Job Title: Manager- Scientist

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.

Manufacturing and Supply (M&S) at our Swiftwater, Pennsylvania site, the largest vaccine manufacturing facility in the US, continues to develop its manufacturing assets to produce existing and new vaccines and biopharmaceuticals. Sanofi provides associates in M&S a variety of opportunities to develop and enhance their career through the ability to work in diverse roles across functions, resources for continuous learning, and assistance for those wishing to further their education.

The Manager / Scientist, within the Manufacturing Sciences, Analytics, and Technology (MSAT) function of Industrial Affairs, ensures reliable and sustainable supply of vaccines to the Global Market. This position is responsible for site support during Heath Authority audits including remediation activities and authoring of responses. Provide recommendations for filling technical process improvements and support deviation resolution. This position reports to the Deputy Director, Pre-Filled Syringe Unit Leader.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

Leading or supporting technical process improvements and portfolio execution

• Subject matter expert / Technical expert and point of contact within field of expertise during project execution

• Accelerates Innovation within MSAT to promote new ways of working and to create and innovate mindset to gain efficiency and increase products knowledge

• Provide answers and information to identify the root cause for problems experienced during studies

• Researching and recommending innovative equipment, procedures, and solutions for troubleshooting commercial vaccine syringe filling issues.

• Work directly with vendors and external partners designing and procuring single-use manifolds and filling system prototypes for evaluation.

• Author documents identifying the plan for developmental studies (protocol) and summarizing the results after it is performed

• Lead meetings to prepare for process validation studies for filling line process improvements.

• Obtain the necessary materials to perform for process validation studies for filling line process improvements.

• Perform studies to necessary to prove consistency and obtain approval from government agencies for filling line process improvements.

Responsible for defining and managing deliverable and objectives

• Authoring and distributing weekly deliverable update to project team and cross functional teams.

• Manage the schedule and coordinate time with the equipment and team members to perform process validation studies that will meet the project timelines

• authoring of Filling Protocols and Technical Summary Reports

• data generation, compilation, review and approval supporting executed studies

• coordination of samples and drug product through internal and external logistics preparation

• Provide assistance with deviation investigations and root cause analysis through data collection, creation of graphs, and provide technical assessment as needed

Cross Functional Teamwork across platforms

• Fosters relationships with partners, experts from other functions and customers in order to achieve technical objectives

• Coordination of daily tasks for vaccine filling studies across platforms; including appropriate documentation, procedures, components, materials and drug products.

• Coordinate filling study schedule to the project and operational teams including resource staffing.

• Authoring and distributing daily updates during project studies to team and management.

• Work with different platforms to investigate problems and identify fixes

Communication to Site Leadership and Global MSAT Leadership

• compilation of data in tables and graphs to support communication to site leadership.

• providing filling updates / recommendations to Project Team Leader for site leadership communication.

• Creation and presentation of PowerPoint slides summarizing any delays or problems with the project and how it is resolved

• Responding to emails and answering questions from the Project Team Leader

• Look ahead to identify potential problems and provide solutions to avoid those problems, share the information with Project Team Leader for site leadership communication

Coaching and Training and Development of Employees

• Contribute to maintaining technical knowledge in the workforce

• Collaborate with Global MSAT experts / MSAT network to develop scientific coaching when needed.

• coaching and mentoring junior personnel within the department.

• Providing hands on training for junior staff during studies such as pipetting, sample collection, sample coordination

• review of junior personnel documents

• Writing/revising documents that provide step-by-step instructions for how to perform new processes

• Demonstrating new procedures for production personnel when the steps for a study are different from the typical process

Support Site Internal and External Audits

• providing site support for Health Authority audits (i.e. FDA, EMA,)

• Provide documents and information to show adherence to Health Authority guidance

• Answer questions from auditors during Health Authority audits

• assisting in audit responses including data compilation and authoring documents.

• Brainstorm and provide potential solutions to problems identified during audits and documented in audit responses

Education and experience

• Bachelor’s degree in engineering or STEM related field with a minimum of 5 years' experience or master’s degree in engineering or STEM related field with a minimum of 2 years' experience

• 1-5 years of experience with drug substance, drug product development and validation processes.

• Delivery and Maintenance of robust and efficient processes for vaccine filling

• Validation, Clinical and Commercial manufacturing of bulk drug products

• Experience with photostability studies

• Knowledge of the design, operation and peripheral processes associated with process engineering activities.

Preferred Skills:

• Strong technical writing skills.

• Attitude of collaboration.

• Process Development

• Equipment troubleshooting, installation, controls.

• Experience but not required automation, electronic equipment, PLC or machine control processes

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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Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.