Sanofi Group Vaccine Manufacturing Manager – Production (Influenza Bulk Drug Substance - Downstream) Vaccine in Swiftwater, Pennsylvania
SUMMARY OF PURPOSE/MAJOR RESPONSIBILITIES
Responsible for Manufacturing actives in assigned Downstream areas (1st Shift - 6:00 am - 2:30 pm).
Oversee Downstream production in accordance with volume fluctuation, business need, and effective procedures.
Collaborate cross functionally, to develop and implement changes, by participating in project teams to facilitate deviation reduction and continuous improvement.
Manage multiple priorities either independently or part of a team in order to meet key deadlines and communicate issues and progress across all levels of organization.
Support Deviation Closures
Resolve QA shop floor observations
Perform monthly HSE audits
Driving change; meeting company KPI’S managing +QDCI Boards
Establish performance expectations and evaluate with direct reports
Manage employee development short and long term goals - 10%
Coordinating Downstream Flu Operations.
Shift Change Attendance Labor Utilization Tool
Manage personal Ceridian/ Workday/ Involved with on boarding new hires
Monitor Metasys/ Labwatch tools for the production floor
Serve as an escalation point and make decisions to resolve issues
Responsible for project work on the shop floor providing assistance and or recommendations in regards to Upstream processes or equipment - 50%
Batch Record Section and Final Review/ Log book review. -10%
Provide training in accordance to deviations or procedural updates. - 10%
Perform manager review of Quality Documents. - 10%
Assist functional teams in identification of improvements to Safety, Quality, Delivery, Cost and Involvement and ensure alignment with site/function strategy. - 10%
CONTEXT OF THE JOB/MAJOR CHALLENGES
Is a trained manager to supervise downstream activities.
Ensure operational areas are running as intended to meet all operational goals.
Is accountable for the completion of downstream production and corresponding documentation, data entry, and delivery to internal customers.
Real time review of in process documentation.
Works to resolve all production issues. Understands next steps and works to guide others through the process to complete them.
Ensures downstream areas are staffed adequately.
Acts as a liaison for downstream technicians to dictate support.
Supervises downstream areas to ensure company goals are met.
Ensure preparedness for oncoming shifts.
Assists in completion of required BPR updates.
Works with Lead and senior technicians to ensure continuous operation.
Maintain an inspection ready area.
Bachelor degree, preferably in Life Sciences, Engineering or Management with a minimum of 5 years of experience OR six plus years' experience as a manufacturing technician at the Swiftwater Site that includes:
Working within a quality or production department of a pharmaceutical company
Experience managing direct reports
Experience in Viral manufacturing and/or Bacterial Manufacturing
Continuous improvement techniques and problem solving/analytical skills
OTHER SKILLS/ COMPETENCIES:
Excellent communication and interpersonal Skills
The ability to work on cross functional project teams
Demonstrated ability to meet/exceed timelines/deliverables
Ability to negotiate/Influence
Organized and detail oriented
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
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.