Description:
The Analytical Research and Development (AR&D) laboratory supports evaluation and testing of raw materials, excipients, APIs, in-process and finished product samples. AR&D also performs development and validation of methods used to support release and stability testing of non-commercial products and materials. The Scientist I, Analytical Research & Development will assist with Development and Validation with some supervision. The Scientist I, Analytical Research & Development will run routine test methods in support of drug substance and drug product sample testing as required.
Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.
The Role
- Analysis of finished products, in-process materials, raw materials, and cleaning verification and validation samples according to the assigned specifications, methods and protocols.
- Preparation of reagents/standards/medias needed for analysis according to methods.
- Safe handling of potent and teratogenic compounds. Disposal of hazardous waste according to environmental regulations and company procedures.
- Tabulation/interpretation of results as recorded in notebooks, reports and logbooks.
- Assures right-first-time execution of departmental methods and SOPs.
- Audits and verifies results, including but not limited to, calculations in notebooks/logbooks and results in reports to check for accuracy and integrity of data.
- Assist with writing and reviewing analytical methods, protocols and SOPs. Supports Material Evaluation Process for new materials if required.
- Other duties as assigned.
The Candidate
- Bachelor’s degree (BS) in a scientific field with 5 plus years’ experience in lab, 3 in GMP required OR
- Master’s degree (MS) in a scientific field with 3 plus years’ experience in GMP lab required OR
- Doctorate in scientific field with 1 plus years’ experience in lab required.
- Experience with common pharmaceutical laboratory techniques such as: UV/VIS, IR and AA Spectroscopy HPLC, UHPLC and GC separations Dissolution, Rupture and Disintegration testing, Expertise in wet chemistry techniques such as titrations, extractions and digestions.
- Knowledge of the following: Safety and hazardous waste requirements, Data acquisition applications and databases, Sound foundations of cGMPs, ICH and USP/EP guidance documents.
- Individual may be required to sit, stand, walk regularly and occasionally lift to 15 pounds; no lifting greater than 44.09 pounds without assistance.
- Vision requirements include ability to differentiate color (Pass the Ishihara Color Vision Screening) and obtain 20/30 acuity in both far and near vision with or without corrective lenses. For Catalent’s in-house screening, the acceptable score is to identify at least 4 of 6 numbers in the circles.