Consultant II

Responsibilities

• Design and develop stable formulations for high concentration subcutaneous dosage forms
• Optimize lyophilization processes to ensure product stability and efficacy
• Manage formulation design transfer to CDMO partners and draft comparability protocols
• Ensure analytical activities comply with FDA, EMA, and ICH regulatory guidelines
• Prepare and review regulatory submissions including INDs and CTAs
• Collaborate with CMC teams, including analytical development, drug substance, QA, and regulatory affairs
• Communicate drug product gaps and development strategies to stakeholders
• Support all phases of clinical development through formulation design
• Manage multiple projects simultaneously to meet formulation and project timelines
• Mentor junior staff on formulation design and regulatory requirements

Requirements

• PhD in Chemistry, Analytical Chemistry, Biochemistry, or related field (or equivalent experience)
• Minimum 10 years of experience in formulation development
• Expertise in lyophilization drug products and high concentration subcutaneous dosage forms
• Strong understanding of regulatory guidance and submission preparation
• Proven ability to work cross-functionally within CMC environments
• Excellent interpersonal and communication skills
• Ability to work independently and manage time effectively
• Willingness to travel occasionally to client sites

About the Company

Syner-G is a strategic biopharma product development and delivery partner that accelerates breakthrough science and the delivery of life-enhancing therapies to patients. Recognized as one of BioSpace's "Best Places to Work," Syner-G supports organizations from drug discovery through commercialization.