Senior Analytical Scientist — Drug Development Leader

Altasciences; Harleysville (PA); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Health/Dental/Vision Insurance Plans

401(k)/RRSP with Employer Match

Paid Vacation and Holidays

Paid Sick and Bereavement Leave

Employee Assistance & Telehealth

Telework when applicable

Job summary

Altasciences is seeking a Senior Analytical Scientist to lead analytical method development and validation for drug discovery and development. The role emphasizes cross-functional collaboration, regulatory alignment, and data integrity in a GLP/GMP environment.

You will mentor junior scientists, develop high-throughput analytical workflows, and contribute to regulatory submissions while ensuring robust, reproducible data generation and interpretation.

Qualifications

• Bachelor’s degree in Engineering, Chemistry, Pharmaceutical Sciences or related field; Master’s or PhD preferred.
• 8+ years of industry experience in analytical method development and qualification.
• Experience in dissolution method development and IVIVC.
• Experience with ICH/USP/BP/EP/JP guidance for regulatory submissions.

Responsibilities

• Design and manage analytical approaches to support early drug development projects (R&D, Preclinical and Phase I).
• Oversee and review planning, development, and interpretation of analytical studies.
• Lead development, qualification, validation, and transfer of analytical methods.
• Collaborate cross-functionally to apply analytical techniques and data visualization tools.
• Ensure methods follow ICH Q2/Q14 principles.
• Lead method studies with high-quality, reproducible data.
• Contribute to regulatory submissions by authoring quality modules.
• Work with Formulation Development, manufacturing and QA teams.
• Lead end-to-end analytical method development projects and mentor junior scientists.
• Develop and implement new analytical technologies and high-throughput workflows.

Skills

Analytical method development

Method qualification

Regulatory submissions

GLP/GMP experience

Mentoring

Cross-functional collaboration

ICH guidelines

Education

Bachelor’s in Engineering or Chemistry

Master’s or PhD preferred

Tools

HPLC/UPLC

Analytical instrumentation

Data visualization

Office software (Word, Excel)

Job description

Altasciences is seeking a Senior Analytical Scientist to lead analytical method development and validation for drug discovery and development. The role emphasizes cross-functional collaboration, regulatory alignment, and data integrity in a GLP/GMP environment.

You will mentor junior scientists, develop high-throughput analytical workflows, and contribute to regulatory submissions while ensuring robust, reproducible data generation and interpretation.