Senior Consultant

Role Description

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.

Key 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.

Qualifications

• PhD in Chemistry, Analytical Chemistry, Biochemistry, or a related field preferred. Equivalent experience considered.
• 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:
  • The physical demands described here represent the requirements for successful performance of the essential functions. Reasonable accommodations may be made for individuals with disabilities.
  • While performing job duties, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen.
  • The role requires frequent walking and sitting, and occasional lifting of objects up to 25 pounds.
  • Vision requirements include close vision and the ability to adjust focus.
• Work Environment:
  • The work environment characteristics include a typical office environment with moderate noise levels, bright lighting, and an indoor temperate setting.

Benefits

• We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture.
• This includes a competitive base salary, annual incentive plan, comprehensive benefits, and ongoing recognition and career development opportunities.
• Employees benefit from flexible paid time off, company-paid holidays, flexible working hours, and remote work options for most roles.
• Office locations are available in Greater Boston; San Diego, CA; Boulder, CO; and India.