Biologics CMC Manager (15-month FTC) – UK Field

BTG Pharmaceuticals (now SERB Pharmaceuticals); Pilton; Vor Ort; GBP 90.000 - 120.000; Vollzeit

Zusammenfassung

SERB Pharmaceuticals is seeking a CMC Manager (FTC 15 months) in the UK field to oversee CMC development and related activities for biologics across CDMOs and in-house sites. This role supports regulatory submissions and budget management with a strong emphasis on quality and collaboration.

The position requires a technical Bachelor's degree and hands-on experience in process development, biologics manufacturing, and managing outsourced CDMOs, with leadership and cross-functional collaboration

Qualifikationen

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

Aufgaben

• Manage CMC development and commercial activities for SERB products.
• Lead studies in support of regulatory submissions (BLA/MAA).
• Provide technical expertise to manufacturing activities for SERB products at CDMOs and in-house sites.
• Oversee setting and adherence to CMC budgets throughout the year.
• Ensure compliance with SERB policies and uphold high ethical standards.

Kenntnisse

Biologics manufacturing

CMC development

Regulatory submissions

CDMO management

Leadership

Cross-functional collaboration

Ausbildung

Bachelor's degree in a technical field

Jobbeschreibung

SERB Pharmaceuticals is seeking a CMC Manager (FTC 15 months) in the UK field to oversee CMC development and related activities for biologics across CDMOs and in-house sites. This role supports regulatory submissions and budget management with a strong emphasis on quality and collaboration.

The position requires a technical Bachelor's degree and hands-on experience in process development, biologics manufacturing, and managing outsourced CDMOs, with leadership and cross-functional collaboration