Syner-G
Consultant II
RemoteUnited States only
- Experience
- Lead
Salary not disclosed
Check eligibility
Open to US only. Set where you work from to check your eligibility.
No BS summary
Consultant II with 10+ years in formulation development, focusing on lyophilization and high concentration subcutaneous dosage forms. Must understand regulatory guidance (FDA, EMA, ICH) and collaborate within CMC teams across all clinical development phases. PhD preferred.
Core skills
lyophilizationhigh concentration dosage formssubcutaneous delivery
Required skills
formulation developmentdrug productINDsCTAs
What you'll do
- 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.
What they require
- 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
- 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
Syner-G is a strategic biopharma product development and delivery partner supporting clients from drug discovery and approval through commercialization.
Biopharma
Details
Visa sponsorshipNo
Salary not disclosed