Consultant II

Summary

Syner-G is a company focused on enhancing the quality of life through breakthrough science and life-enhancing therapies. They are seeking a highly skilled Consultant II with expertise in lyophilization and high concentration dosage forms for subcutaneous delivery, who will collaborate cross-functionally in a Chemistry, Manufacturing, and Controls (CMC) environment and assist clients in optimizing their processes.

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
• Participate in project meetings and contribute to the development of clinical trial materials
• Manage multiple projects simultaneously, ensuring timely delivery of formulation results while adhering to project timelines
• Mentor junior staff and provide guidance on formulation design and regulatory requirements

Skills

• Minimum of 10 years of experience in formulation development, with a focus on lyophilization drug products and high concentration dosage forms for subcutaneous delivery
• Strong understanding of regulatory guidance and experience in preparing regulatory submissions
• Proven ability to work cross-functionally within CMC teams
• Excellent interpersonal and communication skills to facilitate collaboration across departments
• Ability to work independently with minimal supervision and manage time effectively
• Willingness to travel occasionally to client sites for meetings and project discussions
• PhD in Chemistry, Analytical Chemistry, Biochemistry, or a related field preferred. Equivalent experience considered

Qualifications

Must Haves

• Minimum of 10 years of experience in formulation development, with a focus on lyophilization drug products and high concentration dosage forms for subcutaneous delivery
• Strong understanding of regulatory guidance and experience in preparing regulatory submissions
• Proven ability to work cross-functionally within CMC teams
• Excellent interpersonal and communication skills to facilitate collaboration across departments
• Ability to work independently with minimal supervision and manage time effectively
• Willingness to travel occasionally to client sites for meetings and project discussions

Nice to Haves

• PhD in Chemistry, Analytical Chemistry, Biochemistry, or a related field preferred. Equivalent experience considered

Benefits

• A competitive base salary
• Annual incentive plan
• Comprehensive benefits
• Ongoing recognition and career development opportunities
• Flexible paid time off
• Company-paid holidays
• Flexible working hours
• Remote work options for most roles