Oversee the design, validation, and execution of analytical methods for oligonucleotides and peptides.
Perform characterization, stability testing, and process control strategies for oligonucleotide and peptide products.
Manage the transfer of phase appropriate analytical methods to trusted CDMO partners and draft all necessary comparability protocols.
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 analytical methodologies.
Collaborate effectively with CMC teams; including, formulation scientists, drug substance scientists, quality assurance, and regulatory affairs.
Communicate analytical findings and strategies clearly to stakeholders, ensuring alignment on project goals.
Support all phases of clinical development by providing analytical insights and data 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 analytical results while adhering to project timelines.
Mentor junior staff and provide guidance on analytical techniques and regulatory requirements.
QUALIFICATIONS AND REQUIREMENTS:
Education:
PhD in Chemistry, Analytical Chemistry, Biochemistry, or a related field preferred. Equivalent experience considered.
Requirements
Minimum of 10 years of experience in analytical chemistry, with a focus on oligonucleotide and peptide analysis.
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.
ESSENTIAL FUNCTIONS:
Physical Demands:
Work Environment:
The work environment characteristics include a typic
Benefits
Vision insurance
Additional Information
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 www.Synergbiopharma.com
POSITION OVERVIEW:
Syner-G is seeking a Sr, Consultant specializing in oligonucleotides and peptides with a minimum of ten years of experience. The ideal candidate will have a deep understanding of current regulatory guidance and a proven ability to work cross-functionally within a Chemistry, Manufacturing, and Controls (CMC) team. This role requires strong interpersonal skills, the ability to operate independently with minimal supervision, and experience across all phases of clinical development. A PhD in a relevant field is preferred.
Synerg · Worldwide