Senior Principal, Pharma CMC & Tech Transfer

vardaspace; El Segundo (CA); On-site; USD 190,000 - 280,000; Full time

Job summary

Varda in El Segundo, CA seeks a Principal Engineer, Pharma CMC Manufacturing & Tech Transfer to lead process transfer, CDMO qualification, and GMP manufacturing oversight for the crystallization and drug product pipeline. Reporting to the VP, CMC, this role builds the network to transfer lab processes into validated manufacturing packages with external partners.

You will select and qualify CDMO partners, execute tech transfer, run pilot scale batches, and help shape Varda's strategic

Qualifications

• 10+ years of CMC manufacturing and/or technology transfer leadership experience advancing drug product development programs to successful clinical trials.
• B.S. or M.S. in life sciences, chemical engineering, or related field
• Firm understanding of cGMP and FDA regulatory guidelines as they pertain to CMC manufacturing and tech transfer
• Demonstrated experience managing external CDMO/CMO relationships, including technical oversight and contract negotiation

Responsibilities

• Own technology transfer execution: translate R&D developed processes into robust, CDMO-ready transfer packages
• Lead pilot plant production of material to support nonclinical development
• Lead selection, qualification, and ongoing management of CDMO partners across the manufacturing network (Crystallization, Fill-Finish, and DS Partner)
• Lead tech transfer of drug product fill-finish processes for the crystalline suspension, partnering with R&D on process- and product-specific technology transfer coordination
• Negotiate and manage Manufacturing Services Agreements with CDMO partners, defining scope, key terms, and deliverables, in partnership with Legal and Quality
• Establish the CDMO oversight model, including defined chain of custody across CDMO handoffs
• Lead engineering run execution and acceptance at CDMO sites, including comparability protocols confirming CDMO-produced material matches Varda-characterized material
• As volumes increase, build and lead an internal Manufacturing Sciences & Technology (MS&T) function to support process transfer, engineering runs, and GMP manufacturing oversight
• Oversee GMP manufacturing campaigns through batch release, partnering with Quality on batch record review, change control, deviation management, and release testing coordination
• Manage CDMO manufacturing timelines and budget; report progress regularly to the VP, CMC and executive team
• Partner with Quality & Regulatory on control strategy, release specifications, and CMC sections of regulatory filings related to manufacturing and tech transfer

Skills

CMC leadership

Tech transfer

CDMO management

GMP compliance

Education

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

Job description

Varda in El Segundo, CA seeks a Principal Engineer, Pharma CMC Manufacturing & Tech Transfer to lead process transfer, CDMO qualification, and GMP manufacturing oversight for the crystallization and drug product pipeline. Reporting to the VP, CMC, this role builds the network to transfer lab processes into validated manufacturing packages with external partners.

You will select and qualify CDMO partners, execute tech transfer, run pilot scale batches, and help shape Varda's strategic