Altasciences

Pharmaceutical

SeniorAnalyticalScientist

Harleysville, Pennsylvania, United States FULL TIME
The Brief

“Senior Analytical Scientist at Altasciences. Skills: analytical method development, method validation, drug development, quality assurance. Design analytical approaches. Manage analytical approaches”

What You'll Achieve.

get them faster to people who need them; significant impact on health and well-being; high-quality data generation; reproducibility; clear conclusions; guide future work; alignment with global standards; achieve successes

Industry & Context.

Pharmaceutical
Problems you'll solve

solution oriented; Independent thinker; proactive mindset

What They're Looking For.

Must Have

Bachelor’s in Engineering, Chemistry, Pharmaceutical Sciences or related field, 8+ years of current industry experience in analytical method development and qualification, Experience in modern dissolution method development and IVIVC, Demonstrated history of applying current ICH/USPP/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, 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, knowledge of laboratory CGMP regulations (FDAA), 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 Have

Master’s or PhD preferred, 5+ years with Master’s or 3+ years with PhD

What You'll Do.

Design analytical approaches

Manage analytical approaches

Oversee analytical studies

Review analytical studies

Lead method development

Lead method qualification

Lead method validation

Ensure high-quality data

Ensure data reproducibility

Collaborate to apply techniques

Ensure methods follow ICH principles

Evaluate scientific data

Draw clear conclusions

Contribute to regulatory submissions

Author quality modules

Work with Formulation Development

Work with manufacturing

Work with quality teams

Select analytical techniques

Apply analytical techniques

Lead projects end to end

Mentor junior scientists

Develop new technologies

Implement new technologies

Develop high-throughput workflows

Implement high-throughput workflows

How You'll Work.

Team & Collaboration

Collaborate cross-functionally; Work with Formulation Development, manufacturing, and quality teams; Collaborative work environment; Team-based environment

Communication Scope

presentation abilities; communication abilities; interpersonal skills; facilitation skills

Process & Methodology

Manage multiple projects

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