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Senior Research Associate Job
Eingestellt von Yoh
Gesuchte Skills: Engineering, Support
Projektbeschreibung
THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:
- HPLC, Aerosol methods, UV-VIS.
- Experience with protein, peptides
- A minimum of eight (8) years work experience in a pharmaceutical or biotechnology
- Bachelors degree
- Karl Fischer, DSC, TGA, XRD
- knowledge of current GMPs
WHAT YOU'LL BE DOING:
- Support preformulation, formulation, analytical method development and product characterization using a variety of analytical methods with a focus on HPLC and aerosol analysis for the company's proprietary dry powder inhaler products based on particle engineering technology.
- This position includes laboratory analysis and peer review of documents to meet the Quality and GMP/GLP requirements.
- 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.
- 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.
WHAT YOU NEED TO BRING TO THE TABLE:
- Must have excellent analytical skills, with significant hands on laboratory experience.
- Must have a demonstrated working knowledge of scientific principles.
- Must be able to independently write reports.
- Must be able to demonstrate sound judgment within broadly defined practices and policies.
- Good computer skills are required. Working knowledge of MS word, Excel, Powerpoint is a plus.
- Must be able to provide technical assistance to others in a wide range of laboratory based activities/techniques.
BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:
- 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.
- Product development or QC experience.
- Experience with Physico-chemical characterization of Pharmaceutical products, with emphasis of HPLC and wet chemistry techniques (eg, UV-VIS)
- Knowledge of GMPs, regulatory guidelines and good documentation/laboratory practices.
RECRUITER: Mary Nguyen
Yoh, a DayJ2W: CLINICAL; MONJOB
TAX TERM: CON_W2J2WPACNW
Ref:
SFSF: LS
Projektdetails
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Einsatzort:
San Carlos, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges