Associate Director/Director Of Process Development - 233195

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Job Summary: Responsibilities include CDMO selection, CDMO Management, and CMC managementDevelop 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.


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