Syner-G BioPharma Group
Consultant II
About this role
COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here. Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit POSITION OVERVIEW: Syner-G 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.
- 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. QUALIFICATIONS AND REQUIREMENTS: Education:
- PhD in Chemistry, Analytical Chemistry, Biochemistry, or a related field preferred. Equivalent experience considered. Experience: