Analytical Scientist II

Aveva Drug Delivery Systems; Town of Florida (NY); On-site; USD 60,000 - 90,000; Full time

Job summary

Aveva Drug Delivery Systems is seeking a laboratory professional to develop and validate analytical methodologies supporting pharmaceutical projects. The role involves testing of drug products and components under cGMP guidelines and general supervision.

Responsibilities include applying HPLC, GC, UV-VIS and other instrumentation, performing stability testing, and ensuring accurate documentation in line with SOPs and safety requirements.

Qualifications

• Bachelor's degree in chemistry or related field is required.
• Master's degree preferred; MS or higher is advantageous.
• Experience in analytical laboratory methods and validation is desirable.
• Familiarity with compendial pharmacopeia and regulatory guidelines.

Responsibilities

• Proficient in analytical testing of APIs and excipients using validated methods.
• Perform stability testing for GMP and R&D finished products.
• Develop and validate analytical methods; transfer methods with limited supervision.
• Maintain accurate laboratory records and document experimental data.
• Follow SOPs and safety regulations; ensure compliance with regulatory requirements.
• Communicate data and issues to supervisors promptly.

Skills

Instrumentation proficiency

cGMP knowledge

Data analysis

English writing and communication

Education

B.S. in chemistry or related field

M.S. degree

Tools

HPLC

GC

UV-VIS

Dissolution testing

pH measurement

Titration

Job description

Description

Job Summary: Laboratory position which involves development and validation of analytical methodology in support of the research projects involving testing of pharmaceutical components and/or drug products. Under general supervision, the position may require proficiency in support formulation, development method improvement and validation, testing per compendial pharmacopeia, etc.

Job Responsibilities

• Proficiency in multiple instrumentation techniques such as HPLC, GC, UV-VIS, dissolution equipment, pH measurement, titration, etc.
• General knowledge of cGMP and FDA requirements.
• Perform stability testing for GMP and R&D finished products
• Conduct analytical testing of API, excipients and components following compedial and validated methods
• Perform analytical method validation and method transfer with a minimum supervision.
• Follow company’s SOPs, STPS and comply with safety regulations.
• Maintain detailed record of experiments in the laboratory notebook.
• Timely communicate to supervisor(s) the obtained data and any issues aroused during testing
• Ability to analyze and interpret the analytical data under minimum supervision.
• Interpret specifications, standard operating procedures, and standard testing procedures.
• Writes/reviews protocols, reports, SOPs and STPs applicable to analytical laboratory under the supervision.
• Works as a member of a team to achieve all outcomes
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
• Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion
• All other relevant duties as assigned

Qualifications

Job Requirements

Education

• Bachelor’s degree (B.S.) in chemistry or related field
• Master’s degree (M.S.)

Knowledge, Skills and Abilities

• General statistical applications such as normal ant T-test distribution, regression analysis, determination of test reliability and validity, analysis of variance, correlation techniques
• Analytical chemistry and common instrumentation
• General understanding of HPLC, GC, Drug Release, UV, IR, Titration.
• Using common computer software and analytical applications programs.
• Writing and interaction in English

Experience

• At least two (2) to five (5) years experience in pharmaceutical laboratory (B.S)
• At least zero (0) to three (3) years experience (M.S.)