Senior Analytical Scientist

Location: Harleysville

## Senior Analytical Scientist Apply remote type:
On-site locations:
Harleysville, Pennsylvania time type:
Full time posted on:
Posted Yesterday job requisition :
R102641
** 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  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,…