A

Altasciences

Integrated CRO for early-phase drug development

Senior Analytical Scientist

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeHarleysville, PA, USANo salary listedIn-person

About the Job

Requirements

  • A bachelor's degree in Engineering, Chemistry, Pharmaceutical Sciences, or a related field is required; a master's degree or PhD is preferred.
  • At least 8 years of current industry experience in analytical method development and qualification with a bachelor's degree, 5 years with a master's degree, or 3 years with a PhD.
  • Experience in modern dissolution method development and in vitro-in vivo correlation (IVIVC).
  • A demonstrated history of applying current ICH, USP, BP, EP, and JP guidance toward regulatory submissions.
  • Proficiency with Microsoft Word, Excel, Outlook, and scientific software.
  • Extensive hands-on experience with quantitative tests including assay, content uniformity, dissolution, particle size distribution, preservative assay, related substances, residual solvents, resuspendability, viscosity, and other techniques for testing drug product oral solid dosage forms, plus data review in a pharmaceutical development and quality control laboratory setting.
  • Familiarity with analytical techniques including HPLC/UPLC, disintegration testing, and compendial or generic testing such as UV, Karl Fischer, and titrations.
  • Proficiency in analytical instrumentation and troubleshooting.
  • Experience in a regulated laboratory environment, such as GLP/GMP.
  • Experience with multiple dosage forms, such as solid oral products, peptides, sterile products, biologics, or specialized manufacturing.
  • Strong knowledge of laboratory cGMP regulations (FDA/EMA) and pharmaceutical quality systems.
  • Ability to manage multiple projects in a fast-paced setting.
  • Ability to take initiative to identify and anticipate client needs and make implementation recommendations.

Responsibilities

  • Design and manage analytical approaches for early drug development projects in R&D, preclinical, and Phase I clinical stages, focusing 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.
  • Lead development, qualification, validation, and transfer of analytical methods to ensure high-quality data generation and reproducibility.
  • Collaborate across functions to identify and apply 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 to ensure high-quality, reproducible data.
  • Evaluate scientific data, draw conclusions, guide future work, and communicate findings through presentations, technical reports, and other media.
  • Author relevant quality-module sections for regulatory submissions in alignment with global standards.
  • Work with formulation development, manufacturing, and quality teams to select and apply analytical techniques.
  • Lead analytical method development projects from start to finish.
  • Develop and implement analytical technologies and high-throughput workflows.

Desired Qualifications

  • A master's degree or PhD.
  • Demonstrated ability to mentor team members.
  • A proactive, solution-oriented, results-oriented approach and people-based leadership behavior.
  • Attention to detail and diligence.
  • Strong presentation and communication abilities.
  • Interpersonal and facilitation skills.
  • Ability to work in a collaborative, team-based environment.
  • Self-direction, motivation, and willingness to take initiative.

About the Company

Altasciences

Integrated CRO for early-phase drug development

Altasciences provides integrated early-stage drug development services, covering preclinical testing, early clinical trials, and contract manufacturing. It functions as a single, in-house CRO that coordinates discovery support, safety testing, clinical research, and manufacturing to streamline a program from start to early proof of concept. The company differentiates itself by offering an end-to-end, one-stop path rather than requiring clients to contract multiple vendors. Its goal is to help innovator programs move quickly and efficiently through early development to speed up decision making and progression to later-stage trials.

Company size
1,001-5,000
Company stage
Early VC
Total funding
$6.7M
Headquarters
Laval, Canada
Founded
1976

Recently Posted Jobs

Explore more opportunities at Altasciences

See more jobs