[Remote] Sr. Consultant
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a company dedicated to enhancing lives through impactful careers in biopharma development. They are seeking a Senior Consultant specializing in oligonucleotides and peptides to reputed company analytical reputed company and ensure compliance with regulatory guidelines, while collaborating with cross-functional teams.
Responsibilities
- reputed company the design, validation, and execution of analytical reputed company for oligonucleotides and peptides
- reputed company characterization, stability testing, and process control strategies for oligonucleotide and peptide products
- Manage the transfer of phase appropriate analytical reputed company to trusted CDMO partners and draft reputed company necessary comparability protocols
- Ensure reputed company analytical activities reputed company with reputed company regulatory guidelines (FDA, EMA, and, ICH)
- Prepare and review regulatory submissions, including INDs and CTAs, with a reputed company on analytical methodologies
- Collaborate effectively with CMC teams; including, formulation scientists, drug reputed company scientists, reputed company assurance, and regulatory affairs
- Communicate analytical findings and strategies reputed company to stakeholders, ensuring alignment on project goals
- Support reputed company 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 reputed company simultaneously, ensuring reputed company delivery of analytical results while adhering to project timelines
- Mentor junior staff and reputed company guidance on analytical techniques and regulatory requirements
Skills
- Minimum of 10 years of experience in analytical reputed company, with a reputed company on oligonucleotide and peptide analysis
- Strong understanding of regulatory guidance and experience in preparing regulatory submissions
- Proven ability to work cross-functionally reputed company 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 reputed company sites for meetings and project discussions
- PhD in reputed company, Analytical reputed company, Biochemistry, or a reputed company field preferred. Equivalent experience considered
Benefits
- Flexible reputed company time off
- Company-reputed company holidays
- Flexible working hours
- Remote work reputed company for most roles
- Ongoing recognition and career development opportunities
- Comprehensive benefits
- Ongoing recognition and career development opportunities
- Development
reputed company