Production Specialist - Vaccine

POSITION OVERVIEW

The Operations Systems Support Manager is a technical contributor to Flublok / Panblok manufacturing operations.

The role is responsible for supporting the technology transfer project from Protein Sciences Pearl River NY campus to Sanofi Pasteur’s Swiftwater, PA campus. Areas this role will support include engineering design, Commissioning & Qualification, startup of the cGMP manufacturing facility, and Product Dependent Performance Qualification for Flublok / Panblok drug substance in Swiftwater, PA. This role contributes to the overall project goals for safety, quality, compliance, productivity and performance of Vaccines Industrial Affairs. Responsibilities will include:

• preparation of user requirements specifications and supporting the purchase of equipment

• Supporting the project with system installation, setup and validation of equipment

• Representing Operations in engineering design phases of the project

• Writing and approval of standard operating procedures, batch records, logbooks

• Review and approval of system design specifications, C&Q and validation protocols and summary reports for process and equipment. Supporting the execution of these C&Q and validation protocols will also be required.

• Work collaboratively with engineering, validation, quality assurance, quality control and manufacturing technology groups as well as external stakeholders to accomplish business needs

• Support the implementation of the manufacturing execution system to optimize control of process management and production systems, equipment management, electronic documentation systems, and data historian

• Provide training, instruction, guidance and direct support of techniques or operations to operations staff

• Proactive anticipation and effective communication of successes, constraints, conflicts, solutions and actions for resolution

• This role will initially have no direct reports with potential for direct reports in the future.

As later phases of the project continue, the scope of this position will expand to include:

• support for hiring manufacturing staff and training personnel

• scheduling operations and personnel staffing

• personnel and process performance monitoring

• writing investigations, deviation reports and change controls

• implementation of corrective and preventive actions

• support for internal and external site audits and response to observations

• continuous process improvement projects

• support in housekeeping, facility cleaning daily manufacturing needs and the overall compliance within the manufacturing groups.

• This role has the responsibility of back-up Shop Floor Manager as needed and will support execution on the manufacturing floor when required

• Ensures all materials required for production are available prior to need.

• Ensures the completion of sampling and corresponding documentation as required.

• Ensures the completion of move tickets and pick lists in an accurate and timely manner to ensure accurate inventory.

• Participates or leads in all aspects of production process (SAP, cycle counting, LIMS, Process Control System, etc.).

• Role may develop to include direct reports

Basic Qualifications:

• Minimum Bachelor's degree in basic sciences (biology or biotechnology preferred) or scientific engineering, such as biomedical, chemical or bioengineering AND

• Minimum 4 years' experience in biotech / pharmaceutical industry within a manufacturing / production environment AND

• Familiarity with the Flublok production process, OR

• Experience with bioreactors, cell culture, centrifugation, column chromatography, tangential flow filtration, media and buffer prep is preferred.

Special Working Conditions:

• Position will be based in Swiftwater PA (80%) with travel as required to Pearl River NY (20%).

• Position is expected to transition fully to Swiftwater PA by Q3 2021.

• Schedule is primarily first shift, Mon-Fri 8am-5pm, plus flexibility outside these hours as necessary.

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.

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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.