Sanofi Group Operations Support Manager - Vaccine in Swiftwater, Pennsylvania
The Operations Support Manager is a technical contributor to Flublok / Panblok manufacturing operations. The role is responsible for supporting the startup of the cGMP manufacturing facility for Flublok / Panblok drug substance in Swiftwater PA. This role contributes to the overall safety, quality, compliance, productivity and performance of the Sanofi Pasteur / Protein Sciences Manufacturing group.
During the engineering design and validation phases of this project, this role will primarily focus on technical writing to support the creation, review and approval of documents including standard operating procedures, standard work instructions, batch records and logbook forms.
As the engineering design and validation project phases end and manufacturing operations begin, this role will take on the coordination and management of the training system.
Additional responsibilities in both project and operations phases may include:
Implementation and support for Manufacturing Execution System (MES) to optimize control of process management and execution, systems and equipment management, electronic documentation systems and data historian.
Design, review and approval of single-use bags and components for upstream and downstream process functions
Installation and setup of equipment. Review, approval and execution support of protocols for process and equipment validation; review and approval of respective reports.
Work collaboratively with engineering, validation, quality assurance, quality control and manufacturing technology groups as well as external stakeholders to accomplish business needs
Proactive anticipation and effective communication of successes, constraints, conflicts, solutions, and actions for resolution
Performing deviation investigations; writing deviation reports and change controls
implementation of corrective and preventive actions
support for internal and external site audits and response to observations
process monitoring and continuous improvement projects
support in housekeeping, facility cleaning, daily manufacturing needs and the overall compliance within the manufacturing groups.
Provide training, instruction, guidance and direct support of techniques or operations to operations staff
This role has the responsibility of back-up Shop Floor Manager as needed and will support execution on the manufacturing floor as required
Experience in technical writing and MSOffice (Word, Excel, Powerpoint) is required.
Familiarity or experience with bioreactors, cell culture, centrifugation, column chromatography, tangential flow filtration, media and buffer prep is preferred.
Position will be based in Swiftwater PA. Schedule is primarily first shift, Mon-Fri 8am-5pm, plus flexibility outside these hours as necessary.
May include opportunity for minimal travel within first few months of role for training and process familiarization at manufacturing facility in Pearl River NY.
CONTEXT OF THE JOB/MAJOR CHALLENGES:
Candidate will be proactive and exhibit ownership of manufacturing systems.
Can focus to work on individual process improvement projects and also display leadership skills to train and lead operations in a quality focused manufacturing environment.
Strong cross-functional working skills to cut across boundaries within and outside Protein Sciences and Sanofi Pasteur Manufacturing.
Strong technical writing skills and proficiency in MSWord and MSExcel are required.
- BS/BA in basic sciences or engineering – preferably biology or biotechnology with a MIN of 3-7 years experience OR HS/GED with a minimum of 7 years' experience.
*Position will be based in Swiftwater PA. Schedule is primarily first shift, Mon-Fri 8am-5pm, plus flexibility outside these hours as necessary*
**Experience with technical writing, understanding and addressing deviation investigations and reports.
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.