Pharma CMC Tech Transfer Lead - GMP & CDMO Oversight

Telemetry Today LLC; El Segundo (CA); On-site; USD 187,000 - 239,000; Full time

Benefits offered by this job

Stock options

Long-term cash awards

Job summary

Varda Space Industries in El Segundo, CA, seeks a Principal Engineer, Pharma CMC Manufacturing & Tech Transfer to drive process transfer, CDMO qualification, and GMP manufacturing oversight for crystallization and drug products.

Reporting to the VP, CMC, you will build a network of external partners, transfer lab processes to scalable manufacturing, and shape terrestrial and orbital manufacturing strategies across the company.

Qualifications

• 10+ years of CMC manufacturing and/or technology transfer leadership experience.
• B.S. or M.S. in life sciences, chemical engineering, or related field.
• Solid understanding of cGMP and FDA guidelines for CMC manufacturing.
• Experience managing external CDMO/CMO relationships and contracts.

Responsibilities

• Own technology transfer execution: translate R&D processes into CDMO-ready transfer packages.
• Lead pilot plant production for nonclinical development.
• Manage CDMO partners across the network with due diligence and capability assessments.
• Lead tech transfer of drug product fill-finish processes and coordination.
• Negotiate and manage Manufacturing Services Agreements with CDMOs.
• Establish a CDMO oversight model and chain of custody across handoffs.
• Oversee engineering runs and acceptance at CDMO sites with comparability protocols.
• Build and lead an internal MS&T function as volumes grow.
• Oversee GMP manufacturing campaigns with Quality for batch release and change control.
• Manage CDMO timelines and budget; report progress to VP, CMC and exec team.

Skills

CMC leadership

Life sciences degree

Regulatory expertise

CDMO partnerships

Education

B.S./M.S. in life sciences or chemical engineering

Job description

Varda Space Industries in El Segundo, CA, seeks a Principal Engineer, Pharma CMC Manufacturing & Tech Transfer to drive process transfer, CDMO qualification, and GMP manufacturing oversight for crystallization and drug products.

Reporting to the VP, CMC, you will build a network of external partners, transfer lab processes to scalable manufacturing, and shape terrestrial and orbital manufacturing strategies across the company.