Senior Consultant

This is a fully remote position, open to applicants in United States.

📋 Description

• Supervise the design, validation, and implementation of analytical methods for oligonucleotides and peptides.

• Conduct characterization, stability assessments, and process control strategies for oligonucleotide and peptide products.

• Oversee the transfer of phase-appropriate analytical methods to reliable CDMO partners and prepare all required comparability protocols.

• Ensure that all analytical operations comply with current regulatory standards (FDA, EMA, and ICH).

• Prepare and review regulatory submissions, such as INDs and CTAs, with an emphasis on analytical methodologies.

• Collaborate effectively with CMC teams, including formulation scientists, drug substance scientists, quality assurance, and regulatory affairs.

• Clearly communicate analytical findings and strategies to stakeholders, ensuring alignment with project objectives.

• Support all phases of clinical development by providing analytical insights and data to guide decision-making.

• Participate in project meetings and assist in the development of clinical trial materials.

• Manage multiple projects concurrently, ensuring the timely delivery of analytical results while adhering to project schedules.

• Mentor junior staff and offer guidance on analytical techniques and regulatory standards.

⛳️ Requirements

• PhD in Chemistry, Analytical Chemistry, Biochemistry, or a related discipline is preferred.

• At least 10 years of experience in analytical chemistry, specializing in oligonucleotide and peptide analysis.

• Strong knowledge of regulatory guidelines and experience in preparing regulatory submissions.

• Demonstrated ability to work collaboratively across CMC teams.

• Excellent interpersonal and communication skills to foster collaboration across departments.

• Capability to work independently with minimal supervision and manage time efficiently.

• Willingness to travel occasionally to client locations for meetings and project discussions.

🏝️ Benefits

• Competitive base salary

• Annual incentive plan

• Comprehensive benefits

• Flexible paid time off

• Company-paid holidays

• Flexible working hours

• Remote work options