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Syner-G BioPharma Group

Senior Consultant

Syner-G BioPharma Group

Sr. Consultant at Syner-G specializing in oligonucleotides and peptides.

Posted 6/11/2026full-timeRemote • 🇺🇸 United StatesSeniorWebsite

About the role

Key responsibilities & impact
  • 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.

Requirements

What you’ll need
  • PhD in Chemistry, Analytical Chemistry, Biochemistry, or a related field preferred
  • 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

Benefits

Comp & perks
  • Competitive base salary
  • Annual incentive plan
  • Comprehensive benefits
  • Flexible paid time off
  • Company-paid holidays
  • Flexible working hours
  • Remote work options

ATS Keywords

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Hard Skills & Tools
analytical methodscharacterizationstability testingprocess control strategiesregulatory submissionsINDsCTAsanalytical techniquesoligonucleotide analysispeptide analysis
Soft Skills
interpersonal skillscommunication skillscollaborationtime managementmentoringindependenceproject management
Certifications
PhD in ChemistryPhD in Analytical ChemistryPhD in Biochemistry