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.
Manager, Manufacturing Technical SupportManufacturing 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 strategy for process validation activities
- 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 Manager of Manufacturing Technical Support (MTS), reports to the Associate Director of the Framingham MTS lab, and is responsible for providing leadership and technical management of an MTS lab team.
- The Manager will lead a team of engineers/scientists whose primary responsibilities include executing cell culture and/or purification experiments in support of commercial GMP operations at Genzyme's Framingham Manufacturing Sites.
- This includes, but is not limited to, experimental support for deviations or manufacturing investigations, process troubleshooting, raw material evaluation, support of validation programs, exploration of process design space and continuous process improvement - The team is also responsible for analyzing and drawing accurate conclusions and recommendations from the experimental data.
Major responsibilities of the Manager position will include:
- Manage a group of engineers/scientists that execute cell culture and/or purification experiments and analyze/document data and learnings in technical reports and presentations.
- Serve as technical leader for operations within the group.
- Provide input to and coordinate support from process development teams as needed
- Keep abreast of new developments/technologies in areas of responsibility.
- Support ongoing development of staff to maximize individual and team performance. Serve as coach/mentor to staff.
- Interact with colleagues from the site MTS teams and other functions.
- Support documentation preparation for regulatory purposes and stay current on regulatory requirements that have impact on manufacturing processes and evaluate/implement changes if required.
- Provide CMC support and guidance for product life cycle management.
- Attend development and scientific meetings to remain current with technology and regulatory guidelines.
- Initially, this position will be responsible for activities related to start up and operational readiness of the Framingham MTS lab.
During the construction and start up phases, this individual will assume the role of System Owner for specific systems/equipment (e.g. bioreactor, purification skids) and work in close collaboration with the Engineering project team . Responsibilities will include leading a small team in the following: developing User Requirements for process equipment, evaluating vendor and design options, designing and executing Wet Test, Qualification and sterility studies, setting up Automation and Data systems and 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 team of 3-4 Process Engineers or 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 participate in setting 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.
- Bachelor's degree in Life Sciences, Chemical Engineering or Pharmaceutical Sciences or a related field
- 10 years of experience in biotechnology processes inclduing: process development or manufacturing technical support with experience in process development, specifically cell culture and/or purification and managing technical teams.
- Masters degree
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