Scientist III - Analytical , Compendial , Raw Material Testing - Weekend 1st Shift

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise, and proven regulatory track record.

About the role

The Scientist III is accountable for driving results in a fast-paced environment by performing analytical routine and non-routine testing in support of pharmaceutical product development or pharmaceutical manufacturing. The Scientist III may also work on method development and method validation projects. Common methodologies include HPLC, dissolution, GC, titrations, UV-Vis, AA, and IR. Test methods may be compendial (e.g., USP, EP) or proprietary.

Schedule

• 100% on-site position
• 1st Shift: Friday - Sunday, 7:00 AM - 7:00 PM

Responsibilities

• Develops and performs routine analytical analysis via HPLC, TOC, UV, and/or particle size based on various compendia
• Performs GMP review of solutions and wet chemical analyses and chromatography
• Performs one or more of the following techniques: residual solvents, assays (potencies, related substances), dissolution, elemental impurities, moisture content, identification, and various other wet chemistry-based measurements
• Evaluates and interprets generated data
• Analyzes information for technical correctness and accuracy
• Understands the theoretical basis of methods and experiments
• Solves problems of diverse scope in which analysis of data requires evaluation of identifiable factors
• Writes test procedures, protocols, and reports
• Maintains working knowledge of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks
• Assists in removal of hazardous waste, routine equipment cleaning, and restocking of consumable products and reagents
• Effectively uses various laboratory software packages (Empower3, ProCal, Master Control, ELN, etc.)
• Maintains a safe, clean, and organized work environment free of safety hazards
• Safely handles potent compounds
• Supervises, handles, or processes hazardous waste under Resource and Conservation guidelines (40 CFR 262.177(a)(7)), including completion of initial and annual RCRA training and familiarity with emergency response procedures
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements
• Other duties as assigned

Requirements

• Associate’s degree and 16+ years of related experience, or
• Bachelor’s degree and 6+ years of related experience, or
• Master’s degree with 2+ years of related experience, or
• PhD with 0+ years of experience
• Experience in Pharmaceutical, CDMO, or cGMP required

Skills

• Demonstrated hands-on experience performing compendial and raw material testing within a pharmaceutical, biotechnology, or CDMO environment
• Strong knowledge of USP, EP, and JP compendial requirements and their application to pharmaceutical raw material and finished product testing
• Excellent verbal and written communication and documentation skills
• Excellent detail orientation and organizational skills
• Excellent problem-solving and basic trouble-shooting ability
• Excellent knowledge of laboratory equipment and safety
• Expert knowledge of laboratory documentation
• Working knowledge of cGMP in a pharmaceutical or regulated environment preferred
• Proficiency with Microsoft Office (Word, Excel, PowerPoint)

Travel Expectations

Up to 5% travel to clients is required.

Physical Demands and Work Environment

• Regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear; and smell
• Frequently required to stand
• Occasionally required to walk; sit; stoop, kneel, crouch, or crawl
• Must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, and occasionally lift and/or move up to 50 pounds
• Specific vision abilities required include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus
• Frequently exposed to moving mechanical parts and risk of electrical shock, burn hazards, and microbial contamination
• Occasionally exposed to fumes or airborne particles, toxic or caustic chemicals, and vibration
• Noise level in the work environment is usually moderate
• Required to wear appropriate personal protective equipment (e.g., safety eyewear, respirators, lab coats, gloves, full protective body coverings)