Associate Director/Director of Process Development - 233195

Job Summary:

• Responsibilities include CDMO selection, CDMO Management, and CMC management
• Develop selection criteria and statements of work (SOW) for CDMO partners and vendors.
• Lead partner assessments, RFP process, CMO qualification, tech transfers, and cGMP manufacturing campaigns.
• Oversee CDMO onboarding, governance, risk management, and seamless project transfer.
• Manage deliverables related to cost, quality, and timing, while ensuring clear communication with all stakeholders.
• Review and audit cGMP batch records, SOPs, and regulatory filings (e.g., IND submissions to FDA).
• Provide technical expertise in process and product development, including upstream and downstream processing, formulation, and analytical development.
• Mentor junior team members and ensure proper documentation of lab work.

Qualifications

• PhD or Masters in Bioengineering, Biochemistry, or a related field with 5–10 years of industry experience.
• Expertise in upstream/downstream processing, purification, analytical techniques, and cGMP manufacturing.
• Strong communication, problem-solving skills, and ability to work in diverse teams.

We value diversity and are committed to providing equal opportunities for all employees.