Senior Analytical Scientist

CareAbout•Harleysville, PA

2d•Hybrid

About The Position

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.

Requirements

Bachelor’s in Engineering, Chemistry, Pharmaceutical Sciences or related field.
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.
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.

Nice To Haves

Master’s or PhD preferred.
Experience with multiple dosage forms (e.g., solid oral, peptides, sterile, biologics, or specialized manufacturing).

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.
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.