Senior Manufacturing Manager
**Monday-Friday- 1st shift position*
**People management experience**
8 NYA is an integrated, continuous, biomanufacturing facility (ICBF). The facility is operated by upstream, and downstream and support services groups which support a 24/7 large-scale therapeutic protein manufacturing facility housing multiple products.
POSITION OVERVIEW WITH KEY RESPONSIBILITIES:
This Senior Manager position is in a large-scale cGMP biologics facility. Initial job responsibilities will include leading a team responsible for a diverse range of manufacturing-related activities during plant start-up from Operational Commissioning/Shakedown through process validation (PV) and commercial operations. The Senior Manager will be responsible for performing a variety of complex tasks under the general guidance and in accordance with the manufacturing instruction set and current GMPs.
Responsible for managing a cGMP biopharmaceutical manufacturing department consisting of operators and supervisors
Ensures execution of production plan across multiple shifts and manages staff performance against operational goals.
Provides leadership and direction to manufacturing supervisors and support teams.
Manages and develops the performance of direct reports by setting clear SMART goals and objectives and providing timely performance feedback, recognizing, and rewarding achievements and maintaining accountability
Provides input and recommendations on how to accomplish objectives with schedule changes and/or business needs.
Ensures timely issue escalation to manufacturing leadership and cross-functional support teams
Demonstrates flexibility, responsiveness, and teamwork in response to changing schedules and needs of the business Continuous Improvement
Contributes to continual improvement of all manufacturing documentation (SOPs, EWI’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.
*Key Responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs.
Able to work with and lead cross-functional teams through complicated processes in a Quality system
Capable of effective and clear communication that enables teams to execute on key deliverables
Experience coaching teams through regulatory inspections.
Bachelor’s degree with greater than 8-10 years of cGMP experience with 2-5 years of supervisory experience leading direct report and teams
Strong understanding of cGMP manufacturing
Demonstrated ability to effectively coach and train employees.
Master’s degree with greater than 2-5 years of experience in bulk biologics GMP manufacturing and 2+ years of experience leading manufacturing teams.
Training, coaching, leadership experience.
Experienced in 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:
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.
According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.
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.