Job Summary
The Scientist II 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 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.
- 1st Shift: Monday - Friday, 8:00am - 5:00pm.
Responsibilities
- Develops analytical methodology for analysis via HPLC, UV, KF, and/or particle size.
- 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/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.
Qualifications
- Associate’s degree and 10+ years of related experience.
- Bachelor’s degree and 4+ years of related experience.OR
- Master’s degree with 0+ years of related experience.
- Experience in Pharmaceutical, CDMO, or cGMP required.
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 required.
- Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.
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. While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is occasionally required to walk, sit, climb, or balance 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 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. 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, half face and full-face respirator, lab coats, full protective body coverings, various types of gloves, etc.
