Job Description

Syqe Medical is an innovative startup developing breakthrough technologies for the precise delivery of therapeutic molecules via inhalation. Our mission is to enhance patients’ quality of life by making advanced treatments accessible, effective, and fast-acting.

We are seeking a highly motivated and experienced Scientist to lead aerosol performance and particle size characterization activities within our CMC laboratory. This role will lead the transfer and implementation of APSD and Laser Diffraction methods, including in-depth data analysis and definition of suitable analytical specifications to support IND submissions and Phase 3 development.

You will work closely with multidisciplinary teams — including QA/QC, Regulatory Affairs, and Clinical — to provide scientific and analytical expertise supporting the development, characterization, and control of inhalation drug-device combination products.

Responsibilities

• Lead development, optimization, and validation of Aerodynamic Particle Size Distribution (APSD) methods using NGI/ACI systems.
• Develop and validate Laser Diffraction (LD) methods for particle size analysis.
• Establish aerosol performance testing capabilities within the CMC laboratory.
• Write and execute method development, qualification, and validation protocols in accordance with ICH Q2 and regulatory expectations.
• Perform and oversee batch characterization.
• Investigate OOS/OOT results and conduct scientific root cause analyses.
• Contribute to the preparation of regulatory documentation for drug development submissions.
• Collaborate effectively with cross-functional teams to advance project goals.
• Support additional analytical chemistry activities within the CMC lab as needed.

Requirements

• M.Sc. or Ph.D. in Biotechnology, Chemistry, Chemical Engineering, Materials Engineering, or related field.
• Minimum 3 years of experience in analytical development within a pharmaceutical or regulated environment.
• Proven experience in analytical method development and validation (ICH Q2) – mandatory.
• Experience with inhalation products – mandatory.
• Strong understanding of particle size analysis and physical characterization techniques.
• Experience with APSD testing (NGI, ACI) – strong advantage.
• Experience with Laser Diffraction systems (e.g., Spraytec) – advantage.
• Experience supporting regulatory submissions (IND/CTA/Module 3) – advantage.
• Strong problem-solving skills and ability to work independently in a fast-paced startup environment.
• Ability to work effectively in a multidisciplinary team environment.
• Self-motivated, curious, and detail-oriented.