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Senior Manufacturing Associate I
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Senior Manufacturing Associate I : MedImmune, LLC.
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| Job Number |
01838 |
| Employee Type |
Full Time |
| Company Name |
MedImmune, LLC. |
| Location |
Gaithersburg
Maryland
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| Salary (year) |
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| Start Date |
2/9/2010 |
| Industry |
Biotech |
| Job Type |
Development-Manufacturing-Sciences |
| Relocation |
Not Required |
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| Description |
Description
Title: Senior Manufacturing Associate I
Location: MD, Gaithersburg - Corporate Headquarters
Req: 01838
Description of Position
Responsible for the adaptation of transferred information for Phase I through Phase III processes from Development (Cell culture and Purification) to Clinical Manufacturing. Involved in the creation of production documentation, evaluation of process fit to facility and schedule, analysis of production data, identifying trends and researching causes for variations in production processes. Works closely with other groups within MedImmune (Development, QC, QA, Engineering, Materials Management, Validation) and acts as facilitator to initiate change.
About the Organization
My company shares my
passion for helping to improve human health around the world."
"This is My MedImmune."
Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc.
Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities…that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world.
Company Information
MedImmune, LLC. is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.
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| Requirements |
Position Requirements
Principal Duties
Program development for chromatography controller, MF/UF skids, and Bioreactors.
Understands the operational principles of production equipment including bioreactors, centrifuges, filtration devices, and chromatography equipment. Is available for trouble shooting technical problems, providing suitable solutions, and can oversee and coordinate implementation of the corrective actions as necessary.
Monitors manufacturing data, develops spreadsheets and methods for trending data that may illuminate subtle issues in the manufacturing process.
Authors Master Production Records (MPR¡¦s), Standard Operating Procedures (SOP¡¦s) and Solution Preparation Records (SPR¡¦s) as needed to accurately reflect manufacturing processes as dictated by development.
Authors Master specifications for new raw materials.
Creates Bill of Materials (BOMs). Works closely with Materials Management to ensure that materials are available for production.
Coordinates the startup and validation efforts for new production equipment and may represent manufacturing sciences during Factory Acceptance Testing of new equipment.
Works on assignments that are complex in nature where independent action and a high degree of initiative are required in resolving problems and making recommendations.
Provides training and guidance to junior staff.
Frequently interacts with subordinates, and other production sub-groups, and functional peer groups at various management levels. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects/ schedules, etc.
Evaluates operating procedures for accuracy and efficient operation and makes improvements and optimizations to manufacturing methods.
Has good interpersonal skills, is attentive and approachable. Discusses problems with colleagues and senior personnel.
Maintains a professional and productive relationship with supervisor and co-workers.
Educational Requirements
Qualifications
Requires a Bachelors/ degree in a scientific discipline with a minimum of 5 to 7 years related experience or 3 to 5 years with a Masters degree with demonstrated working knowledge of scientific and production related principles. GMP experience a must.
MedImmune does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on MedImmune’s approved agency list. Unsolicited resumes or candidate information submitted to MedImmune by search/recruiting agencies not already on MedImmune’s approved agency list shall become the property of MedImmune and if the candidate is subsequently hired by MedImmune, MedImmune shall not owe any fee to the submitting agency.
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