Scientist III - Analytical Testing - Compendial , Raw Material Testing , GMP
About The Position
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. 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 be required to work on method development/method validation projects. For this position, titrations UV, AA, IR methodologies are commonly employed in the described testing. Other key methodologies applied include HPLC, dissolution and/or GC based. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company).
Requirements
- Associate’s degree and 16+ years of related experience.
- Bachelor’s degree and 6+ years of related experience.
- Master’s degree with 2+ years of related experience required or PhD with 0+ year of experience.
- Experience in Pharmaceutical, CDMO, or cGMP 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.
- Working knowledge of cGMP in a pharmaceutical or regulated environment required.
- Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.
Responsibilities
- Develops analytical methodology for analysis via titrations UV, AA, IR, TOC, UV, and/or particle size.
- Performs GMP review of solutions and wet chemical analyses and chromatography.
- Performs one or more of the following techniques: assays (potencies, related substances), dissolution, 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/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.
- This position will be required to supervise, handle, or process hazardous waste under Resource and Conservation guidelines promulgated under 40 CFR 262.177(a)(7), Personnel Training. This includes completion of initial and annual RCRA training and documented as required in Alcami records. This training also includes familiarity with emergency response procedures, emergency equipment, and emergency systems.
- Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
- Other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
