Biologics & Gene Therapy Manufacturing Leader

Scorpion Therapeutics; Somerville (MA); Hybrid; USD 180,000 - 280,000; Full time

Job summary

Ultragenyx is seeking a technical leader to oversee external manufacturing for our biologics and gene therapy portfolio, guiding development through commercialization.

The role covers plasmid DNA, biologics, and oligonucleotide production, with oversight of CMOs, cGMP compliance, and global CMC filings. You’ll drive process optimization, tech transfer, and risk management across global teams.

Qualifications

• BS in Pharmaceutical, Biological, Bioengineering, or related field.
• 10+ years in biotech/pharma manufacturing, process development, or MSAT, with experience in biologics, gene therapies, or aseptic drug production.
• proven CMO/CDMO management.
• proficiency in cGMPs.
• financial acumen.
• strong collaboration and communication skills.
• ability to support global teams and schedules.

Responsibilities

• overseeing manufacturing of plasmid DNA, biologics, and oligonucleotides.
• managing CMO relationships.
• ensuring compliance with cGMP.
• authoring global CMC filings.
• leading process optimization and tech transfer.
• managing manufacturing risks, quality deviations, and process changes.

Skills

CMO/CDMO management

cGMP proficiency

Cross-functional collaboration

Communication

Education

BS in Pharmaceutical, Biological, Bioengineering, or related field

Job description

Ultragenyx is seeking a technical leader to oversee external manufacturing for our biologics and gene therapy portfolio, guiding development through commercialization.

The role covers plasmid DNA, biologics, and oligonucleotide production, with oversight of CMOs, cGMP compliance, and global CMC filings. You’ll drive process optimization, tech transfer, and risk management across global teams.