Process Development Director

2 weeks ago


Rockville, Maryland, United States Medix™ Full time
Job Summary

Medix™ is seeking a highly skilled Process Development Director to lead our CDMO selection, management, and CMC management efforts. This is a critical role that requires expertise in upstream and downstream processing, formulation, and analytical development.

Key Responsibilities
  • Select and manage CDMOs, ensuring seamless project transfer and risk management.
  • Develop selection criteria and statements of work for CDMO partners and vendors.
  • Lead partner assessments, RFP processes, CMO qualification, tech transfers, and cGMP manufacturing campaigns.
  • Oversee CDMO onboarding, governance, and ensure clear communication with all stakeholders.
  • Manage deliverables related to cost, quality, and timing.
  • Review and audit cGMP batch records, SOPs, and regulatory filings.
  • Provide technical expertise in process and product development.
  • Mentor junior team members and ensure proper documentation of lab work.
Requirements
  • 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.
What We Offer

Medix™ values diversity and is committed to providing equal opportunities for all employees.



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