Senior Analytical Scientist — Method Development & Compliance

Socket.dev; Edinburgh (IN); On-site; USD 110,000 - 160,000; Full time

Job summary

Sentry BioPharma Services seeks an Analytical Development Scientist to advance our laboratory capabilities and product quality in a startup-like environment. You will lead method development for small molecules and biologics, ensuring compliance with ICH guidelines and regulatory standards.

The role requires hands-on experience with HPLC/UPLC, GC, LC-MS/MS, and dissolution testing, plus strong problem-solving and communication skills.

Qualifications

• Proven experience in analytical method development and validation for small molecules and biologics.
• Proficiency with HPLC/UPLC, GC, LC-MS/MS, and dissolution testing techniques.
• Strong understanding of ICH guidelines, regulatory requirements, and quality assurance processes.
• Excellent problem-solving skills, attention to detail, and ability to work independently and collaboratively.
• Effective communication skills for documenting and presenting technical data.
• Familiarity with ICH guidelines (Q2, Q3, Q6, etc.) and regulatory expectations.
• Experience with biologics, peptides, or advanced modalities.
• Knowledge of statistical tools and software (e.g. Chromeleon, LIMS or other similar tools).
• Experience working in regulated GMP environments.

Responsibilities

• Lead hands-on development, optimization, and validation of analytical methods.
• Design and execute analytical studies using HPLC/UPLC, GC, LC-MS/MS, dissolution testing, and spectroscopy.
• Collaborate with cross-functional teams to meet project requirements and regulatory standards.
• Maintain documentation of method development, validation, and study results.
• Support stability testing programs and analytical testing for products.
• Maintain laboratory equipment, calibration, qualification, and preventive maintenance.
• Stay current with industry trends, regulatory updates, and analytical chemistry advancements.
• Assist in audit readiness and speak to auditors as QC SME.

Skills

Analytical method development

HPLC/UPLC

GC

LC-MS/MS

Dissolution testing

ICH guidelines

Regulatory knowledge

Problem solving

Communication skills

Biologics experience

GMP experience

Statistical tools

Chromeleon

LIMS

Education

PhD in Chemistry

MS in Chemistry

BS in Chemistry

Tools

Chromeleon

LIMS

Job description

Sentry BioPharma Services seeks an Analytical Development Scientist to advance our laboratory capabilities and product quality in a startup-like environment. You will lead method development for small molecules and biologics, ensuring compliance with ICH guidelines and regulatory standards.

The role requires hands-on experience with HPLC/UPLC, GC, LC-MS/MS, and dissolution testing, plus strong problem-solving and communication skills.