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.

Quality Control Microbiology Department supports manufacturing activities at Genzyme Allston Landing by detecting, quantifying and identifying possible contaminants that may interfere with the quality of the product during the different stages of the manufacturing process. It aims to maintain a state of microbiological control in the Utility Systems and within the environment where the manufacturing process is executed. It assesses the aseptic behavior of the personnel involved in these processes; and contributes to the guarantee that the end product will meet the pre-defined standards for safety, purity, identity and effectiveness.

The schedule for this position is Friday-Monday from noon-10:30pm.This individual will report to the QC Unit Manager in the Allston Quality Control laboratory. This motivated and organized individual with strong people skills will provide supervision and technical expertise to the QC Microbiology lab while maintaining open communication channels to meet the needs of the organization. Provides day to day direction to staff. Supports manufacturing activities.

Major Responsibilities and testing may include but are not limited to:

Personnel Management
- Lead the QC Micro team while embodying the principles of the Genzyme Global Leadership model
- Interview and hire potential candidates to fulfill business needs
- Motivates and retain talented individuals within the QC Microbiology Department
- Manage and develop 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

Training/Compliance
- Ensure execution of QC microbiology laboratory activities in strict accordance with Standard Operation Procedures, GMP and Regulatory requirements
- Schedule and/or delivers training to QC Microbiology personnel in accordance with Department Training Plan to ensure staff can perform assigned tasks correctly, safely and compliantly

Production
- Assign tasks, create and update direct reports schedule
- Supervise operations in the QC Microbiology Lab during the applicable shift
- Represent the functional area in meetings and compliance activities
- Analyze Environmental Monitoring and Utility Systems data and write trending reports
- Review and audit documentation to ensure accuracy, specifications and GMP compliance
- Coordinate and support validation, engineering and production assignment according to manufacturing schedule without compromising quality
- Oversees sampling and laboratory testing execution to produce results in timely manner without compromising quality
- Review SOPs, coordinate method development and ensures concurrency with cGMP regulations and requirements
- Maintain positive relationship and network effectively across sites and organizations

Continuous improvement
- Utilize process and technical knowledge and investigation skill to identify and rectify departmental issues
- Contribute to the improvement of all QC Micro

Safety
- Ensure Personnel Protective Equipment is used in the laboratory area
- Ensure proper handling and disposal of chemical and reagents
- Encourage safety behavior within the laboratory area

Deviation Management
- Responsible for the documentation and investigation of laboratory deviations, errors, and out of specifications/out of tolerance results
- Participate in the investigation of Alert/Action, excursions and atypical results

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.

Basic Qualifications:
- Bachelor's Degree in Life Sciences discipline and 6 years experience in CGMP lab environment

Or

- Master's Degree in Life Sciences discipline and 4 year experience in CGMP lab Environment
- Proficient in MS Office And lab based data management systems
- Scientific technical writing ability
- Ability to present technical data
- Ability to coordinate scientific projects
- Experience in a lead or Supervisory, specifically training, coaching and mentoring junior level employees
- Ability to gown and gain entry to manufacturing areas
- Organizational Skills
- Experience troubleshooting and investigating assay and equipment issues
- Experience with identifying root cause
- Familiarity with USP and global compendial regulations
- Ability to gown and gain entry to manufacturing areas

To apply for this position, please CLICK HERE