Analytical Scientist III

Aveva Drug Delivery Systems; Town of Florida (NY); On-site; USD 85,000 - 90,000; Full time

Job summary

Aveva Drug Delivery Systems in Miramar, FL is seeking a laboratory scientist to develop and validate analytical methods supporting pharmaceutical projects. The role involves designing experiments and providing scientifically sound recommendations based on data.

You will validate methods per ICH, execute complex experiments, and train junior staff while upholding GMP, safety, and ethical standards. This position offers a competitive salary and growth opportunities.

Qualifications

• Bachelor’s degree in chemistry or related field.
• Master’s degree or Ph.D.
• Experience with analytical instruments and method development.

Responsibilities

• Develop analytical methods for actives, excipients, drug release, and to support product development.
• Validate analytical methodologies following ICH guidance.
• Execute complex experiments in R&D for development and validation of processes.
• Identify creative solutions for non-routine analytical tasks.
• Improve analytical applications by implementing new techniques.
• Interpret data to make scientific judgments and take corrective actions.
• Write/review protocols, reports, SOPs, specifications & test procedures.
• Prepare documentation to support regulatory submissions (ANDAs/NDAs).
• Adhere to GMP, SOPs, and safety rules; maintain instrumentation.
• Train junior scientists and QC chemists as necessary.
• Demonstrate problem solving and provide recommendations.
• Work as part of a team to achieve outcomes.
• Comply with Code of Conduct and regulatory requirements.
• Support company values: Collaboration, Courage, Perseverance, and Passion.

Skills

Analytical method development

ICH/Regulatory knowledge

Data interpretation

Team collaboration

Experimental design

Education

Bachelor's degree in chemistry

Master's degree

Ph.D.

Tools

HPLC

GC

LC-MS/MS

UV/Vis & IR spectrophotometry

Dissolution apparatus

Job description

Job DetailsJob Location: Miramar, FL 33025Salary Range: $85,000.00 - $90,000.00 Salary/yearJob Shift: AnyJob Summary:

Laboratory position which involves development and validation of analytical methodology in support to the research projects involving testing of pharmaceutical components and/or drug products. This position also involves designing and completion experiments and providing scientifically sound recommendations based on the data obtained.

Job Responsabilities

• Developing new analytical methods using innovative solutions for actives, excipients, drug release, residual solvents and to support product development.
• Validating analytical methodologies following ICH guidance
• Executing complex experiments in support to R&D for development and validation of process under minimum supervision.
• Ability to identify creative and innovative solutions of non routine analytical tasks
• Improves analytical applications by implementing new analytical techniques
• Clearly interpret problems, make scientific judgment based on outcome of the obtained data and take appropriate actions to resolve the issues.
• Writing/reviewing protocols, reports, SOP’s, specifications & test procedures.
• Compiling necessary documentation to support regulatory submissions such as Abbreviated New Drug Applications (ANDAs) or New Drug Applications (NDA), as required.
• Adhering to laboratory SOP guidelines, GMP requirements and safety rules.
• Maintaining analytical instrumentation through the proper performance and/or maintenance as required.
• Train junior scientists and QC chemists as necessary.
• Demonstration ability of problem solving and offer necessary recommendations.
• 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

QualificationsJob Requirements

Education

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

Knowledge, Skills and Abilities

• Proficiency in using analytical equipments such as UV/Visible and Infrared spectrophotometers, automatic titrators, pH potentiometers, dissolution apparatus, HPLC, GC, GC/MS, LC/MS/MS and other techniques as needed.
• Strong verbal and written communication skills, interpretation of experimental results, technical protocols and reports writing.
• Broad knowledge of methods development in support Active Pharmaceutical Ingredients, Intermediates, excipients and drug products.
• Ability to clearly indentify problems and take appropriate actions based on available information
• Organization skills and ability to plan and prioritize work to meet deadlines.
• Proficiency in the use of computer hardware, software and databases such as Word processing software, MS office, TrackWise, Empower, or other applicable to analytical instrumentation software.
• Demonstrate accuracy and thoroughness of work and adhere to high quality standards related to cGMPs.

Experience

• At least five (5) years experience in pharmaceutical laboratory (B.S)
• At least two (2) years laboratory experience (M.S)