Analytical Scientist III
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AVEVA DRUG DELIVERY SYSTEMS INC
FL
Summary
The Analytical Scientist III will develop and validate analytical methodologies for pharmaceutical products while ensuring compliance with ICH and GMP standards. They are responsible for executing complex experiments, interpreting data, and preparing documentation for regulatory submissions like ANDAs and NDAs.
Job Description
Job Details: Job Location: Miramar Aveva - Miramar, FL, Salary Range: $85000.00 - $90000.00Salary/year, Job Shift: Any, 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 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
Qualifications: Job 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.)
AVEVA is a global leader in transdermal drug delivery located in the United States. The company has an extensive history of providing pharmaceutical partners with fully integrated, controlled-release transdermal products that fulfill unmet market needs or supply high-quality, affordable brand equivalents. By leveraging this experience, AVEVA offers a full range of research, development and manufacturing capabilities to produce transdermal pharmaceutical products that can improve the quality of life, usage and compliance rates for patients.
Founded
2003
Company size
201-500 employees
Industry
Pharmaceutical Manufacturing
Org type
Privately Held
Headquarters
Miramar, FL
AVEVA is a global leader in transdermal drug delivery located in the United States. The company has an extensive history of providing pharmaceutical partners with fully integrated, controlled-release transdermal products that fulfill unmet market needs or supply high-quality, affordable brand equivalents. By leveraging this experience, AVEVA offers a full range of research, development and manufacturing capabilities to produce transdermal pharmaceutical products that can improve the quality of life, usage and compliance rates for patients.
Founded
2003
Company size
201-500 employees
Industry
Pharmaceutical Manufacturing
Org type
Privately Held
Headquarters
Miramar, FL