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 Technical Service (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. The Manufacturing Science Laboratory group within MTS is responsible for providing laboratory based technical support to both Framingham manufacturing facilities. The primary objective is to ensure manufacturing processes are capable, compliant, in control and continuously improved.
The Manufacturing Sciences Laboratory is responsible for:
- Providing technical leadership in process-related investigations- Developing strategy for process validation activities
- Provide input to the Process Control Strategy and Operational 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
- Lead the proposal, initiation, testing and implementation of minor proposed changes to purification processes.
- Develop, transfer and maintain robust scale down models to support manufacturing operations
- Design and execute experiments using scale down models and laboratory capabilities to support effective root cause investigations for commercial manufacturing operations.
- Design and execute experiments using scale down models to expand design space knowledge for commercial manufacturing processes.
- Utilize this knowledge to effectively support root cause analysis, process validation, implementation of process improvements, and improvements in process control strategies.
- Utilize scale down models and laboratory capabilities to enable effective tech-transfer efforts
Position SummaryThe Process Engineer II works in the Manufacturing Science group to provide expert technical support to Commercial Operations at the Framingham Biologics site. Responsible for executing 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. This person is also responsible for analyzing and drawing accurate conclusions and recommendations from the experimental data.
Core Responsibilities
This individual will work within the Manufacturing Science organization with the following responsibilities:
- Primarily responsible for hands on execution of experimental work in the Manufacturing Sciences laboratory.
- Interact with colleagues from the site MTS teams and other functions
- Provide technical support to GMP operations in a multi-product cell culture and purification plant.
- Partner with Manufacturing and Quality organizations in daily operations to maintain the process in a reliable state of control.
- Develop process knowledge and ownership.
- Perform process monitoring using a variety of data analysis methods and techniques (e.g., excel, JMP, etc.).
- Provide technical support and analysis for the resolution of deviations, investigations and process issues.
- Identify, own and resolve process issues proactively.
- Lead the proposal, initiation, testing and implementation of minor proposed changes to cell culture processes
- Completes technical investigations and provides technical expertise.
- Generate documents (technical memos and reports, protocols, etc.,) related to process monitoring programs and non-conformances.
- Participate in cross functional initiatives.
- Keep abreast of new developments/technologies in areas of responsibility.
Initially, this position will be responsible for activities related to start-up and operational readiness of the Framingham Manufacturing Science lab. Responsibilities will include: 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 Manufacturing Science 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 Manufacturing Science lab.
Qualifications
Leadership Qualifications
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.
Basic Qualifications
- BS in engineering with at least 3+ years, or MS in engineering with at least 1+ years relevant experience in a cGMP manufacturing environment.
- Hands-on laboratory experience in biotechnology protein purification processes.
- Knowledge of large scale biotechnology unit operations, principles of SIP and CIP, principles of biochemical engineering, and process data analysis.
- Understanding of compliance and cGMP considerations.
- Demonstrated commitment to continuous improvement - at the individual, department and organizational levels.
- Experience with high level data analysis and strong technical writing skills
Preferred Qualifications:
- Experience in the scale up and operation of large scale biotechnology processes.
- Hands-on experience with large scale biotechnology unit operations.
- Process development experience is highly desirable.
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