Senior Consultant

Syner-G BioPharma Group

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

Posted 6/10/2026full-timeRemote • 🇺🇸 United StatesSeniorWebsite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

analytical methodscharacterizationstability testingprocess control strategiesregulatory submissionsINDsCTAsanalytical techniquesoligonucleotide analysispeptide analysis

Soft Skills

interpersonal skillscommunication skillscollaborationtime managementmentoringindependenceproject management

Certifications & Qualifications

PhD in ChemistryPhD in Analytical ChemistryPhD in Biochemistry

Industry Keywords

FDAEMAICHCMCclinical developmentregulatory guidancecomparability protocolsclinical trial materials

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