Syner-G · 1 week ago
Consultant II
United States
Full-time
Remote
Mid Level
10+ years expSyner-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.
HealthcareManufacturingPharmaceuticalHealth Care
No H1B
U.S. Citizen Only
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
Qualification
Required
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
Preferred
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
Company
Syner-G
Syner-G is a Strategic Development & Delivery Partner™ to biopharma innovators.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Ron Kraus
Chief Executive Officer
Prabu Nambiar
Founder, Board Member
Recent News
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