Senior Research Associate

Job Description

Job Purpose:

• As part of the Product Development/Analytical group this position will support preformulation, formulation, analytical method development and product characterization using a variety of analytical methods with a focus on HPLC and aerosol analysis for client's proprietary dry powder inhaler products based on particle engineering technology.

• This position includes laboratory analysis and peer review of documents to meet the client Quality and GMP/GLP requirements. The SRA will interact with various functional/technical groups in Development, QA/QC and CMC teams supporting the clinical development of products.

The senior research associate (SRA) will be responsible for coordination, collection, processing of data under minimal supervision and guidance and write-up of protocols and reports.

• Expertise in chemical analysis of small molecule formulations with an emphasis on HPLC, Aerosol analysis using Cascade Impactors, UV-VIS and GC, as well as their operation, maintenance and trouble-shooting is required. Experience with protein, peptides, and solid state characterization techniques such as Karl Fischer, DSC, TGA, XRD is a plus.

• Experience working in an FDA regulated environment and knowledge of current GMPs as they apply to laboratory practices are a must. Experience working with dry powder inhalers (DPIs), metered dose inhalers (MDIs), nebulizers and nasal sprays is a plus.

• The candidate should be able to demonstrate success in technical proficiency, scientific creativity, collaboration with others, independent thought, troubleshoot, interpret results, ability to manage time and multi-task.

• The candidate should be current in field, while able to demonstrate expert knowledge in scientific principles and concepts. The candidate must be able to clearly communicate scientific information both written and oral with minimal assistance.

• The candidate must be able to demonstrate strong organizational and problem solving capabilities.

• Plan, conduct and coordinate experiments.

• Chemical analysis of small molecule formulations with an emphasis on HPLC, Aerosol methods, UV-VIS.

• Physicochemical characterization of formulated powders using an ensemble of powder characterization, solid state and aerosol techniques.

• Analytical method development and validation to support clinical development.

• Independently executes technical experiments and develops methods following appropriate laboratory/technical procedures.

• Maintains accurate and well-organized laboratory records, worksheets and notebooks.

• Collects, documents, summarizes and disseminate results in both written and oral form.

• Collects and analyzes complex data to prepare technical reports, summaries, protocols, presentations and/or quantitative analyses.

• Acts independently to determine methods and procedures on new assignments and may act as a principal investigator in conducting own experiments.

• Produces competent, reproduce-able results to a high technical standard.

• Makes complex detailed observations and analyzes data to provide an interpretation of results from which recommendations may be made.

Qualifications

A minimum of 8 years work experience in a pharmaceutical or biotechnology research and/or development environment is required.

Must have excellent analytical skills, with significant hands on laboratory experience.

Must have a demonstrated working knowledge of scientific principles.

Must be able to demonstrate good decision-making skills.

Must possess excellent oral and written communication skills.

Must be able to independently write reports.

Must be able to demonstrate sound judgment within broadly defined practices and policies.

Must have demonstrated problem solving abilities.

Strong organizational skills are required.

Good computer skills are required. Working knowledge of MS word, Excel, Power point is a plus.

Experience working in an FDA regulated environment is highly desired.

Must be able to work well in and promote a team environment, and demonstrate leadership abilities.

Must be able to provide technical assistance to others in a wide range of laboratory based activities/techniques.

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Education:

A minimum of a Bachelors degree in a scientific discipline (Chemistry and Pharmaceutical Sciences (preferred)) or Biochemistry, Biology, Chemical Engineering) is required. Equivalent experience may be accepted.

Education background in Biology, Biochemistry or Chemical Engineering will be considered with demonstrated experience and training as an QC, Analytical or Development Scientist.

A development scientist with 8+ year's experience in the Pharmaceutical or Biotech Industry.

Product development or QC experience.

Experience with Physico-chemical characterization of Pharmaceutical products, with emphasis of HPLC and wet chemistry techniques (e.g., UV-VIS)

Knowledge of GMPs, regulatory guidelines and good documentation/laboratory practices.

Additional Information

Best Regards,

Anuj Mehta

9739673402