Offers “Sanofi”

44 days agoSanofi

Deputy Director, Process Validation Subject Matter Expert-Swiftwater, PA - Vaccine

  • Swiftwater, USA
  • Design / Civil engineering / Industrial engineering

Job description

Position Title

Deputy Director, Process Validation Subject Matter Expert

Location

Swiftwater, PA

WHO WE ARE

Sanofi is the vaccines division of Sanofi. We believe in a world in which no one suffers or dies from a vaccine-preventable disease. The Swiftwater site is located in northeast Pennsylvania and is home to the production of over 140 million doses of vaccine each year.

The Manufacturing Technology (MTech) drives the vaccines industrialization and the improvement of processes and products. It embarks on new technologies and digital trends and is the keeper of manufacturing process knowledge. MTech is at the crossroads of R&D and production as the team is spread over 9 production sites.

Close collaboration with R&D to ensure that the processes for new vaccines are as innovative and standardized as possible to guarantee efficacy, cost-effectiveness, and rapid time to market quality vaccines. It is a multi-disciplinary function that provides expertise in the process; manufacturing sciences, process modeling, statistical analysis; process validation, and technology transfer. Commitment and solidarity are key in the MTech department. The Global MTech organization is the seeding ground for technical and scientific talents that execute their work in a large network and offer multiple possible career evolutions. You will be integrated into a team where you will acquire scientific and technical skills, alongside our experts, our data scientists, our project teams, and a management team committed to your development. Furthermore, Global MTech is providing cross-functional training and development and is the portal for collaboration with many different organizations including R&D, Manufacturing, Supply Chain, Regulation, and Quality.

THE POSITION

The Process Validation Subject Matter Expert, within the Process Technology Platform of Manufacturing Technology (MTech), performs a key function within Vaccine Industrial Affairs. The role is responsible for managing, optimizing, and executing the Swiftwater Site Process Validation Program and partners with all functions across the site to continuously improve the level of knowledge and skills related to process validation, define the strategic vision for the Site Process Validation program, develop strategy and obtain endorsement for process design, performance, and qualification, and represent the Site during Health Authority inspections. The mission of the MTech function is to deliver robust and efficient processes with associated knowledge to transfer to Manufacturing. The MTech function also provides assistance to manufacturing towards industrial performance excellence. 

RESPONSIBILITIES 

· 
Evaluate, develop, and improve the Process Validation Program, including providing guidance during investigations, corrective and preventative actions, and manufacturing investigations

· 
Ensure compliance with all regulatory requirements and quality standards are followed to provide a safe, efficacious, quality product.

· 
Represent the Site during Health Authority inspections related to process validation and lead the implementation of any commitments that result from those inspections.

· 
Leads and/or supports Site development and manufacturing activities related to process validation, such as:

· 
providing expert guidance in the following areas:

· 
process validation design documents, such as Quality Target Product Profile (QTPP), to develop and scale up the preclinical manufacturing process

· 
qualification of the process using Quality by Design (QbD) principles

· 
process monitoring to ensure the robustness of the initial commercial process and perform lifecycle management (LCM).

· 
assessing proposals for process changes to determine impact and define deliverables

· 
design and qualification of aseptic process simulations (APS) and mixing studies

· 
networking with other subject matter experts within the Sanofi internal network (MTech ONE) and across the industry to understand trends, develop best practices, align local practices with global standards, and make recommendations for improvements to be implemented in Swiftwater. Participation in external forums to communicate and stay abreast of best industry practices is a key aspect of the role given Sanofi’s active involvement in the industrial community with respect to trends in industry practice, regulatory topics, and continuous improvement,

· 
Creates and maintains the Process Validation Program document to define the near-, mid-, and long-term vision for the development of Site practices and procedures.

BASIC QUALIFICATIONS

· 
Bachelor’s in basic sciences, math, engineering, or pharmacy with 6+ years’ experience or MS with 3+ years experience in biological processes in a cGMP environment. The candidate should possess educational and professional experience, commensurate with the position.

PREFERRED QUALIFICATIONS

· 
M.S. with 3 – 5 years of experience supporting process validation for commercial production of biological sterile injectables. Strong knowledge of regulatory expectations on process validation. Knowledge of sound statistical principles and their application. Active membership in external professional organizations, such as PDA and ISPE.

TERMS OF EMPLOYMENT

· 
The hired candidate will execute their role as an individual contributor.

· 
Preferred start date: October 2022

· 
The hired candidate will work during normal business hours (8 am – 5 pm Monday – Friday), but flexibility for occasional work outside of these hours is necessary.   

BENEFITS OF WORKING IN THIS ROLE 

Sanofi’s VIA mission is to improve worldwide human health, as a reliable manufacturer, by delivering high-quality, innovative, and affordable products to our customers. Therefore, the hired candidate will:

· 
fit in well with our Sanofi values of innovation, solidarity, confidence, respect, and integrity and our ways of working (Focus, Agility, Accountability, and Simplicity). 

· 
have the opportunity to establish the vision and set the strategic direction of the Site Process Validation Program

· 
have the opportunity to influence best practices related to process validation throughout various manufacturing facilities (drug substance and drug products), both within Sanofi as well as across the global Sanofi network.

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.

#GD-SP   

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.

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