Director Process Engineering, Manufacturing Technical Support Job in Framingham, Massachusetts US

Director Process Engineering, Manufacturing Technical Support

Description

Description

One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since its founding in 1981, the company has introduced breakthrough treatments that have provided new hope for patients. The company's areas of focus are rare genetic diseases, multiple sclerosis, cardiovascular disease, and endocrinology. Genzyme is a Sanofi company. Genzyme's press releases and other company information are available at www.genzyme.com.
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer healthcare, emerging markets and animal health. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Director, Process Engineering, Manufacturing Technical Services
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
•Leading 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 Director of Manufacturing Technical Services reports to the Senior Director of MTS and is responsible for providing leadership and technical management of the MTS group supporting Cell Culture, Protein Purification Operations, Formulation, Buffer and Media Preparation. The primary responsibilities of the group include technical support to Manufacturing and Quality by serving as the process and technical experts for the site, supporting daily operations, leading investigation teams, participating in technology transfer teams, identifying opportunities to improve systems and practices, and providing input to product/process development teams. The group is also responsible for providing retrospective data analysis for process improvements, and providing input for complex manufacturing investigations.
The MTS group provides technical and scientific support to Manufacturing and Quality; recommends process and operation changes to overcome process issues, avoid deviations, and improve productivity; conducts thorough investigations and data analysis to identify root causes for deviations and investigations; implements corrective and preventative actions and change controls; and prepares and/or manages the preparation of technical reports in support of process improvements and technology transfer. MTS also provides input to and coordinates support from process development teams as needed and is involved in the design, implementation and analysis of laboratory, pilot plant and/or commercial scale work aimed at solving complex manufacturing problems; and represents the Manufacturing area on CMC teams and sub-teams.
Major responsibilities will include:

•Provide overall scientific/technical support, expertise and guidance to Manufacturing and Quality in the areas of Protein Purification Operations, Formulation, Buffer and Media Preparation, Analytical Support, Statistical Analysis and Data Trending..
•Lead a group of Process Engineers that will provide expert Manufacturing Technical Support to Upstream and Downstream Commercial Operations for the production of 2 commercial products
•Build an outstanding technical organization known for its expert and effective technical support
•Drive programs that will enable MTS to maintain the processes and operations in a validated state of control
•Be a respected and relevant part of the site leadership team; drive vision and improvements across functional areas to establish us as the "most value added producer of biologics" at Genzyme
•Provide input to and coordinate support from process development teams
•Provide representation on Corporate and Operations project teams. Assure that project activities/commitments are fully supported.
•Enhance the department with new competencies, technical and leadership depth. Support ongoing development of staff to maximize individual and team performance. Serve as coach/mentor to staff.
•Interact with colleagues from various Genzyme functions, in particular Engineering Technology Development, Science, Technical Support, Manufacturing and Quality Departments throughout the Genzyme Biologics Operations network to coordinate projects progression.
•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.
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

•Master's Degree in Life Sciences, Biochemical Engineering or Pharmaceutical Sciences or related fields and 10 years of experience in biotechnology processes at manufacturing scale
•Experience in technology transfer
•Knowledge of biotechnology processes/concepts/techniques and engineering principles
•Experience evaluating and implementing new technologies/techniques
•Experience with statistical tools for monitoring process performance and analysis
•Experience with experimental design, with a sound understanding of process validation
•Experience working in a CGMP, regulated environment
•Detailed knowledge of ICH guidelines
•Experience managing people and projects
•Experience with change management
•Experience with facilitation
Preferred QualificationsPhD in Life Sciences, Biochemical Engineering or Pharmaceutical Sciences or related fields