Purification Supervisor Night Shift Job Listing at Genzyme Corporation in Allston, MA

Biotechnology, Pharmaceutical

Purification Supervisor, Night Shift-30025

Description
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.

Manufacturing Supervisor, Protein Purification, Nights
Hours: 7.00PM to 7.00AM, rotating shift

Downstream Operations is responsible for Cerezyme protein purification operations at Genzyme's Allston Landing, a large-scale therapeutic protein manufacturing facility. Downstream Operations' main function is multi-stage large scale chromatography operations. In support of our main functions, our additional functions include, cleaning and sterilization of process equipment, preparation of bulk product for shipment and final formulation operations.

This position is responsible for:
Personnel Management
Leading a manufacturing team while embodying the principles of the Genzyme Global Leadership Model
Ensuring execution of manufacturing activities in strict accordance with production batch records, standard operating procedures and CGMP
Maintaining a safe working environment and reporting incidents/accidents to site leadership
Managing and developing the performance of direct reports by setting clear "SMART" goals, providing timely performance feedback, recognizing and rewarding high achievers, and holding reports accountable for underperformance
Hiring and developing new employees, conducting performance appraisals and career development assessments for all direct reports

Training / Compliance
Implementing and maintaining production schedules for the Downstream Operations department while providing working knowledge of a protein purification process
Ensuring Manufacturing personnel are trained to perform all assigned functions and tasks
Partnering with Manufacturing Managers and Quality to ensure manufacturing areas are inspection ready at all times
Ensuring Manufacturing personnel are compliant with annual safety and CGMP training
Adhering to applicable requirements of the consent decree

Production
Operating complex systems and equipment in strict accordance with production batch records, standard operating procedures, and CGMP
Utilizing documentation control systems to author, review, and improve documentation
Utilizing process knowledge and investigation skill sets to identify and resolve departmental issues
Escalating production floor issues related to procedures, materials, process, equipment, automation, utilities and/or information systems to Manufacturing Management and/or appropriate functional area(s)
Adhering to site scheduling processes
Understanding Inventory Control and ERP systems

Deviation/CAPA Management
Ensuring personnel identify and document events that deviate from procedure
Partnering with Quality Assurance to detail particular deviations and complete the intake process
Completing investigations, reports, and proposes CAPA for minor deviations. Ensures on-time closure of minor deviations
Supporting major and critical deviation investigations
Ensuring on-time closure of assigned CAPA

Continuous Improvement
Contributing to continuous improvements of all manufacturing documentation (SOPs, MBR's, OJTs) to ensure they are current, accurate, and clear. Reviewing and refining the current document periodic review process to ensure that all Manufacturing documents re accurate and revised as necessary.
Managing or supporting plant floor continuous improvement initiatives including but not limited to Change Controls (CCR's), MDI, 5S, and Kaizen events
Working collaboratively with inter-department and cross-functional teams to affect necessary changes in a timely and productive manner

Leading People
Genzyme's leaders motivate, inspire, build, and retain highly effective manufacturing teams while managing for high performance and developing others. They are versatile learners and courageous decision makers

Leading the Business
Genzyme's leaders are effective operating in an evolving, complex and dynamic environment, providing clear direction and instruction to direct reports, and continuously looking internally and externally for best practices and areas for improvement.

Delivering to Customers
Genzyme's leaders understand patient and customer needs and build relationships as required to meet manufacturing goals while continuously improving operations by setting high standards for the team so they may perform to a level of excellence.

Qualifications

Basic Qualifications:

5-7 years in CGMP manufacturing environment

At least 1 year in a lead or Supervisor role

1 year experience with deviation or investigation management systems

Preferred Qualifications:

Associates or Bachelor's Degree in Biology, Chemistry, Biochemistry, or Chemical Engineering

Extendsive experience in large-scale chromatography

Training, coaching, leadership experience

Experienced leading manufacturing teams to maintain adherence to a demanding production schedule

Experienced facilitating meetingsExperienced authoring and reviewing standard operating procedures, on-the-job-trainings, and other controlled documents

Familiarity with Deviation Management Systems (i.e. Trackwise).

Experienced in troubleshooting, investigation, and root cause analysis in a cGMP environment

Experienced in managing direct reports

Special Working Conditions:

Ability to lift up to 40 lbsAbility to stand for 6 hours in a production suiteAbility to gown and gain entry to manufacturing areas M*

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

Job Posting : Feb 14, 2013

Shift : Night Job / Third Shift
Job Type : Regular
Employee Status : Regular