Analytical Scientist II

Aveva Drug Delivery Systems; Florida; On-site; USD 70,000 - 80,000; Full time

Job summary

Aveva Drug Delivery Systems in Miramar, FL is seeking a laboratory analyst responsible for developing and validating analytical methods to support pharmaceutical projects. The role involves testing drug components and products and following cGMP and regulatory expectations.

Under supervision you will perform method development, validation, and testing with instrumentation such as HPLC, GC, UV-Vis, dissolution, and pH measurement, and document results and SOPs.

Qualifications

• Bachelor's degree in chemistry or a related field
• MS degree preferred for MS holders
• Experience in pharmaceutical lab required
• Knowledge of regulatory requirements (cGMP/FDA)

Responsibilities

• Proficiency in instrumentation such as HPLC, GC, UV-VIS, dissolution equipment, pH measurement, titration.
• 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 minimal supervision.
• Follow company’s SOPs, STPS and comply with safety regulations.
• Maintain detailed records of experiments in the laboratory notebook.
• Timely communicate data and issues to supervisors during testing.
• Ability to analyze and interpret analytical data under minimal supervision.
• Interpret specifications, SOPs, and testing procedures.
• Writes/reviews protocols, reports, SOPs and STPs applicable to analytical laboratory under supervision.
• Works as a team member to achieve all outcomes.
• Operate in accordance with Code of Conduct and Safety requirements.
• Performs all work in support of values: Collaboration, Courage, Perseverance, and Passion
• All other relevant duties as assigned

Skills

Statistics

Analytical chemistry

HPLC

GC

UV-Vis

Titration

Drug Release

Software basics

English writing

Education

Bachelor's degree in chemistry

Master's degree

Job description

Job Details: Job Location: Miramar, FL 33025, Salary Range: $70,000.00 - $80,000.00 Salary/year, Job Shift: Day, 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.)