Manufacturing Associate Sr Job Listing at Genzyme Corporation in Framingham, MA

Biotechnology, Pharmaceutical

Manufacturing Associate Sr-31019

Description
The Cell Culture Operations Department performs small and large scale cell culture operations, media preparation, equipment preparation, clean in place (CIP) and steam in place (SIP), and Preventative Maintenance of process equipment as part of a 24/7 large-scale therapeutic protein manufacturing facility.

Position Overview
This position is responsible for performing a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set and current GMPs.

Core Responsibilities
· Practices and promotes safe work habits and adheres to Genzyme's safety procedures and guidelines.
· Effectively demonstrates understanding of GMPs and how they apply to specific responsibilities.
· Follows verbal and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation.
· Identifies, escalates and documents events and subtle variances that deviate from normal operation; participate as needed in investigations.
· Maintains cleanliness and orderliness of process area.
· Ensures production area is stocked with supplies.
· Performs batch record review, procedure revisions, and work order generation.
· Fulfills role of lead trainer on numerous operations and is an area SME.
· Interacts with other support functions such as Quality Assurance, Quality Control, Manufacturing Engineering, MTS, Validation, etc.
· Utilizes manufacturing knowledge to improve process operations and affect positive change.
· Demonstrates ability to troubleshoot basic mechanical operations.
· Effectively utilizes Microsoft office applications.
· Mentors less experienced operators and performs support function for supervisor.
· Fulfills the role of Team Lead in the absence of the team supervisor. Responsible for assignment of duties to all team members, ensuring execution of duties, communicating at daily scheduling meetings, and providing technical support as needed.
· May be asked to represent the organization at meetings such as shift scheduling meeting, MDI, deviation review meetings, and project meetings.

Additional Responsibilities
· Small Scale Team
o Demonstrates general knowledge of mammalian tissue culture processes.
o Demonstrates general knowledge and practice of aseptic techniques.
o Provides daily monitoring of seed cultures including sampling and in process assays (cell counting).
o Cleans and builds equipment for manufacturing use including spinner flasks.
· Large Scale Team
o Demonstrates general knowledge of mammalian tissue culture processes.
o Completes tasks in support of large scale cell culture bioreactor operations.
o Provides daily monitoring of cultures and bioreactor processes including sampling and in process assays (cell counting).
o Demonstrates general knowledge of aseptic techniques.
o Performs PM, CIP, and SIP operations to prepare equipment for manufacturing operations.
· Equipment Preparation
o Demonstrates ability to follow detailed instruction set in order to execute production activities.
o Builds, cleans and sterilizes equipment to support Media/Buffer Preparation, Purification and Cell Culture equipment preparation.
o Demonstrates knowledge of Autoclave.
o Demonstrates knowledge of Clean out of Place (COP).
· Media Preparation
o Demonstrates general understanding of gas and liquid filtration.
o Demonstrates understanding PM, CIP, and SIP operations to prepare equipment for Media Preparation operations.
o Demonstrates understanding of application of sanitization practices.
o Practices ability to measure raw materials and operate basic Benchtop instruments.
Directs daily work activities and training of other staff.
An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

• Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.

· Being honest and treating people with respect and courtesy.
· Constantly striving to make Genzyme a great place to work, and a company respected for the quality of its people and products.
Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Qualifications
BASIC QUALIFICATIONS:

· High School Diploma/GED with 5-7 years in cGXP manufacturing environment, or Bachelor's degree with 3-5 years of experience.
Experience on-the-floor leadership or "subject matter expertise" in Cell Culture operations.

PREFERRED QUALIFICATIONS:

· Bachelor's degree with 4-6 years of experience in bulk biologics cGMP manufacturing.
· Effectively uses process automation systems to operate production processes (i.e. DeltaV).
· Training, coaching, and leadership experience.
· Experience reviewing and creating controlled documents.
Familiarity with deviation management systems (i.e. Trackwise). M*

Job : Manufacturing Development
Primary Location : United States-Massachusetts-Framingham

Job Posting : Sep 28, 2012

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