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Jobs · Analyst · North Carolina

Scientist II - Biotech- CE, icIEF, HPLC

Alcami Corporation · Durham, NC · 3 wk ago
AnalystFull-time

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 a proven regulatory track record.

About the role

The Scientist II is accountable for driving results in a fast-paced environment by performing analytical-biotech routine and non-routine testing in support of pharmaceutical product development or pharmaceutical manufacturing. The Scientist II may also work on method development and method validation projects. Common methodologies include HPLC, CE, icIEF, UV, cKF/KF, pH, and osmolality. Test methods may be compendial (e.g., USP, EP) or proprietary (client-supplied or developed by Alcami).

Responsibilities

  • Develops, validates, and transfers analytical methodology for analysis via HPLC (SEC, AEX, CEX), UV, CE, and icIEF.
  • Performs GMP review of solutions and wet chemical analyses and chromatography.
  • Performs analysis of large molecule and biologic samples to assess purity, potency, identity, and product quality attributes.
  • 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

  • Master’s degree in Chemistry, Biochemistry, or related field with 0+ years of related work experience.
  • Bachelor’s degree in Chemistry, Biochemistry, or a related field with coursework in Chemistry and 4+ years of related work experience.
  • Associate’s degree in Chemistry or related field with 10+ years of related experience.

Skills

  • Excellent verbal and written communication and documentation skills.
  • Strong detail orientation and organizational skills.
  • Strong problem-solving and basic troubleshooting ability.
  • Strong knowledge of laboratory equipment and safety.
  • Strong knowledge of laboratory documentation.
  • Strong knowledge of cGMP in a pharmaceutical or regulated environment (preferred).
  • Proficiency with Microsoft Office (Word, Excel, PowerPoint).

Schedule

100% on-site position. 1st Shift: Monday - Friday, 8:00 AM - 5:00 PM.

Travel Expectations

Up to 5% travel required.

Physical Demands and Work Environment

The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear; and smell.
  • Occasionally required to walk, sit, climb or balance, and 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.
  • Occasionally exposed to wet and/or humid conditions; moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock; and vibration.
  • The noise level in the work environment is usually moderate.
  • Required to wear appropriate personal protective equipment (PPE), which may include safety eyewear, respirators, lab coats, full protective body coverings, and gloves.

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