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Associate Scientist

Eingestellt von Synectics

Gesuchte Skills: Support, Sales

Projektbeschreibung

RESPONSIBILITIES:

- Develops, directs, and performs lab activities related to experiments, studies, and projects in support of production, laboratory, or other groups.
- Researches sufficient information from all sources to fully understand study and needs.
- Uses proper study design to effectively utilize resources to accomplish objectives
- Plans studies, including timeline to follow and strategy in alignment with project objective
- Compiles, analyzes, and interprets data leading to reports with conclusions and recommendations to appropriate personnel
- Understands and follows GMP/GLP regulations.
- May supervise non-exempt and contract personnel to achieve above goals.
- Will work with senior scientific or management staff on major studies assuming scientific and GMP responsibility for a portion or portions of the study. Includes cross functional and cross site teams
- Keeps abreast of technological advances specific to the laboratory and adopts and develops new techniques or scientific methods based on findings.
- Provides instrumentation support for maintenance and troubleshooting.
- Develops and Manages the PM program for laboratory instrumentation.
- Provides support and coaching for technology and method transfers
- Maintains Standard Operating Procedures and recommends/validates/qualifies new methods and procedures for the laboratory.
- Provides recommendations, conclusions and direction based on the data obtained from studies.
- Completes Validation/Qualification methodology process reviews/verifications with support of compliance and/or re-validation requirements.
- Provides support on all IOQ/PQs for laboratory instrumentation including document generation and IOQ/PQ completion.
- Serve as Systems Administrator for Laboratory Computer systems, ie Empower 3, Omnic, LIMS.
- Maintains a safe and clean working area.
- Ability to communicate within department, with vendors, contractor sites and/or external customers for administrative and technical information.
- Ability to prepare reports of experiments or studies that are grammatically and technically ready for regulatory audit.
- Ability to construct and format reports for the intended audience (ie FDA, Production, Laboratory, Customers, or Sales).
- May support FDA filings, assisting in compiling FDA responses, annual compliance reports, provide review for regulatory submissions.
- May support release of API and finished goods including technical review of laboratory records, and COA generation and/or approval.

REQUIREMENTS:

- BS or higher in related scientific field.
- Approximately 5-10 years laboratory experience preferably in an FDA regulated environment.

SKILLS:

- Excellent attention to detail, excellent written and verbal skills.
- Proficient in chemistry and analytical instrumentation including but not limited to HPLC, IC, GC, FTIR and UV-VIS spectroscopy.
- Experience with Wet Chemistry bench methods.
- Ability to troubleshoot issues as it relates to methods and equipment/instruments.
- Experience with analytical method development and validation.
- Ability to develop, run/direct, and report experiments, studies, and projects in support of laboratory, customer, validation, production, or other groups.
- Experience with instrumental software, ie, Empower Chromatography Data System, Omnic Administrative Duties. Responsible for identifying and trending data.
- Computer literate with MS Excel, Word, Access and PowerPoint
- Must have 5 - 10 years experience
- FDA Regulations

Projektdetails

  • Einsatzort:

    West Virginia, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Marketing/Vertrieb, Sonstiges

  • Skills:

    support, sales

Synectics