CMC Manager, Biologics & Global Manufacturing

SERB Pharmaceuticals; England; On-site; GBP 120,000 - 180,000; Full time

Job summary

SERB Pharmaceuticals in the United Kingdom seeks a senior professional to lead the management of CMC development and related commercial activities for biologics. The role covers technical CMC and process development studies across CDMOs and in-house sites.

You will provide manufacturing expertise, identify phase-appropriate studies, manage budgets, and work with global teams to support regulatory submissions and timely patient access. Strong leadership and CMC experience are essential.

Qualifications

• Bachelor's degree with a sound technical background.
• Excellent understanding and hands-on working knowledge of process development, manufacturing and CMC of biologics.
• Demonstrated ability to successfully manage outsourced manufacturing CDMO

Responsibilities

• Manage CMC studies in support of BLA/MAA preparation.
• Provide technical expertise to manufacturing activities for SERB products at CDMOs.
• Identify phase-appropriate studies and lead internal/outsourced activities to ensure studies are performed.
• Support setting CMC budgets and ensure adherence to this budget throughout the financial year.
• Provide due diligence support for in- and out-licensing products as required.
• Adhere to SERB’s polices on health, safety and workplace policies.
• Ensuring that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with SERB values.

Skills

Biologics manufacturing

CMO management

Negotiation

Leadership

Cross-functional communication

Data analysis

Strategic thinking

Education

Bachelor's degree with a sound technical background

Job description

SERB Pharmaceuticals in the United Kingdom seeks a senior professional to lead the management of CMC development and related commercial activities for biologics. The role covers technical CMC and process development studies across CDMOs and in-house sites.

You will provide manufacturing expertise, identify phase-appropriate studies, manage budgets, and work with global teams to support regulatory submissions and timely patient access. Strong leadership and CMC experience are essential.