CMC Program Lead — Biopharma Strategy & Compliance

Alentis Therapeutics; Allschwil; Hybrid; CHF 190,000 - 230,000; Full time

Job summary

Alentis Therapeutics in Allschwil, Switzerland, seeks a CMC Program Lead to drive the CMC strategy across product lifecycles, ensuring alignment with clinical demand and regulatory expectations.

You will oversee outsourced CMC activities, maintain inspection-ready records, and collaborate with Regulatory, QA and Clinical Supply to ensure timely material availability and compliant documentation in a fast-paced biotech setting.

Qualifications

• PhD in Biology, Biotechnology, Pharmacy, Pharmaceutical Sciences or related discipline.
• At least 7+ years in CMC development and management of biological products.
• Strong knowledge of GMP manufacturing and CMC regulatory requirements.
• Hands-on experience authoring or reviewing regulatory CMC documentation.
• Excellent planning and organizational skills with multi-priority management.
• Fluent in written and spoken English; other languages a plus.
• Proactive, collaborative in a fast-paced biotech environment.

Responsibilities

• Lead outsourced drug substance and drug product development in line with program objectives.
• Review and approve process, formulation and analytical development reports and records.
• Maintain manufacturing and supply plans; coordinate release documentation with Clinical Supply and QA.
• Track stability data and support shelf-life extensions with internal and external partners.
• Manage CMC project timelines, budgets and vendor contracts; update forecasts and invoices.
• Represent CMC in cross-functional teams and organize meetings with agendas and actions.
• Identify and mitigate quality, operational and organizational risks; escalate issues.
• Ensure GMP compliance and delivery of high-quality records for biopharmaceuticals.
• Prepare and review CMC sections of clinical trial applications and regulatory responses.

Skills

Project management

Regulatory documentation

GMP knowledge

Cross-functional communication

Attention to detail

English proficiency

Education

PhD in Biology or related field

Tools

Microsoft Office

Excel

Job description

Alentis Therapeutics in Allschwil, Switzerland, seeks a CMC Program Lead to drive the CMC strategy across product lifecycles, ensuring alignment with clinical demand and regulatory expectations.

You will oversee outsourced CMC activities, maintain inspection-ready records, and collaborate with Regulatory, QA and Clinical Supply to ensure timely material availability and compliant documentation in a fast-paced biotech setting.