Senior Analytical Scientist

Altasciences; Harleysville (PA); Sur place; USD 110 000 - 160 000; Plein temps

Avantages offerts par ce poste

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

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Analytical method development

Method qualification

Regulatory submissions

GLP/GMP experience

Mentoring

Cross-functional collaboration

ICH guidelines

Formation

Bachelor’s in Engineering or Chemistry

Master’s or PhD preferred

Outils

HPLC/UPLC

Analytical instrumentation

Data visualization

Office software (Word, Excel)

Description du poste

Your New Company!

At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you’re a recent college graduate or seeking your next career opportunity, it’s time to discover your future at Altasciences.

We are better together and together We Are Altasciences.

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.

What You’ll Do Here

• 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.

• Ensures 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.

What You’ll Need to Succeed

• 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.

What We Offer

Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

Altasciences’ Benefits Package Includes:

• 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

Altasciences’ Incentive Programs Include:

• Training & Development Programs
• Employee Referral Bonus Program

MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH

Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences!