AR&D Chemist I
Penn Life Sciences · Langhorne, PA · 1 mo ago
AnalystFull-time
Responsibilities
- Perform routine analytical testing of raw materials, in-process samples, stability samples, and finished drug products using approved methods.
- Execute wet chemistry and instrumental analyses in compliance with cGMP, USP, FDA, and ICH requirements.
- Accurately document analytical activities, calculations, and results in laboratory notebooks and electronic systems in accordance with ALCOA+ data integrity principles.
- Support analytical method development, qualification, and validation activities under the guidance of senior AR&D staff.
- Operate, maintain, and perform basic troubleshooting of analytical instrumentation in accordance with SOPs and training authorization.
- Participate in laboratory investigations, deviations, and out-of-specification (OOS) assessments as assigned.
Requirements
- Bachelor’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a closely related scientific discipline required.
- 0–3 years of analytical laboratory experience in a pharmaceutical, biotechnology, or regulated laboratory environment; academic laboratory experience will be considered.
- Working knowledge of analytical techniques such as HPLC/UPLC, UV-Vis spectroscopy, pH, Karl Fischer, TOC, dissolution, or particle size analysis.
- Understanding of good documentation practices and data integrity expectations within a regulated environment.
- Strong organizational, analytical, and communication skills with the ability to manage multiple tasks accurately.
Qualifications
- None specified
Skills
- Strong foundation in analytical chemistry.
- Demonstrated attention to detail.
- Ability to work effectively within a highly regulated pharmaceutical laboratory setting.
Benefits
- 401(k) with company match
- Health, vision, and dental Insurance
- Childcare expense reimbursement
- Tuition reimbursement
- Annual bonus eligibility
- Annual merit increases
- Paid Time Off and Flexible Holidays