Associate Director, Process Engineering and Development

Organization: 
Genzyme
Job Location: 
Framingham,MA
Job 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.

Job Title:Associate Director, Manufacturing Technical Support

Manufacturing Technical Support (MTS) is the keeper of the body of manufacturing process knowledge, supports the creation of the instruction set and ensures manufacturing operations stay aligned with the registered process.

MTS is responsible for:
- Providing daily on- the- floor technical support
- Providing technical leadership in process- related investigations
- Overseeing and leading data management & monitoring/SPC review processes
- Developing process validation strategy
- Maintaining the Process Control Strategy and Operating Control Strategy
- Identifying and implementing commercial process/product life cycle improvements
- Defining relevant operational/technical standards and practices for the site
- Identifying and driving implementation of improvements to maximize throughput and capacity utilization
- Utilizing and maintaining robust scale down models to support manufacturing operations
- The primary objective is to ensure manufacturing processes are capable, compliant, in control and continuously improved.
- The Associate Director of the Framingham Manufacturing Technical Services Laboratory reports to the Senior Director of Manufacturing Technical Services.
- This position will lead the Framingham MTS lab organization of 8- 10 Process Engineers and Scientists and be responsible for all Lab Operations.
- The scope of the Framingham MTS lab will include Cell Culture, Purification and Analytical support for commercial GMP operations at Genzyme's Framingham Manufacturing Sites.
- This includes, but is not limited to, support for deviations or manufacturing investigations, process troubleshooting, raw material evaluation, support of validation programs, exploration of process design space and continuous process improvement.
- Initially, this position will be responsible for the start up and operational readiness of the Framingham MTS lab.

During the construction and start up phases, this individual will assume the role of Area Owner for the MTS lab and work in close collaboration with the Engineering project team . Responsibilities will include driving the strategy and execution of lab start up including, but not limited to the following: developing User Requirements for process equipment, determining lab layout, evaluating vendor and design options, designing and executing Wet Test, Qualification and sterility studies, setting up Automation and Data systems and executing Technology Transfer of the small scale models and analytical methods into the MTS lab. Lab start up will culminate in Proof- of- Concept runs that demonstrate the ability to operate the qualified Scale down models in the Framingham MTS lab.

This individual will also be responsible for hiring and establishing a highly capable Lab Team of 8- 10 Process Engineers and Scientists, who will be responsible for executing start up activities and will then transition to designing and executing studies in support of commercial operations. This individual will also set up systems and governances for the functioning of the MTS lab including the following: Standard operating procedures, practices and policies, scheduling and logistics, training, documentation, data gathering and analysis and Service Level Agreements with customer groups. The lab will be operated under Good Laboratory Practices (GLPs), with engagement from the Quality Function as appropriate. This position will work closely with leaders from the MTS organization as well as Manufacturing and other site functions in order to ensure effective support for the Commercial processes.

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:
- Master's Degree in Life Sciences, Biochemical Engineering or Pharmaceutical Sciences or related fields and 10 years of experience in biotechnology processes in process development or commercial process support
- Hands- on experience in process development; specifically in mammalian cell culture, bioreactor/purification operations and analytical methods
- Experience with experimental design, with a sound understanding of process validation
- Experience in technology transfer
- Experience evaluating and implementing new technologies/techniques
- Experience with statistical tools for monitoring process performance and analysis
- Experience managing people and projects

Preferred Qualifications
- PhD in Life Sciences, Biochemical Engineering or Pharmaceutical Sciences, experience working in a CGMP, regulated environment
- Prior experience with large scale GMP process support
- Experience with facilitation
- Experience with change management
- Knowledge of biotechnology processes/concepts/techniques and engineering principles

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