Sanofi Group Tech Transfer Support Manager - Vaccine in Pearl River, New York
Summary of Major Responsibilities
Identify, investigate, gain consensus, and resolve issues and capitalize on improvement opportunities that impact the tech transfer of Flublok and Panblok Drug Substance downstream manufacturing process to Swiftwater, PA from Pearl River, NY (RAPID project). Work with and support Deputy Director of Pearl River and Swiftwater sites during the facility design, process transfer and operational processes design and implementation. Support project deemed important to the safety, quality, efficiency, and effectiveness of the manufacturing site.
Provide operational input regarding clarification, purification and filtration equipment and process changes, as well as ensuring required documentation, qualification, and validation. Serve as a scientific and technical interface with suppliers of equipment and materials. Provide basic engineering and/or scientific expertise within a cross functional team to support, troubleshoot and drive system/ operational improvements.
( + ) Safety
Ensure all Manufacturing operations are conducted in compliance with Health, Safety, Environment regulations. Responsible for engaging, investigating, and correcting departures from expectations to ensure the highest safety standards are maintained.
Q uality, Compliance, and Regulatory Inspections
Ensure all Manufacturing operations are conducted in compliance with cGMP’s, safety regulations. Responsible to do the following:
Serve as SME for those items related to deviations or CC, CAPA, Documents and Audits, as appropriate.
Ensures quality systems items are written in a compliant manner and serves as reviewer/approver of those items as required.
Participates in the training process for new team members/processes
Helps others work through issues and remove roadblocks regarding quality systems actions assigned to their team
Helps manage the workload to meet the team’s priorities
D elivery, Supply, Operational Performance
Responsible for the associated Manufacturing function to ensure sufficient bulk product is released at the appropriate time and quality level to meet requirements for domestic, foreign, and contracted vaccine sales.
Ensure the requirements for successful Flublok DS production are adequately represented and taking in consideration during the facility design, process transfer and operational processes design and implementation. Represents DS Manufacturing as SME on the overall RAPID project activities.
C ost / Financial Performance
Participate and support cost reduction initiatives, as assigned.
I nvolvement / People
Aide in the development of a highly trained organization that can respond to a wide variety of demands while respecting the company values and culture. Ensure representation at Level 1 and/or Level 2 +QDCI boards and understand their connection to the Protein Sciences Level 3 boards. Help to create a continuous improvement culture by supporting and leading projects for process improvements.
Context of the job/major challenges
Strong leadership skills required to lead in a safety and quality focused manufacturing environment. Strong cross-functional working skills to cut across boundaries within and outside Protein Sciences Manufacturing.
The scope of this role is Manufacturing within the Protein Sciences manufacturing sites. This role is responsible for completing quality systems items that impact the timeliness and supply of compliant drug substance to US and international markets.
- Geographical scope includes Swiftwater, PA and Pearl River, NY (travel to Swiftwater may start at 30% of time during facility construction, peak to 80-100% during process transfer)
Serving as a leader in the associated functional group in Manufacturing to meet a demanding supply schedule while exceeding standards requires a high degree of flexibility and commitment. Supervision of associated quality systems operations within one level of management is required. Decisions are made on complex matters involving short term commitment of resources.
Freedom to act, level of autonomy
This position should be able to independently support, intermittently and in the short term, all activities in the Protein Sciences Manufacturing areas. Under minimal guidance, provides analysis and recommendations to management on all compliance systems related matters. Decisions must be made in a dynamic setting considering and balancing a changing business environment, business priorities, product and process deadlines and compliance issues. Must address internal and external regulatory requirements.
Bachelor’s degree required with 5 years' experience in cGMP vaccines / pharma manufacturing industry.
Knowledge of industrial techniques, cGMP and working in a regulatory environment
Excellent organizational, interpersonal and teamwork abilities are required.
Experience in multicultural complex environment
Experience in project management
Excellent verbal and written communication
A strong customer focus and ability to prioritize and adapt to business needs are required.
Bachelor’s degree (science, engineering preferred)
Proficient in MS Word, Excel, PowerPoint. Phenix, GEODE+ preferred
Knowledge of cGMP’s and regulatory requirements preferred.
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.