Consultant II

Position Overview

SynerG is seeking a highly skilled Consultant II with extensive expertise in lyophilization and high concentration dosage forms for subcutaneous delivery. The ideal candidate will possess a strong understanding of current regulatory guidance and demonstrate the ability to work cross-functionally in a collaborative Chemistry, Manufacturing, and Controls (CMC) environment. Candidate should also have experience working across all phases of clinical development.

Key Responsibilities

• Design and develop stable formulations for high concentration subcutaneous dosage forms.
• Assist clients with the appropriate experiments to optimize lyophilization processes, ensuring product stability and efficacy.
• Manage the transfer of formulation design to trusted CDMO partners and draft all necessary comparability protocols to enable success.
• Ensure all analytical activities comply with current regulatory guidelines (FDA, EMA, and ICH).
• Prepare and review regulatory submissions, including INDs and CTAs, with a focus on Drug Product.
• Collaborate effectively with CMC teams; including, analytical development scientists, drug substance scientists, quality assurance, and regulatory affairs.
• Communicate drug product gaps and development strategies clearly to stakeholders, ensuring alignment on project goals.
• Support all phases of clinical development by providing formulation development and design to inform decision-making.