Manager Process Monitoring, Continuous Improvement - Vaccine

Job Title: Manager Process Monitoring, Continuous Improvement - Vaccine

Location: Swiftwater, PA

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as a Manager Process Monitoring, Continuous Improvement – Vaccine will have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

This position is designated for a Manager in the Formulation, Filling, Inspection, and Packaging (FFIP) Process Monitoring area. As a Manager Process Monitoring, you will be responsible for; but not limited to the following:

• Perform all aspects of Process Monitoring for products and processes within the FFIP platform.

• Perform trend analysis for critical quality attributes, critical process parameters and in-process data.

• Perform trend analysis for monitoring routine interventions for Sterility Assurance.

• Identify, perform and document investigation, root cause analysis, product impact analysis and corrective and preventative actions for out of trend (OOT) data

• Lead cross functional team meetings to review process monitoring data, trend evaluations and investigations

• Lead in the annual evaluation, analysis and implementation of changes to approved process monitoring criteria including report and procedure authoring and change control management

• Communicate product improvements/quality risks resulting from trend investigations to management and the shop floor

• Continually monitor and improve the Process Control Strategy (PCS)

• Collaborate with Data Science for PCS database updates and modifications including maintaining data bases and JMP scripts for trending and data analysis.

• Author applicable drug product sections in the Annual Product Reviews (APRs).

• Authoring Technical Summary Reports (TSR), such as, Praluent glide force, Time Out of Refrigerator (TOR) and Retention and Visual Inspection.

• Collaborate with FFIP and Data Science to maintain and update Shop Floor Data. 

• Participate in Initial Process Verification Plan (IPVP) and transition new products into routine process monitoring through change control management and procedure authoring.

Key Accountabilities:

• Perform trend analysis for critical quality attributes, critical process parameters and in-process data.

• Identify, perform and document investigation, root cause analysis, product impact analysis and corrective and preventative actions for out of trend (OOT) data.

• Lead cross functional team meetings to review process monitoring data, trend evaluations and investigations.

• Author applicable drug product sections in the Annual Product Reviews (APRs).

• Communicate product improvements/quality risks resulting from trend investigations to management and the shop floor.

• Lead in the annual evaluation, analysis and implementation of changes to approved process monitoring criteria including report and procedure authoring and change control management.

About you

Basic Qualifications:

• BS or MS required.  5+ years biological or pharmaceutical manufacturing, maintenance, engineering or analytical experience. 

• The individual should have worked with Operations personnel for at least 3 years and have a good understanding of current GMP/GLP, Continuous Improvement methodologies. The individual should have experience in regulatory inspections.

• Must have excellent written and verbal communication skills, as well as the ability to actively, and cooperatively work with cross functional teams.

• Experience using analytical tools such as SAS JMP and Excel are preferred.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

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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