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 the Manufacturing Science & Technology (MSAT) team. The position focuses on drug product activities and lifecycle management in a collaborative environment.

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 in late-stage development and commercialization of biologic drug products.
• Strong understanding of aseptic drug product processes and late-stage validation activities.
• Familiarity with regulatory documentation and Good Manufacturing Practice (GMP) quality documentation.
• Proficient in writing and reviewing regulatory market authorization documents (e.g., BLA, MAA) and clinical trial applications.
• Excellent communication skills in English, both written and verbal.

Responsibilities

• Oversee drug product activities at partnered CMOs, including troubleshooting and process performance qualification.
• Support drug product batch manufacturing by reviewing protocols and batch records for clinical and commercial projects.
• Author and review CMC regulatory submission documents.
• Collaborate with project managers and other SMEs on late-stage drug product development and lifecycle management activities.
• Ensure compliance with regulatory guidelines and industry standards.

Skills

• Goal-oriented with a focus on achieving team outcomes.
• Proactive and able to take initiative in a fast-paced environment.
• Strong team player capable of collaborating with diverse stakeholders.

Education

• Master's degree in a relevant field.

Tools

• Experience with regulatory documentation and quality management systems.