Principal Scientist II
: Job Details :

Job Summary:

A Principal 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. A Principal Scientist II will routinely lead method development/method validation projects. 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). Detailed understanding of the theoretical basis of the methods/experiments along with ability to troubleshoot equipment are also required. The incumbent will work on extremely complex problems in which analysis of situations or data requires an evaluation of tangible and intangible variables.

On-Site Expectations:

* 100% on-site position.

* 1st Shift: Monday - Friday, 8:00am - 5:00pm.

Responsibilities:

* Uses advanced skills in multiple techniques: assays (potencies, related substances), dissolution/drug release, residual solvents, elemental impurities, moisture content, identification and various other wet chemistry-based measurements.

* Develops and validates methods, test procedures, protocols and reports.

* Understands the theoretical basis of methods/experiments.

* Maintains strong knowledge of instrumentation, equipment and scientific methodologies necessary to perform assigned tasks.

* Analyzes information for technical correctness and accuracy.

* Evaluates and interprets generated data.

* Achieves results by solving problems of a diverse scope.

* Interacts with clients and participates in regulatory agency and/or client audits.

* Leads investigations and root cause analysis.

* Drives initiatives outside of standard work function.

* 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:

* Bachelor's degree in Chemistry, Biology, or related field with 18+ years GMP related experience; OR Master's degree in related field with 14+ years related experience; OR PhD in related field with 13+ years related 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.

* Ability to develop and implement new methods/processes required.

* Ability to plan and manage multiple tasks for timely achievement of results.

* Working knowledge of cGMP in a pharmaceutical or regulated environment required.

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

Travel Expectations:

* Up to 5% domestic travel.

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 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.