Remote Lead, Biologic Drug Product Development

Syncromune®; Fort Lauderdale (FL); On-site; USD 165,000 - 205,000; Full time

Benefits offered by this job

Incentive compensation

Employee benefits

Equity incentive

Job summary

Syncromune is seeking an Associate Director of Drug Product Development to lead formulation and process development for biologics from clinical to commercial stages. The role oversees CDMOs, ensures regulatory readiness, and drives QbD/DoE strategies across GMP manufacturing and tech transfer.

You will collaborate with Drug Substance, Analytical Development, QA, Regulatory Affairs, and Manufacturing to deliver robust, scalable drug product processes with lifecycle management and strong quality

Qualifications

• Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Biochemistry, Bioengineering, or related field.
• Experience in biologic drug product development, formulation, and GMP manufacturing.
• Strong knowledge of QbD, DoE, and regulatory expectations for biologics.

Responsibilities

• Lead formulation development for multi-component biologic products from clinical to commercial stages.
• Oversee CDMO activities for formulation development and technology transfer.
• Collaborate with Drug Substance Development, Analytical Development, Quality Assurance, Regulatory Affairs, and Manufacturing.

Skills

Biologic formulation

Process development

GMP manufacturing

Quality by Design

DoE

CMC knowledge

Regulatory submissions

External partnerships

Education

Ph.D. in Pharmaceutical Sciences

M.S. in related field

Job description

Syncromune is seeking an Associate Director of Drug Product Development to lead formulation and process development for biologics from clinical to commercial stages. The role oversees CDMOs, ensures regulatory readiness, and drives QbD/DoE strategies across GMP manufacturing and tech transfer.

You will collaborate with Drug Substance, Analytical Development, QA, Regulatory Affairs, and Manufacturing to deliver robust, scalable drug product processes with lifecycle management and strong quality