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Manufacturing Specialist-23269  

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.

The Manufacturing Specialist uses expert knowledge of compliance and cGMP manufacturing processes to manage and own all process related documents, to include: investigations, training and improvement initiatives within upstream operations.

As a document owner manages the Document Change Request (DCR) process for all process related SOPs and Production Records along with Temporary Change Requests (TCRs) ensuring accuracy and consistency. Authors complex explicit documentation for new procedures as well as for current procedures. Also be responsible for ensuring training of staff members on process related DCRs or TCRs.

As an investigator, the Manufacturing specialist will utilize their strong understanding of compliance and cGMP to mange cross functional teams to drive investigation close out, determination of root cause and implementation of appropriate Corrective and Preventative actions. Creates and presents trending and metrics reports on deviations and corrective actions.

Owns the management of the Manufacturing training curricula and works with Manufacturing Supervisors and the Quality Training group to develop and ensure consistency in training materials through the On-the-job training program on process operations, theory and compliance. Occasionally may include performing training with staff on the floor and performing a Train-the-Trainer role.

Works independently with minimal supervision and direction. Participates in determining objectives of assignment. Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion. Duties require advanced knowledge in specialized field of learning.

Basic Requirements:
An advanced level of technical background in therapeutic biologics manufacturing is required, typically represented by a Bachelor's degree and 5 - 8 years of prior experience in cGMP Manufacturing Operations with proven project management, industry process knowledge, skills management, communication, and troubleshooting skills.

Job: Manufacturing & Development
Primary Location: United States-Massachusetts-Framingham
Shift: Day Job
Job Type: Regular
Employee Status: Regular
LocationUnited States-Massachusetts-Framingham
CountryUnited States of America
Web Link
Posted Date05/26/2011 01:04:47
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