Sanofi Group Associate Director, Manufactuing in Ridgefield, New Jersey
Associate Director, Manufactuing
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.
Sanofi, an integrated global 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, consumer healthcare, emerging markets, animal health and the new Genzyme.
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, religion, sex, national origin, disability or protected veteran status, or any other characteristics protected by applicable law.
Manufacturing is responsible for bulk, fill and finish of prefilled syringe and vial products produced on the site. This includes hyaluronic acid (HA) extraction and purification, HA gel manufacturing, buffer production, formulation, filling, inspection and packaging. In support of our main functions, additional responsibilities include cleaning and sterilization of process equipment and aseptic cleaning. The Associate Director is responsible for a subset of the activities described above depending on current needs.
This position provides leadership and direction through managers or professional staff. Directs the development, planning, implementation and maintenance of manufacturing methods, processes and operations for new or existing products and/or technologies. Develops budgets for labor and capital expenditures for multiple cost centers and directs the allocation of significant resources to meet financial performance requirements.
Specific Responsibilities include:
Ensuring the safety of work practices in accordance with the Sanofi Safety Programs
Ensuring that all activities are in compliance with cGMPs
Ensuring that staff are sufficiently trained to perform their job responsibilities
Providing technical leadership for aseptic manufacturing.
Developing strategies that ensure achievement of objectives that are consistent with the site’s strategic direction
Managing employees, either directly or indirectly, who are involved in the scheduling, implementation, execution and/or maintenance of manufacturing processes and operations
Undertaking long and short-term planning and supervision of projects that require interaction with Manufacturing.
Overseeing, either directly or indirectly, Manufacturing investigations, process variances and deviations
Participating in the development, revision and accuracy of production plans.
Responsible for the Manufacturing annual budget and quarterly forecasting processes including work order variances and maintaining bill of materials and routings.
Focusing internally and externally; interacts internally with subordinates, peers, and senior management and interacts externally with regulators, customers, and suppliers.
Maintaining an external network of expertise and represents the division and company in professional organizations.
Specific Leadership Responsibilities include:
Providing effective leadership including: developing and implementing objectives and business strategies; selecting key personnel and motivating members of the functional area; challenging employees to develop as leaders while serving as a role model and mentor; assisting with performance calibration/talent pool management/succession planning; individual goal setting/performance reviews; training and development; supporting workforce diversity, quality and safety and supporting supervisors/managers in the management of their employees/department which support achievement of individual/department/business objectives
Establishing departmental and individual goals and objectives in alignment with site goals and priorities. Identifying performance improvement targets and metrics. Ensuring capabilities and capacity in place to effectively deliver on all departmental commitments and performance targets.
Strengthening overall leadership and organizational capabilities in area of responsibility. Building and sustaining high performance management team and ensuring strong alignment and coordination with other functional groups at the site.
Identifying the required resources and expertise, implementing the appropriate team/departmental structures and establishing the required processes and communications to enable department(s) to effectively deliver on all commitments while building a culture of Safety and Quality and continuous improvement.
Identifying and communicating risks in area of responsibility and across the site; creating strategies and plans to manage risk to the operations.
Participating in development of site long range in line with the corporate Long Range Planning.
Ensuring effective utilization of resources by ensuring robust employee development, performance management, succession planning, and rewards and recognitions practices in area of responsibility.
Managing headcount and expenses in area of responsibility to meet approved spending plan while achieving all departmental commitments and project objectives.
Motivating, retaining and developing key employees. Building and sustaining employee engagement by creating an environment within which individuals and teams can excel.
Interacting closely with BU, relevant sites and functions to define production plans, yearly goals and budgets for reporting functions/operations as well as long range plans (LRP and LRCP).
Our leaders motivate and inspire their people and build effective teams. They manage for high performance and develop others within the organization.
Our leaders are versatile learners who are comfortable with complexity and ambiguity. They are courageous decision makers who are candid and direct.
Leading the Business
Our leaders understand and respond to the evolving business environment. They think beyond their sphere of influence to see what is not obvious, and create a compelling vision and direction that inspires engagement from their people.
Our leaders continuously look internally and externally for best practices. They challenge the status quo and encourage their people to try new approaches. They have a track record of generating successful new ideas that improve business performance.
Delivering to Customers
Our leaders understand the patient and customer viewpoint. They build trust and collaboration by delivering exceptional service while balancing the needs of the individual with the greater good.
Our leaders set ambitious and realistic targets, drive for results, and build accountability within the organization. They set high standards and continuously improve.
- Bachelor's Degree in a science or technical field and 10 years of experience in biotech/pharmaceutical manufacturing or a related industry with 5 years in a manufacturing management position or an equivalent combination of education and experience.
Training, coaching, and leadership experience
Experienced leading manufacturing teams to maintain adherence to a demanding commercial production schedule
Experienced working with cross-functional teams, including Quality, Manufacturing Technical Support, Facilities and Engineering and Validation
Experienced authoring and reviewing standard operating procedures, on-the-job-trainings, and other controlled documents
Experienced with Deviation, CAPA, Change Control Systems (i.e. Trackwise).
Experienced in troubleshooting, investigation, root cause and risk analysis in a cGMP environment
Experience leading the implementation of improvements to technical and business processes
Experienced in establishment of safe practices in a cGMP environment
Project management skills
Expertise and knowledge in GMP engineering facilities and equipment design concepts in order to review engineering projects for compliance impact
Knowledgeable of requirements for post approval changes and of information typically found in the CMC sections of regulatory submissions.
Skilled in achieving results and managing others to achieve corporate, site, and departmental objectives. Excellent collaborator.
Excellent communication skills, good presentation and influencing skills and the ability to interact and gain the support of senior management
Process Development and/or Manufacturing Technical Support experience
Good knowledge of supply chain theory and practice.
Experience with SAP/Athena MRPII systems.
Primary Location: United States-New Jersey-Ridgefield
Job Posting: Aug 30, 2016, 1:50:37 PM
Job Type: Regular
Employee Status: Regular