Consultant II

Job not on LinkedIn

🕒 June 10

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

💼 Consultant

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Syner-G BioPharma Group

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Syner-G BioPharma Group is the world's leading provider of chemistry, manufacturing and controls (CMC), regulatory affairs, and medical writing solutions for the biopharma sector. They offer comprehensive services that navigate clients through the complexities of pharmaceutical development, regulatory submissions, and quality compliance, ensuring high-quality outcomes. With a multidisciplinary team, Syner-G integrates science, engineering, and regulatory expertise to support drug development from pre-IND to post-approval phases, enabling timely submissions and patient safety adherence.

📋 Description

• 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.

🎯 Requirements

• PhD in Chemistry, Analytical Chemistry, Biochemistry, or a related field preferred. Equivalent experience considered. • Minimum of 10 years of experience in formulation development, with a focus on lyophilization drug products and high concentration dosage forms for sub cutaneous 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.

🏖️ Benefits

• Flexible paid time off • Company-paid holidays • Flexible working hours • Remote work options for most roles • Office locations available in Greater Boston; San Diego, CA; Boulder, CO; and India.