**12-hour rotating day shift position including holidays and weekends**
**Downstream experience- Solution/Equipment prep experience**
The Downstream Operations Department performs multi-stage large scale chromatography, tangential flow filtration, final formulation, viral filtration, and cleaning of process equipment as part of a 24/7 large-scale therapeutic protein manufacturing facility.
POSITION OVERVIEW/KEY RESPONSIBILTIES:
This is a 1st shift position in a new large scale cGMP biologics facility which includes solution preparation, equipment preparation, upstream operations, and downstream operations. Initial job responsibilities will include leading a Downstream Operations team responsible for a diverse range of manufacturing related activities during plant start-up from Operational Commissioning/Shakedown through process validation (PV).
The primary job function post PV runs will be Downstream Operations. Responsibilities will also include supporting Upstream and Support Operations as necessary. The Manufacturing Supervisor will be responsible for managing a manufacturing team and leading the manufacturing floor operations including execution to procedures and schedule, personnel training, and containment/escalation of issues and deviations both within manufacturing and to support functions.
- Maintains a safe working environment and reporting incidents/accidents to site leadership.
- Assigns daily duties and tasks to all team members and ensures execution of manufacturing activities in strict accordance with production electronic batch records, standard operating procedures and cGMP.
- Manages and developing the performance of direct reports by setting clear “SMART” goals, providing timely performance feedback, recognizing and rewarding high achievers, and holding reports accountable for performance.
- Escalates production floor issues related to personnel, safety, procedures, materials, process, equipment, automation, utilities, and/or information systems to Manufacturing management and/or appropriate functional area(s).
- Provides working knowledge and technical leadership in chromatography, ultrafiltration/diafiltration, final formulation, viral filtration, and automation system (DeltaV).
- Cross train personnel from Upstream and Support Operations on Downstream Operations and provide employee feedback to management.
- Schedules and/or delivers training to manufacturing personnel in accordance with Department Training Plan to ensure staff can perform manufacturing operations correctly, safely and compliantly.
- Partners with Manufacturing Managers and Quality to ensure manufacturing areas are inspection ready at all times.
- Promotes “Right First Time” philosophy for all manufacturing activities.
- Operates complex systems and equipment in strict accordance with production batch records, standard operating procedures and cGMP.
- Performs batch record review.
- Supports and adheres to site scheduling processes.
- Demonstrates ability to troubleshoot basic mechanical and automation issues.
- Ensures manufacturing staff identify and document events that deviate from normal operation; supports deviation investigations.
- Partners with Quality Assurance to identify events that are deviations.
- Supports investigations, reports, and proposes CAPA for minor deviations.
- Supports Manufacturing Operations Manager and Manufacturing Specialist in the investigation, closure, and CAPA implementation for major and critical manufacturing owned deviations.
- Contributes to continual improvement of all manufacturing documentation (SOP’s MBR’s, OJT’s) to ensure they are current, accurate, and clear.
- Manages or supports plant floor continuous improvement initiatives.
- Represents Manufacturing in Project Team meetings; may lead department initiatives and projects.
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 Sanofi 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.
- Sanofi 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
- Sanofi 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
- Sanofi 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.
- High School diploma/GED with 6-10 years of experience in a cGXP environment, or a Bachelor’s degree with 4-8 years of experience.
- 1 year in a lead or supervisor role.
- Must have prior experience in cGMP manufacturing operations.
- Demonstrated ability to effectively coach and train employees.
- Ability to lift up to 50lbs
- Bachelor’s degree with 5-9 years of experience in bulk biologics GMP manufacturing and 2+ years of experience leading manufacturing teams.
- Extended experience in large-scale chromatography and ultrafiltration/diafiltration.
- Training, coaching, leadership experience.
- Experienced leading manufacturing teams to maintain adherence to a demanding production schedule.
- Experienced facilitating meetings.
- Experienced authoring and reviewing batch records, standard operating procedures, on-the-job-trainings, and other controlled documents.
- Experienced in troubleshooting, investigation, and root cause analysis in a cGMP environment.
- Experienced in managing direct reports.
SPECIAL WORKING CONDITIONS:
- Ability to lift up to 50 lbs.
- Ability to stand on average 10 hours per shift.
- Ability to gown and gain entry to manufacturing areas.
- Ability to work a twelve hour rotating shift and every other weekend, including some holidays.
Sanofi Inc. 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.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.