[Hiring] Associate Director, Drug Product Development @Syncromune

Role Description

The Associate Director of Drug Product Development supports the planning and execution of the overall drug product (DP) development strategy from clinical development through commercialization for multi-component biologic drug products, including monoclonal antibodies (mAbs) and synthetic oligonucleotides. This role provides technical expertise and operational oversight for:

• Formulation development
• Formulation and process robustness characterization
• GMP manufacturing
• Process and product characterization
• Process validation
• Commercial readiness

This position ensures high-quality execution, adherence to project timelines, and compliance with regulatory and quality requirements across various stages of drug product development.

Qualifications

• Ph.D. or M.S. degree in Pharmaceutical Sciences, Chemical Engineering, Biochemistry, Bioengineering, or a related scientific discipline.
• Ph.D. with a minimum of 5 years of relevant biopharmaceutical industry experience; or M.S. with a minimum of 10 years of relevant experience.
• Demonstrated experience in biologic drug product development, particularly with monoclonal antibodies and oligonucleotide therapeutics.
• Extensive knowledge of formulation development for liquid and lyophilized injectable products.
• Strong understanding of drug product process development and GMP manufacturing.
• Proven experience managing external development and manufacturing partners.
• Demonstrated technical expertise in applying Quality by Design (QbD) and Design of Experiments (DoE) principles.
• Experience in oncology, immuno-oncology, and/or combination drug-device products is preferred.
• Proficiency in both English and Mandarin is highly desirable.

Requirements

• Serve as the technical subject matter expert (SME) for formulation development.
• Support the planning and execution of the overall drug product development strategy.
• Supervise CDMO to execute formulation development activities.
• Develop formulation control strategies based on product knowledge and regulatory expectations.
• Execute process development, scale-up, technology transfer, and GMP manufacturing activities.
• Support technology transfer to manufacturing partners.
• Collaborate closely with cross-functional teams to ensure successful execution of drug product development.
• Support Regulatory Affairs by authoring and reviewing CMC documentation.

Benefits

• Expected US salary range for Associate Director and Director levels: $165-$205K.
• This position is eligible for cash incentive compensation, equity incentive compensation, and employee benefits under the Company’s benefit plans.

Company Description

Syncromune is an Equal Opportunity Employer.