Associate Scientist, Analytical Testing - Genemed - Torrance, CA | Biospace
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Associate Scientist, Analytical Testing - Genemed

Genemed

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Location:
Torrance, CA
Posted Date:
8/30/2017
Position Type:
Full time
Job Code:
Salary:
D.O.E.
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Assay, Assay Development, Assistant, Automation, Biochemistry, Cell Culture, Immunohistochemistry, Immunology,

Job Description

General Position Summary
Analyzes raw and in-process materials and final products utilizing IHC, ISH, PCR technology as well as molecular/biochemical and multiplex bead assays.  Responsible for the analysis and interpretation of test results and for following all SOPs and safety guidelines while producing quality test results.  Applies basic laboratory techniques and skills to conduct pre-designed experiments, making detailed observations and analyzing data with a high level of accuracy.  Prepares technical summaries and protocols for internal use.

Essential Job Functions

Technical Operations
•   Analyzes raw, in-process materials and finalized products using IHC, ISH, ELISA and molecular/
biochemical techniques.
•   Analyzes and interprets test results according to established quality control guidelines.
•   Inspects in-process and final products.
•   Monitors various quality control and production equipment parameters to ensure proper calibration and operation.
•   Maintains laboratory instruments and facilities in good working condition.
•   Plans and performs short and long-term stability testing.
•   Executes and completes validation reports for processes and test equipment.
•   Notifies management of any and all issues that may affect product quality.
Research and Development
•   Develops and improves in situ hybridization (ISH) reagents (FISH and CISH probes).
•   Develops and improves immunohistochemistry (IHC) reagents (primary antibody, detection system, etc.)
•   Develops DNA/RNA probes, immunodetection reagents for chromogenic in situ hybridization.
•   Develops primary antibody, immunodetection reagents for immunohistochemistry and other immunoassay.
•   Performs bacterial culture, glycerol stock, DNA/RNA extraction, purification, restriction enzyme digestion, PCR, probe labeling, gel electrophoresis, and tissue culture.
•   Performs cell culture, antibody purification, and conjugations.
•   Performs blast search, genome browser, PCR printer design, DNA sequence alignment.
•   Conducts DNA/RNA probe testing and antibody testing during different development stages.
•   Communicates with other departments or vendors to coordinate work.
•   Reviews reference papers and selects tissues for specific antibody testing.
•   Drafts product technical report, production batch records, receiving record, MSDS and specification sheet.
•   Assists with product transfers.
•   Conducts experiments using laboratory equipment and calculations.  Plans the use of equipment, materials and own workload.
•   Makes detailed observations and analyzes data.  Maintains thorough records and training files.
•   Contributes ideas and suggestions to improve standard laboratory techniques, protocols, processes and equipment.

Quality/Business Systems Activities
•   Ensures that the Quality/Business System is understood and deployed.
•   Actively seeks opportunities to continuously improve.

•   Ensures applicable standards and systems implementation for ISO and FDA QSR’s are met.
•   Oversees preventive action based on improvement opportunities or trends identified during Leadership Review meetings.
•   Initiates action items and assigns responsibilities.

Requirements

Experience & Minimum Qualifications
•   3 – 5 years of related experience or equivalent combination of education and experience.
•   Previous GMP/GLP experience.
•   Ability to work independently and effectively troubleshoot.
•   Ability to adapt to constant changes and work effectively under pressure and time constraints.
•   Effective communication skills.  Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
•   Excellent mathematical skills.  Ability to apply advanced mathematical concepts such as exponents, logarithms, and quadratic equations.  
•   Knowledge of biochemical processes including:  Spectrophotometry, Bacterial Culture,
•   Chromatography, PCR, Probe and In situ hybridization, Antibody and Immunohistochemistry (IHC),
•   Mammalian cell culture, DNA and RNA, Cell Blocks.
•   Ability to effectively interact with diverse personalities.  Must be tactful and flexible.
•   Possesses excellent communication skills with department personnel, corporate management
   team, company affiliates and vendors.

Physical Requirements & Working Environment
•   Ability to lift 50 lbs with assistance.
•   Ability to work with human plasma-based products.
•   This position frequently works in a laboratory environment or clean room and requires wearing a full gown and dust masks.
•   Ability to read and analyze hard written copy and information on a computer screen.
•   Ability to successfully respond to multiple work pressures.
•   Ability to listen, resolve problems, and manage tasks.
•   Ability to effectively communicate verbally and in writing to individuals and groups.
•   Ability to meet multiple deadlines and work under time constraints.
•   Ability to effectively interact with diverse personalities.  Must be tactful and flexible.
•   Must be able to manage change effectively.
•   This position requires the employee to frequently sit.  In addition, the employee is occasionally
   required to stand, walk, use hands and fingers and reach with hands and arms.


Affirmative Action Employer
Equal Opportunity Employer