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Job Title: mRNA - LNP Drug Product Fill Finish Specialist

Location: Waltham, MA

About the Job

The mRNA - LNP Drug Product Fill-Finish Specialist will support Fill Finish manufacturing campaigns at Sanofi sites and external CMOs. The specialist will work under the guidance of the Drug Product Development and Industrialization Team, within the CMC Process Development & Industrialization group in the Sanofi mRNA Center of Excellence. All products will be mRNA-based vaccines and/or therapeutics.

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.

Main Responsibilities:

• Represent as a Subject Matter Expert (SME) and provide technical support to enable knowledge and process transfer for fDP manufacturing.

• Support the harmonization of fDP processes across different manufacturing sites (local and international).

• Support technical activities required to onboard new CMOs/manufacturing sites for fDP manufacturing.

• Responsible for authoring and/or reviewing technical reports, batch records, knowledge transfer documents, work instructions, and risk assessments to support process implementation at manufacturing site(s).

• Participate in CMC project teams on fDP fill finish topic, contribute to the development of detailed CMC project plans and overall program execution.

• Engage with key stakeholders to ensure transparency on program status and alignment on program plans, goals, resource requirements and timelines.

• Troubleshoot process issues that occur during tech transfer and in production of drug product. Consult with QA and Regulatory teams as needed.

• Contribute to IND filings/regulatory documentation.

About You

Required Qualifications

• Work Experience: 15+ years of experience in fill/finish of pharmaceutical drug products

• Education: Master's degree in a scientific or related field is the minimum requirement. PhD or PharmD preferred

• Language Requirements: English (required); knowledge of French is desired

Preferred Qualifications:

• Deep understanding of cGMPs and manufacturing activities including: aseptic filling, filter validation and visual inspection

• Prior experience with mRNA-LNP products is desired

• Reviews and contributes to deviations during fDP manufacturing and contributes to any follow-up investigations

• Excellent technical writing skills as applied to the generation of investigation reports

• Proficient in Microsoft Office (Excel, Word and PowerPoint)

• Strong time management and prioritization skills

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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.