Analytical Chemist

Title: Analytical Chemist

Full Time

Location: Scottsdale, AZ

Our Company

Bright Path Laboratories, Inc. is a niche generic pharmaceutical company specializing in injectables. Our priority is to deliver high-quality, innovative and cost-efficient generic pharmaceutical drugs to hospitals and pharmacies.

Position Summary
The Analytical Scientist is responsible for methods and process development for our Injectable ANDA’s. You will develop and validate new analytical methods, conduct stability studies and perform sample testing to support regulatory submissions. This testing includes: Instrumental analysis such as HPLC, GC, UV and FTIR as well as wet chemistry such as titrations, LOD and chemical identification tests.

Role Responsibilities

• Perform analytical testing of materials, finished product, and components. This testing will consist of wet chemistry and analytical chemistry techniques.
• Responsible for analysis of test methods by HPLC, GC, GC/MS and other method.
• Must be proficient with laboratory instrumentation such as HPLC, GC, FTIR, and UV-Vis.
• Perform routine maintenance of analytical instruments.
• Provide analytical support to formulation group in order to finalize the formulation composition and components for new products.
• Prepares standard volumetric solutions and reagents used in testing
• Perform critical interpretation of analytical data.
• Execution of mathematical calculations as outlined in test methods.
• Assess data to determine if the material tested meets its specifications.
• Peer review and approval of raw data.
• May write and review SOPs, Validation Protocols, Quality Protocols, Test Methods, and Specifications.
• Clear (legible), accurate, and complete documentation of test activities on approved worksheets and laboratory notebooks.
• Able to manage and track assigned projects.
• Perform Extractable/leachable studies for container closure systems of drug products
• May be assigned to general laboratory duties.
• Maintain compliance with required training.

Additional Responsibilities:

• Analytical testing is done with precision, accuracy and completed on time.
• Shows ability to train new employee chemists.
• Performs pre-formulation laboratory experiments and studies.

Required Qualifications

Motivated, independent and team worker, with effective communication, documentation, writing and problem-solving skills. Ability to perform assigned tasks in multi-disciplinary environment – process, manufacturing, analytical, and basic R&D Strong computer skills including Microsoft Word and Excel.

Experience and Education

• MS in a scientific discipline with a minimum of 2 years experience, or
• BS/BA in a scientific discipline with a minimum of 4 years of experience.
• For API: experience in HPLC is required. Experience in one of the following GC, particle size, wet chemistry, and DSC/TGA is preferred.
• Must have experience or demonstrated ability working with little supervision.
• Background check required.
• *If the candidate has an advanced degree in chemistry, the experience requirement may be waived.

Travel Requirements

• 0-5% Travel required for this role

Physical Demands and Work Environment:
Regular (50% - 69%) exertion including standing/walking for extended periods of time, lifting/carrying more than 15 and up to 25 pounds, works with chemicals and wears basic personal protective equipment (PPE) (glasses, gloves, ear protection), and restrictive PPE (tyvek suits, respirators), operates lab instruments. At times low physical effort includes sitting, and operating computers or other small equipment.

DISCLAIMER: The list under Role Responsibilities are not exhaustive, but are merely the most accurate lists for the current job. Management reserves the right to revise the job description and to require that other tasks be performed when the circumstances of the job change.