Note: The job is a remote job and is open to candidates in USA. Syner-G is a company dedicated to enhancing lives through impactful careers in biopharma development. They are seeking a Senior Consultant specializing in oligonucleotides and peptides to oversee analytical methods and ensure compliance with regulatory guidelines, while collaborating with cross-functional teams.
Responsibilities
- 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
Skills
- 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
- PhD in Chemistry, Analytical Chemistry, Biochemistry, or a related field preferred. Equivalent experience considered
Benefits
- Flexible paid time off
- Company-paid holidays
- Flexible working hours
- Remote work options for most roles
- Ongoing recognition and career development opportunities
- Comprehensive benefits
- Ongoing recognition and career development opportunities
- Development
Company Overview