Analytical Scientist III

Aveva Drug Delivery Systems Inc; Florida; On-site; USD 80,000 - 120,000; Full time

Job summary

Aveva Drug Delivery Systems Inc in Florida is seeking a Laboratory Scientist to develop and validate analytical methods for pharmaceutical components and drug products. You will design experiments, analyze data, and provide scientifically sound recommendations to support research projects.

Responsibilities include writing protocols, reports, SOPs, and supporting regulatory submissions, while maintaining GMP compliance and training junior staff.

Qualifications

• BS in chemistry or related field required.

Responsibilities

• Develop and validate analytical methods for APIs and drug products.
• Execute experiments and interpret data to support development.
• Prepare protocols, reports, and regulatory submissions (ANDAs/NDA).
• Train junior scientists and QC staff.
• Maintain laboratory instrumentation and safety compliance.

Skills

Analytical chemistry

HPLC/LC-MS/MS

Data analysis

Documentation writing

Problem solving

Regulatory compliance

Instrument maintenance

Communication

Team training

Education

Bachelor’s degree in chemistry or related field

Master’s degree or Ph.D.

Tools

HPLC

GC/GC-MS

LC-MS/MS

UV/Vis spectrophotometry

IR spectrophotometry

Dissolution apparatus

TrackWise

Empower

MS Office

Job description

Job 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 ResponsabilitiesDeveloping new analytical methods using innovative solutions for actives, excipients, drug release, residual solvents and to support product development.Validating analytical methodologies following ICH guidanceExecuting 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 tasksImproves analytical applications by implementing new analytical techniquesClearly 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 outcomesOperates 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 PassionAll other relevant duties as assignedJob RequirementsEducationBachelor’s degree (B.S.) in chemistry or related fieldMaster’s degree (M.S.)or Ph.D.Knowledge, Skills and AbilitiesProficiency 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 informationOrganization 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.ExperienceAt least five (5) years experience in pharmaceutical laboratory (B.S)At least two (2) years laboratory experience (M.S.)