The Analytical Associate Scientist performs analytical routine and non-routine testing in support of pharmaceutical product development or pharmaceutical manufacturing. May also be required to work on method development/method validation projects. Typical types of testing: assays (potencies, related substances, residual solvents, metals etc.), rate of release (dissolution), moisture content, identification, and various other wet chemistry based measurements. HPLC 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). Ability to efficiently organize the routine work with minimum supervision and to properly evaluate and interpret generated data is required. Detailed understanding of the theoretical basis of the methods/experiments along with ability to troubleshoot equipment is also required. Helps maintain broad knowledge of state-of-the-art principles and theories in chemistry. May participate in scientific conferences and contributes to scientific journals. Maintains a high level of professional expertise through the familiarity with scientific literature. May be required to write client reports. May provide support in corporate research and development of patent applications. Uses professional concepts to contribute to the development of company concepts and principles and to achieve objectives in creative and effective ways. Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Demonstrates working knowledge of scientific principles. May determine methods and procedures on new assignments and may provide guidance, mentoring and training to other personnel. May interact with clients and participate in FDA and/or client audits.
Key Job Responsibilities:
? Maintains advanced knowledge of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks.
? Performs advanced technical assignments with understanding of underlying scientific principles.
? Analyzes and interprets information for technical correctness and accuracy.
? Provides basic technical problem solving assistance applying appropriate scientific procedures.
? Complies with applicable GMPs, peer checks information, and signs for GMP review.
? Approves instrument or production documentation and standard operating procedures.
? Evaluates and makes recommendations with regard to aberrant information.
? Participates in company sponsored training and maintains current status of certifications.
? Provides technical training and leadership for subordinate technical positions.
? Maintains productive work ethic.
? Demonstrates company loyalty in relations with Company personnel and clients.
? Maintains a safe, clean, and organized work environment free of safety hazards.
? Enters project hours promptly and updates project status on appropriate tracking and/or timekeeping systems.
? Suggests improvements for safety, work quality, and productivity.
? Works the hours necessary to meet scheduling commitments; is punctual with low absenteeism.
? Provides technical presentations within the company.
Essential Job Requirements:
BS/BA degree in scientific related field with 6 - 9+ years related experience or Masters with 0 - 2+ years related experience.
? Chromatography (i.e. HPLC, GC).
? Spectroscopy (i.e. UV, IR, AA).
? Titronics (i.e. KF).
? General Lab Techniques (i.e. extractions).
? GLP/GMP Policies and Regulations.
? Extensive knowledge of chemistry and scientific calculations.
? Wet Chemistry.
? Technical Writing.
? Extensive lab skills (equipment usage, terminology, etc.).
? Method Validation.
? Method Development.
Supervision Received: General
Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. Acts independently to determine methods and procedures on new assignments. May seek management direction for problems of diverse and/or complex scope.
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 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.
Environment and Protective Equipment:
The work environment characteristics described here are representative of those an employee encounters while performing 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 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, lab coats, full protective body coverings, various types of gloves, etc.