strategy for commercial products throughout their lifecycle.
• Collaborate with cross-functional teams to ensure alignment with product strategy.

Skills

Leadership

Stakeholder Management

Supply Chain Management

Analytical Skills

Project Management

Education

MSc in Biotechnology

PhD in Biological Sciences

Job description

Below is a refined version of the job description, with improved formatting and focus:

CMC Lead - Cell & Gene Therapies (Technical Operations), London

Client: Orchard Therapeutics

Location: London, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Reference: d9c594cbaa27

Posted: 05.05.2025

Expiry Date: 19.06.2025

Job Description:

Location: London

Reporting to: Vice President Technical Development and CMC PM

Job Summary:

The CMC Lead within Technical Operations is a key leadership role responsible for developing and executing the post-approval strategy for a commercial Cell & Gene Therapy product. The role involves leading a cross-functional team, overseeing planning, coordination, and execution of CMC strategies, and representing Technical Operations in the Program Strategy Team to ensure effective communication and collaboration.

Key Responsibilities:

• Lead technical operations strategy throughout the product lifecycle.
• Align technical activities with product strategy and business goals.
• Represent Tech Ops in the Program Strategy Team and manage communication with the extended team.
• Coordinate resources and budgets to meet project milestones from launch through post-approval.
• Develop project timelines, risk management plans, and collaborate across functions including Research, Clinical, Regulatory, and Commercial.
• Support product launches, market access, and lifecycle management through collaboration with marketing and regulatory teams.
• Ensure supply chain robustness and regulatory compliance across regions.
• Manage regulatory submissions and maintain compliance post-launch.
• Drive process improvements and build a high-performing team aligned with Orchard’s values.

Requirements:

Experience & Knowledge:

• Extensive biotech/pharmaceutical industry experience, including leading multidisciplinary teams.
• Experience with CMC strategy and lifecycle management for commercial products.
• Knowledge of supply chain management.
• Experience with ATMPs, HSCs, and Cell & Gene Therapies is advantageous.

Skills & Abilities:

• Understanding of drug development and lifecycle management, especially for ATMPs.
• Strong leadership, stakeholder management, and communication skills.
• Regulatory experience, including document preparation for submissions.
• Knowledge of GMP and regulatory standards.
• Analytical, problem-solving, and project management skills.

Education:

• MSc or PhD in biotechnology, biological sciences, gene therapy, or related fields.