Manufacturing Specialist - Investigations Team - Cell Culture Operations

One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since its founding in 1981, the company has introduced breakthrough treatments that have provided new hope for patients. The company's areas of focus are rare genetic diseases, multiple sclerosis, cardiovascular disease, and endocrinology. Genzyme is a Sanofi company. Genzyme's press releases and other company information are available at www.genzyme.com.

Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer healthcare, emerging markets and animal health. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

This Manufacturing Specialist position will support a newly built Perfusion Bioreactor Cell Culture Manufacturing Facility at 74 New York Ave. in Framingham, MA. The position will be part of a Cell Culture Operations Team which includes Equipment Preparation, Seed Culture, Media Preparation, and the Bioreactor Suite.

Uses advanced knowledge of compliance and cGMP manufacturing processes to manage deviation investigations, Corrective and Preventative Actions (CAPA's), change requests, training and improvement initiatives within Cell Culture Operations.As an lead investigator, the Manufacturing Specialist will utilize their strong understanding of compliance and cGMP's to manage cross functional teams to drive investigation close out, determination of root cause and implementation of appropriate CAPA's. Creates and presents trending and metrics reports on deviations and corrective actions.

Lead Management of the electronic Document Change Request (eDCR) process for all process related SOPs and Electronic Batch Records (EBR's) ensuring accuracy and consistency. Author complex explicit documentation for new procedures as well as for current procedures. Performance of end user testing on EBR changes prior to release to the manufacturing floor. Also be responsible for assisting with the training of staff members on process related change requests.Responsible for the management of the Manufacturing training curricula modules. The position will work 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.
As a continuous improvement driver helps with the implementation of projects and new business processes and systems. Examples include process improvements, Manufacturing Execution System (MES), lean transformation, and COGM reduction initiatives. May also be involved in scheduling client and production activities and should be very well acquainted with Delta V and MES.This is a Monday - Friday, 1st Shift Position

Basic Qualifications - 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.