Sr. Scientist I - Analytical Testing

Alcami Corporation•Durham, NC

10d•Onsite

About The Position

A Senior Scientist I performs analytical routine and non-routine testing in support of pharmaceutical product development or pharmaceutical manufacturing. HPLC, dissolution and/or GC based methodologies are commonly employed in the described testing. Other key methodologies applied include titrations, UV, AA, IR. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company).

Requirements

Bachelor’s degree in Chemistry with 8+ years of experience, or Master’s degree with 4+ years of experience, or Ph.D. with 2+ years of experience required.
2+ years of experience in Pharmaceuticals drug product development under cGMP is required.
Hands-on HPLC experience required.
Excellent verbal and written communication and documentation skills required.
Excellent detail orientation and organizational skills required.
Excellent problem-solving and basic trouble-shooting ability required.
Excellent knowledge of laboratory equipment and safety required.
Expert knowledge of Laboratory Documentation is required.
Ability to develop and implement new methods/processes required.
Ability to plan and manage multiple tasks for timely achievement of results.
Working knowledge of cGMP in a pharmaceutical or regulated environment required.
Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.

Nice To Haves

CDMO experience is preferred.
Experience with Empower software preferred.

Responsibilities

Uses advanced skills in multiple techniques, to include assays (potencies, related substances), dissolution/drug release, residual solvents, elemental impurities, moisture content, identification, and various other wet chemistry-based measurements.
Develops and validates methods, test procedures, protocols, and reports.
Understands the theoretical basis of methods/experiments.
Maintains strong knowledge of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks.
Analyzes information for technical correctness and accuracy.
Evaluates and interprets data.
Achieves results by solving problems of a diverse scope.
Interacts with clients and participates in regulatory agency and/or client audits.
Leads investigations and root cause analysis.
Drives initiatives outside of standard work function.
Maintains a safe, clean, and organized work environment free of safety hazards.
Safely handles potent compounds.
Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
Other duties as assigned.