Senior Specialist, CMC Drug Product (Biotechnology, Remote)

Job summary

The role involves contributing to late-stage development activities and preparing CMC documentation for regulatory submissions within a dynamic biotechnology environment. The position focuses on drug product activities and lifecycle management, requiring collaboration across various project teams.

Qualifications

• Master's degree in science, pharmacy, or a related technical field.
• Over 7 years of experience in CMC or related areas within the pharmaceutical, biotechnology, or medical device industries, particularly in lifecycle management and commercial manufacturing.
• Proven experience with late-stage development and commercialization of biologic drug products.

Responsibilities

• Manage drug product activities at partnered CMOs, including troubleshooting and process performance qualification.
• Review protocols and batch records to support the release of clinical and commercial batches.
• Author and review CMC regulatory submission documents.
• Collaborate with SMEs and project managers on late-stage drug product development and lifecycle management activities.

Skills

• Strong understanding of aseptic drug product processes and late-stage validation activities.
• Excellent communication skills in English, both written and oral.
• Ability to work effectively in multicultural teams and under tight deadlines.

Education

• Master's degree in a relevant field.

Tools

• Familiarity with regulatory documentation and Good Manufacturing Practice (GMP) standards. Travel may be required.