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Associate Director Process Engineering Development Job at Engineering & Maintenance at Sanofi

Location Framingham, Massachusetts Job Category Engineering & Maintenance Requisition Number POS_75110503-1
Associate Director Process Engineering Development-POS_75110503-1


Description
Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.

Genzyme Corporation (a Sanofi company) and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.


DEPARTMENT DESCRIPTION:

Manufacturing Science and Technology (MSAT) 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 MSAT Laboratory group is responsible for providing laboratory based technical support to Framingham Biologics manufacturing facilities. The primary objective is to ensure manufacturing processes are capable, compliant, in control and continuously improved. MSAT 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.
Designing and executing experiments to expand design space knowledge for commercial manufacturing processes.
Enabling effective technology transfer efforts.

POSITION OVERVIEW / KEY RESPONSIBILITIES*:

The Associate Director of Manufacturing Science and Technology (MSAT) reports to the Head of MSAT for Framingham Biologics and is responsible for providing leadership and technical management of an MSAT team supporting protein purification, formulation, and buffer preparation. The role will have responsibility for both operational support and laboratory support groups.

The Associate Director will lead a team of managers, engineers and scientists whose primary responsibilities include providing technical support to Manufacturing and Quality by serving as the process and technical experts for the site. They provide expert support to plant floor operations, lead investigation teams in solving complex manufacturing investigations, support technology transfer teams, identify opportunities to improve systems and practices, and provide input to product/process development teams. The group is also responsible for analyzing and interpreting data from manufacturing operations and laboratory experimental data.

The Manufacturing Science and Technology group will also recommend process and operational changes to overcome process issues, avoid deviations, and improve productivity; conduct thorough investigations and data analysis to identify root causes for deviations and investigations, implement corrective and preventative actions and change controls; and prepare and/or manage the preparation of technical reports in support of process improvements and technology transfer.

Major responsibilities include:

Manage a department of managers, engineers and scientists that provide scientific/technical support, expertise and guidance to Manufacturing and Quality in the areas of protein purification, formulation, buffer preparation, analytical support, statistical analysis and data trending for one or more commercial products.
Drive programs that will enable MSAT to maintain the processes and operations in a validated state of control.
Provide input to and coordinate support from process development teams.
Provide representation on Corporate and Operations project teams. Assure that project activities and 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, Science, Manufacturing, and Quality Departments, to coordinate project 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.
Develop, maintain, and adhere to the MSAT Laboratory budgets.

* Key Responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs


Qualifications
BASIC QUALIFICATIONS:

• Degree in life sciences, engineering or other relevant degree

• BS with 14+ years OR MS with 10+ years OR PhD with 8+ years of experience

• At least 5 years of experience in biologics development, bioprocess engineering and/or commercial manufacturing operations

• Minimum of 2+ years’ experience in direct management of technical staff up to PhD level


DESIRED QUALIFICATIONS:


Demonstrated commitment to continuous improvement – at the individual, department and organizational levels.
Experience in technology transfer
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 with change management.
Experience managing technical teams
In-depth understanding of large scale biotechnology unit operations, principles of SIP and CIP, principles of biochemical engineering, and process data analysis.
Experience in the dynamic management and leadership of technical teams
Knowledge of CGMP requirements and ICH guidelines in a regulated environment.
Strong technical writing skills


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:

Respecting the laws and operating within the applicable 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.

• Strives for results – sets ambitious tangible and measurable targets ; takes personal responsibility for achieving results; reviews and evaluates progress against agreed targets, timelines and budgets

• Cooperates transversally – Shares information and seeks input from outside direct team. Develops strong cross functional relationships and partnerships with science and commercial organization

• Commit to customers- Shares relevant information openly and seeks appropriate input from others outside of the direct team; develops and maintains effective cross-functional working relationships and partnerships; responds positively and constructively to requests for support from across the organization



• Act for Change – Creatively challenges the status quo to find new ways of working; looks for the opportunities that arise during times of change; readily adapts to new environment, jobs, technologies and processes, continuously looking internally and externally for best practices and areas for improvement. #LI-GZ


Job : Engineering & Maintenance
Primary Location : United States-Massachusetts-Framingham


Job Posting : Mar 22, 2017, 3:19:05 PM

Job Type : Regular
Employee Status : Regular