Description

Genzyme Corporation, ranked as one of the foremost biotechnology companies in the world, is committed to providing an exceptional environment in which individuals can excel, and achieve their professional and personal goals. Genzyme’s people and culture have been consistently recognized for excellence. For example, we have been named several times to Fortune’s list of the 100 Best Companies to Work For in the United States. We also consistently rank among the top employers for scientists in surveys of Science readers. Genzyme’s local offices and facilities in Europe and other parts of the world have earned similar distinction as respected employers. By applying for a position with Genzyme, you are taking the first step toward becoming a part of our dynamic and talented team, and sharing in our continued success.

We currently have an opportunity for the right candidate to join our Gene Therapy Operations team based in San Diego, California. Genzyme’s Gene Therapy Operations is an multi-disciplinary, state of the art manufacturing operation supporting the development, manufacturing and testing of novel Gene Therapy-based products for the treatment of genetic and acquired diseases

Senior Manufacturing Associate

Job Responsibilities:

Performs process operations, including tissue culture, purification, preparation of bulk
solutions, aseptic fills and labeling of vials under sterile and non-sterile conditions,
routine buffer and media preparation, filtration, vial preparation and sterilization.
Writes and reviews cGMP documentation including standard operating procedures,
master production records, material and product specifications related to cGMP
manufacturing of cell and viral-based products.
Operates manufacturing equipment in accordance with standardized procedures and
within safety guidelines.
Leads troubleshooting of manufacturing processing problems.
Implements production procedures to optimize manufacturing processes.
Creates schedules and work plans in accordance with project timelines.
Provides support for validation activities for cGMP operations including IQ/OQ/PQ and
process validation.
Identifies opportunities for improvement in cGMP manufacturing systems and
procedures.
Provides technical training to manufacturing staff in area of expertise.
Performs all operations with emphasis on safety
Works a flexible schedule to support process demands, including occasional weekends,
off-shifts, and overtime.
Supports cleaning of equipment and facilities as necessary to ensure compliance with
cGMP and regulatory requirements.

Qualifications

Basic Qualifications:

Minimum of AA degree in related discipline and 6-8 years of cell culture/purification development and/or cGMP experience is required.
Preferred Qualifications:
Demonstrated ability to work effectively in cross-functional teams.
Experience in classified clean room manufacturing operations.
Basic technical knowledge with respect to other aspects of biologics manufacturingCompetency in Microsoft Word, Excel and Outlook.

Job
: Manufacturing & Development
Primary Location
: United States-California-San Diego

Job Posting
: Mar 23, 2010

Shift
: Day Job
Job Type
: Regular
Employee Status
: Regular

https://genzyme.taleo.net/careersection/external/jobdetail.ftl?job=39940&src=JB-10223

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