Associate Scientist, Production - Genemed - South San Francisco, CA | Biospace
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Associate Scientist, Production - Genemed

Genemed

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Location:
South San Francisco, CA
Posted Date:
2/9/2017
Position Type:
Full time
Job Code:
Salary:
D.O.E.
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

General Position Summary

Responsible for production activities including bulk formulations, filling and packaging final goods, as well as preparing and reviewing batch production records.  These products include IHC, ISH, molecular and immunochemical materials.  


Essential Job Functions

Technical Operations
•   Performs cell culture, antibody purification and conjugation.
•   Performs dilutions and calculations for bulk product formulations.
•   Cleans lab area and biosafety cabinets. Maintains production equipment and facilities in clean working condition.
•   Assists with transfer of new products into production after product approval during R&D.
•   Maintains raw materials and intermediate inventories.  Create Purchase Requisition when material is low in inventory.
•   Completes and reviews production batch records and validation documents.
•   Monitors various production equipment parameters and performs preventive maintenance to ensure proper operation.
•   Creates SOPs and other records for new processes and equipment. Updates procedures and records when necessary.
•   Notifies Production Lead of any and all issues that may affect product quality.
•   Drafts production batch record, receiving record, MSDS and specification sheet.
•   Conducts detailed observations and analyzes data.  Maintains complete and thorough lab notebook and training file.
•   Communicates with Order Management team to process order.
•   Advises supervisor of factors that may affect quality, accuracy and usefulness of data.
•   Assists other departments and performs other duties as assigned.

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.

Requirements

Education
•   BS or BA degree in Biological Sciences, Biochemistry or equivalent combination of education and experience.

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 and regulatory agencies.
•   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.
•   This position frequently works in a laboratory environment.
•   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