Senior CMC Specialist (On-site)

Job summary

The role involves joining a Process Development team focused on late-stage development activities for antibody-drug conjugates (ADCs) within a growing organization. The Senior CMC Specialist will leverage expertise in organic chemistry and synthetic API manufacturing to contribute to drug linker development and regulatory filings.

Qualifications

• Degree in Chemistry, Organic Chemistry, Pharmaceutical Sciences, Chemical Engineering, Biochemistry, or a related field.
• Minimum of 6 years of professional experience in synthetic API manufacturing, process chemistry, or drug linker development.

Responsibilities

• Develop and implement strategies for chemical intermediates, payload linkers, and drug linkers.
• Collaborate with CMOs and partners to define the scope of late-stage drug linker development activities.
• Oversee development and manufacturing activities at partnered CMOs, including troubleshooting and process validation.
• Prepare and review technical documentation and CMC regulatory submission documents.
• Support continuous improvement of internal processes related to drug linker activities.

Skills

• Strong experience in synthetic organic chemistry and synthetic API manufacturing.
• Familiarity with drug linker and ADC-related development.
• Understanding of bioconjugation techniques and late-stage CMC development activities.

Education

• Relevant degree in a scientific field.

Tools

• Experience with technical documentation and regulatory submissions.