Sonia Appel

Founder and Principal Consultant

Background

• Master of Science degree in Chemistry/Biotechnology

• 7 years in molecular biology academic research, uncovering mechanisms of transmission and virulence of infectious diseases

• 20+ years in biotech industry, leading technical operations in commercial molecular diagnostics and pharmaceutical CMC

• Project Management Professional - PMP Certification

• Scientific work included in six publications in peer reviewed journals

MS, PMP

Connect on LinkedIn:

Contact via e-mail:

Work Style

• A natural inclination for pragmatism and organization - thriving in the creation of frameworks and prioritizations for highly complex or ambiguous situations

• Recognized for "getting things done" - delivering high quality results in record time

• Passionate for conceiving strategies, bringing ideas to fruition, and developing top technical talent, redefining organizational boundaries and achievements

• Highly collaborative strategist, achieving stakeholder and management alignment, and independently driving execution

Key Accomplishments

• Enabled successful IND module-3 submissions receiving safe-to-proceed letters in less than 30-days

• Managed CMC early drug development and off-site manufacturing from pre-clinical to phase 1/2, including small molecule and ADCs

• Led clinical supply chain operations supporting global clinical trials

• Developed and led teams of up to 15 scientists and managers supporting novel product launches and operational improvements in molecular diagnostics / medical devices

• Enabled production growth from 1 to over 25 lines of real-time PCR integrated kits, pushing operational boundaries and meeting the organization's profitability goals

• Managed the integration of cross-functional systems, including automation, software, chemistry, biology, liquid-fill, lyophilization, aseptic and nuclease-free techniques, achieving operational excellence and meeting quality and regulatory requirements

Bringing science and industry leadership to biotech project management