Job 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 AND REQUIREMENTS:

Education:

• PhD in Chemistry, Analytical Chemistry, Biochemistry, or a related field preferred. Equivalent experience considered.

Experience:

• 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.

TOTAL REWARDS PROGRAM:
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.

Syner-G is unable to sponsor or take over sponsorship of employment visas at this time.

LEGAL STATEMENT:

Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.