Senior Analytical Scientist

About the role

A Senior Analytical Scientist in the Pharmaceutical and Analytical development function is a senior-level technical role focused on developing, validating, and applying analytical methods to support drug discovery, development, and quality assurance. The role blends deep technical expertise with leadership, regulatory compliance, and cross-functional collaboration.

Responsibilities

• Design and manage analytical approaches to support early drug development projects (R&D, Preclinical and Phase I Clinical) with a focus on chromatographic, dissolution, particle size distribution, and spectrophotometry-based methods.
• Oversee and review the planning, development, execution, and interpretation of analytical studies performed by other scientists in a collaborative work environment.
• Lead the development, qualification, validation, and transfer of robust analytical methods, ensuring high-quality data generation and reproducibility.
• Collaborate cross-functionally to identify and apply optimal analytical techniques, including computational modeling, predictive tools, and data visualization platforms.
• Ensure analytical methods follow ICH Q2/Q14 principles.
• Lead the planning, execution, and interpretation of analytical method studies, ensuring high-quality, reproducible data.
• Evaluate scientific data to draw clear conclusions, guide future work, and communicate findings through presentations, technical reports, and other media.
• Contribute to regulatory submissions by authoring relevant sections of the quality modules, ensuring alignment with global standards.
• Work with Formulation Development, manufacturing, and quality teams to select and apply optimal analytical techniques.
• Lead analytical method development projects end to end and mentor junior scientists.
• Develop and implement new analytical technologies and high-throughput workflows.

Requirements

• Bachelor’s in Engineering, Chemistry, Pharmaceutical Sciences or related field. Master’s or PhD preferred.
• 8+ years of current industry experience in analytical method development and qualification (8+ years with Bachelor’s, 5+ years with Master’s or 3+ years with PhD).
• Experience in modern dissolution method development and IVIVC.
• Have a demonstrated history of applying current ICH/USP/BP/EP/JP guidance towards regulatory submissions.
• Proficiency with computer office tools (Word, Excel, Outlook, and miscellaneous scientific software).
• Extensive hands-on experience with Quantitative tests such as Assay, Content Uniformity, Dissolution, Particle Size Distribution, Preservative Assay, Related Substances, Residual Solvents, Resuspend ability, Viscosity, and other techniques for testing Drug Product Oral Solid dosage forms and data review in a pharmaceutical development and quality control laboratory setting.
• Familiarity with a broad range of analytical techniques, including HPLC/UPLC, disintegrations, compendial testing generic testing (e.g., UV, KF, titrations).
• Proficiency in analytical instrumentation and troubleshooting.
• Experience in a regulated laboratory environment (GLP/GMP).
• Proven ability to mentor team members.
• Independent thinker, proactive mindset, solution oriented, can-do-attitude, and results oriented to achieve successes while ensuring people-based leadership behavior.
• Experience with multiple dosage forms (e.g., solid oral, peptides, sterile, biologics, or specialized manufacturing).
• Detail-oriented with a high level of diligence.
• Strong presentation and communication abilities.
• Demonstrated interpersonal and facilitation skills.
• Ability to thrive in a collaborative, team-based environment.
• Capable of managing multiple projects in a fast-paced setting.
• Strong knowledge of laboratory CGMP regulations (FDA/EMA), and pharmaceutical quality systems.
• Must be self-directed, motivated, and have a willingness to take the initiative to identify and anticipate client needs and make recommendations for implementation.

Qualifications

• Bachelor’s in Engineering, Chemistry, Pharmaceutical Sciences or related field.
• Master’s or PhD preferred.
• 8+ years of current industry experience in analytical method development and qualification (8+ years with Bachelor’s, 5+ years with Master’s or 3+ years with PhD).
• Experience in modern dissolution method development and IVIVC.
• Proficiency with computer office tools (Word, Excel, Outlook, and miscellaneous scientific software).
• Extensive hands-on experience with Quantitative tests such as Assay, Content Uniformity, Dissolution, Particle Size Distribution, Preservative Assay, Related Substances, Residual Solvents, Resuspend ability, Viscosity, and other techniques for testing Drug Product Oral Solid dosage forms and data review in a pharmaceutical development and quality control laboratory setting.
• Familiarity with a broad range of analytical techniques, including HPLC/UPLC, disintegrations, compendial testing generic testing (e.g., UV, KF, titrations).
• Proficiency in analytical instrumentation and troubleshooting.
• Experience in a regulated laboratory environment (GLP/GMP).
• Proven ability to mentor team members.
• Independent thinker, proactive mindset, solution oriented, can-do-attitude, and results oriented to achieve successes while ensuring people-based leadership behavior.
• Experience with multiple dosage forms (e.g., solid oral, peptides, sterile, biologics, or specialized manufacturing).
• Detail-oriented with a high level of diligence.
• Strong presentation and communication abilities.
• Demonstrated interpersonal and facilitation skills.
• Ability to thrive in a collaborative, team-based environment.
• Capable of managing multiple projects in a fast-paced setting.
• Strong knowledge of laboratory CGMP regulations (FDA/EMA), and pharmaceutical quality systems.
• Must be self-directed, motivated, and have a willingness to take the initiative to identify and anticipate client needs and make recommendations for implementation.

Skills

• Strong understanding of analytical chemistry and its applications in pharmaceutical development.
• Experience with regulatory guidelines and submission processes.
• Excellent problem-solving and critical thinking skills.
• Strong organizational and project management skills.
• Effective communication and collaboration skills.
• Ability to work independently and as part of a team.
• Knowledge of laboratory safety protocols and practices.

Benefits

• Health/Dental/Vision Insurance Plans
• 401(k)/RRSP with Employer Match
• Paid Vacation and Holidays
• Paid Sick and Bereavement Leave
• Employee Assistance & Telehealth Programs
• Telework when applicable
• Incentive Programs Including Training & Development Programs and Employee Referral Bonus Program

Pay

Competitive salary based on experience and qualifications.

Schedule

Full-time position with flexible working hours to accommodate the needs of the role and the employee.

Company Culture

At Altasciences, we believe in moving in unison to deliver a big impact with a personal touch. We are committed to diversity and inclusion and strive to attract, develop, and retain highly talented employees from diverse backgrounds. Our goal is to benefit from a wide variety of experiences and perspectives.

Equal Opportunity Employer

We are an equal opportunity employer committed to diversity and inclusion. We are committed to creating a workplace where everyone feels valued and respected. We do not discriminate on the basis of age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation.