Scientist II/III - Compendial Testing, Raw Material

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.

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Job Summary

The Scientist II / 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 II / III may also be required to work on method development/method validation projects. For this position, 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).

On-Site Expectations

• 100% on-site position in Morrisville, NC. 
• Five 8 hour shifts: Monday - Friday, 3:00pm - 11:00pm.OR
• Four 10 hour shifts: Wednesday - Saturday, 8:00am - 7:00pm.

Responsibilities

Scientist II:

• 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/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.

Scientist III:

• All Scientist II responsibilities.
• Develops analytical methodology for analysis via HPLC, TOC, UV, and/or particle size.
• Performs GMP review of solutions and wet chemical analyses and chromatography.

Qualifications

• Scientist II: Associate’s Degree and 10 years of related experience or Bachelor’s degree and 4 years of related experience or Master’s degree with 0 years of experience required.
• Scientist III: 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 required or PhD with 0 year of experience. 
• Experience in Pharmaceutical, CDMO, or cGMP preferred.

Knowledge, Skills, and Abilities

• 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 preferred.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.

Travel Expectations

• Up to 5% travel to clients is required.

Physical Demands and Work Environment

The physical demands 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. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to stand. The employee is occasionally required to walk; sit and stoop, kneel, crouch, or crawl. The employee 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 by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts and the risk of electrical shock, burn hazards and microbial contamination. The employee is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.