Alcami Corporation · 6 hours ago
Sr. Scientist I - Analytical Testing (Chromatography)
Alcami Corporation is dedicated to delivering reliable solutions for transformative medicines, supporting clients from discovery to commercialization. The Senior Scientist I will perform analytical testing in pharmaceutical product development, utilizing various methodologies such as HPLC and GC, while ensuring compliance with cGMP standards.
Pharmaceuticals
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
Qualification
Required
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
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
Preferred
CDMO experience is preferred
Chromatography (i.e. GC, HPLC) is highly preferred
Company
Alcami Corporation
Alcami is a US-based contract development and manufacturing organization headquartered in NC with 45+ years of experience advancing pharmaceuticals and biologics from development to delivery.
Funding
Current Stage
Late StageCompany data provided by crunchbase