Manager, Drug Substance

Key Responsibilities

• Define and execute phase-appropriate Drug Substance CMC strategies from early development through Phase II/III.

• Provide technical oversight of process development, scale-up, and GMP manufacture.

• Ensure Drug Substance activities align with overall clinical and regulatory timelines.

• Act as the primary CMC point of contact for external CDMOs.

• Lead and support tech transfer activities, including process validation readiness.

• Review and approve development reports, batch records, and manufacturing documentation.

• Manage timelines, budgets, and technical risk across external partners.

• Contribute to CMC sections of regulatory submissions (IND/CTA/IMPD, amendments, and responses).

• Support preparation of Module 3 (Drug Substance) content.

• Participate in interactions with regulatory authorities and support agency questions.

• Ensure Drug Substance activities are conducted in compliance with GMP, ICH, and regulatory requirements.

• Support deviation investigations, change control, and continuous improvement initiatives.

• Collaborate closely with QA/QC and Supply Chain teams.

• Work closely with Drug Product, Analytical Development, Regulatory Affairs, Quality, and Clinical teams.

• Provide technical input to programme teams and CMC governance forums.

• Identify and mitigate technical and supply risks.

Qualifications & Experience

• MSc or PhD in Chemistry, Chemical Engineering, Biochemistry, Biotechnology, or related discipline.

• 5–8+ years of experience in Drug Substance CMC within biotech, pharma, or CDMO environments.

• Hands-on experience with process development, scale-up, and GMP manufacturing.

• Proven experience managing external CDMOs and tech transfers.

• Strong understanding of regulatory CMC requirements for clinical development.

• Excellent communication and stakeholder management skills.