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Senior Consultant
Syner-G BioPharma GroupSr. Consultant at Syner-G specializing in oligonucleotides and peptides.
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
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
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