Senior Consultant

Job not on LinkedIn

🔥 14 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

💼 Consultant

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Syner-G BioPharma Group

WebsiteLinkedInAll Job Openings

201 - 500 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syner-G BioPharma Group is the world's leading provider of chemistry, manufacturing and controls (CMC), regulatory affairs, and medical writing solutions for the biopharma sector. They offer comprehensive services that navigate clients through the complexities of pharmaceutical development, regulatory submissions, and quality compliance, ensuring high-quality outcomes. With a multidisciplinary team, Syner-G integrates science, engineering, and regulatory expertise to support drug development from pre-IND to post-approval phases, enabling timely submissions and patient safety adherence.

📋 Description

• 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.

🎯 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

🏖️ Benefits

• Competitive base salary • Annual incentive plan • Comprehensive benefits • Flexible paid time off • Company-paid holidays • Flexible working hours • Remote work options