Sr. Consultant

Company Description

Syner-G enables its people to build careers that impact positively on their quality of life. We accelerate breakthrough science and delivery of life-enhancing therapies to more patients through our expertise, insight, consulting, and management skills. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization.

About the role

At Syner-G, you play an instrumental role in maintaining our reputation as a strategic biopharma product development and delivery partner. We are committed to fostering a positive and engaging work environment, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership, and innovation.

Position Overview

Syner-G is seeking a Senior Consultant specializing in oligonucleotides and peptides with a minimum of ten years of experience.

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 Contract Development and Manufacturing Organizations (CDMOs) 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 Investigational New Drug (IND) applications and Clinical Trial Applications (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

• 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.

Total Rewards Program

• A competitive base salary.
• An annual incentive plan.
• A comprehensive benefits package.
• Ongoing recognition and career development opportunities.
• Flexible paid time off.
• Company-paid holidays.
• Flexible working hours.
• Remote work options for most roles.

Work Environment

The work environment is a typical office setting with moderate noise levels, bright lighting, and an indoor temperate setting.

Legal Statement

Syner-G is an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate on the basis of 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.