CMC DEVELOPMENT in England

Job description

Contract Length: 12 months

Workload: 20 hours/week

Location: UK-based role

Start Date: November

Engagement: B2B

Role Overview:

We are seeking an experienced CMC leader to drive Chemistry, Manufacturing & Controls (CMC) activities for the late-stage clinical development of a novel Fc-fusion protein targeting NT-3 for chronic pain and osteoarthritis. This role will focus on ensuring readiness for large, global Phase III studies while managing end-of-Phase II CMC deliverables and regulatory expectations.

Key Responsibilities:

• Lead CMC activities for late-stage clinical development of the asset.
• Drive IND preparation and deliver end-of-Phase II CMC packages to support asset readiness for pivotal trials across multiple regions.
• Oversee fit-for-purpose CMC transition from Phase II to pivotal trials, closing data gaps and remediating deficiencies in technical packages.
• Collaborate closely with internal stakeholders and external CDMOs on process technology transfer, scale-up, DS/DP manufacturing, and late-phase CMC strategy.
• Advise the executive team on CMC risks, mitigation strategies, and regulatory interactions in the context of strategic partnerships and fundraising discussions.

Required Experience:

• Significant experience with late-stage CMC for biological fusion proteins.
• Proven track record in managing CMC for late-phase clinical trials (Phase II to Phase III).
• Strong knowledge of process technology transfer, scale-up, and DS/DP manufacturing.
• Experience in regulatory interactions and preparing IND/CMC submissions.

Preferred Qualifications:

• Strong communication skills to advise executive leadership.
• Ability to manage external CDMOs and cross-functional teams effectively.
• Experience in strategic partnering/fundraising scenarios is advantageous.

Additional Details:

• Availability: November
• Capacity: Up to 20 hours/week

Extra information

Status

Open

Education Level

Secondary School

Location

England

Type of Contract

Part-time jobs

Published at

01-11-2025

Profession type

Retail

Full UK/EU driving license preferred

No

Car Preferred

No

Must be eligible to work in the EU

No

Cover Letter Required

No

Languages

English