Drug Substance Tech Transfer Lead

Job summary

The role involves leading the technology transfer of new products into large-scale manufacturing operations, ensuring successful and compliant introductions of clinical, PPQ, and commercial processes.

Qualifications

• Master’s degree in Biochemical/Chemical Engineering or a relevant scientific field.
• Minimum 8 years of experience in the pharmaceutical or biotech industry in CMC process development and/or GMP manufacturing.
• Prior experience as a Tech Transfer Lead or CMC Project Manager.
• Strong understanding of biopharmaceutical manufacturing and GMP principles; experience in cell culture and/or protein purification is advantageous.

Responsibilities

• Serve as the primary technical point of contact for internal teams and customers during technology transfer.
• Develop and manage integrated project plans aligned with program scope and priorities.
• Facilitate cross-functional communication and coordinate regular tech transfer meetings.
• Identify, escalate, and mitigate risks while tracking milestones and deliverables.
• Support CMC activities and ensure alignment with regulatory filings and GMP requirements.
• Guide technical investigations and develop tailored PPQ strategies in collaboration with stakeholders.
• Champion best practices for tech transfer and PPQ globally.

Skills

• Strategic and detail-oriented with a focus on quality and compliance.
• Strong communication and facilitation skills with a collaborative mindset.
• Proficient in risk management, problem-solving, and decision-making in a customer-facing environment.
• Ability to thrive in a dynamic, fast-paced setting with multiple priorities.

Education

• Master’s degree in a relevant scientific field.

Tools

• Familiarity with project management tools and methodologies relevant to CMC and GMP processes.