Purification Applications Leader

Job Title :

Purification Applications Leader

• title will align with Sanofi internal title

Location : Framingham, MA

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.

Sanofi's Global MSAT (Manufacturing Sciences, Analytics, and Technology) acts as a crucial link between our R&D and Manufacturing entities, playing an instrumental role in enhancing our current portfolio and delivering future launches of high-quality and innovative drugs and vaccines. Global MSAT is a beacon of innovation and process excellence in Manufacturing, this includes guiding the journey of new products from their launch to commercial success, being at the forefront of Data Sciences and Digitalization.

Join a team of talented and passionate international experts, scientists, and project leaders dedicated to inventing, designing, industrializing, and implementing cutting-edge industrial chemical and biological processes, analytical methods, and process modeling to successfully launch 3 to 5 new products by year.

The Principal Scientist in Downstream Process (DSP) will be part of the subject matter expert team and is responsible for providing technical leadership in monitoring and improving chromatography and filtration process performance at pilot and manufacturing scale.

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 :

Represent MSAT as a DSP subject matter expert (chromatography and filtration) in various technical forums within the broad Sanofi network. Drive DSP operation standardization and best practice across platforms (Mammalian, Microbial, Vaccine). Serve as a core point of contact to support MSAT programs and global manufacturing sites, and to collaborate with R&D / CMC teams.

Lead complex manufacturing investigation such as large column packing performance; pre-packed column quality, raw material (resin and filter) quality and performance, chromatography and filtration skid equipment cleaning / sanitization / storage, filter integrity test variation, bioburden and contamination control, Unit operation automation, and other scalability and manufacturability issues. Provide key technical guidance to manufacturing support teams by integrating knowledge from process, operation, equipment, and raw material.

Responsible for DSP pilot operation design and practice. Work with MSAT pilot teams to establish the scale-up guidelines for various DSP operation. Draft training protocols for manufacturing staff at pilot facility. Work with MSAT and CMC pilot teams to drive the necessary pilot data package to evaluate facility fit and manufacturability. Lead pilot scale studies to drive investigation and process definition.

Lead DSP innovations from conceptualization to implementation. Work with MSAT teams to design and implement innovations such as custom designed chromatography or filtration skid, continuous DSP configuration and PAT, custom fabricated resins, filters, absorbers, and fibers. Lead collaboration with Sanofi suppliers and external partners to enable preferred raw material supply with acceptable standards.

Support other downstream unit operations such as centrifugation, viral inactivation, freezing / thawing, and protein stability. Support next generation process development, control strategy implementation, process validation, Tech Transfer, process comparability for global MSAT program launch at both Internal and external manufacturing sites

Support Quality and Regulatory during health authority inspection and prepare for supportive documents for new filings or responses. Lead internal report preparation to support various regulatory activities.

Serve as a technical mentor to MSAT team members, provide training and supervision to project team members as needed. Participate in internal and external scientific exchanges to enhance MSAT competencies and reputation.

About You

Qualifications / Education & work experience

Master or PhD degree in Biological / Biomedical, Sciences / Engineering

10+ years of experience related to biopharmaceutical industry. Minimum of 5 years of hands-on experience in downstream manufacturing support or field technical support from a major supplier

Process knowledge across multiple modalities (e.g. mAbs, small protein and peptide, bioconjugates, nucleotides, Gene / cell therapy, organic chemistry etc.)

Extensive knowledge with pilot and manufacturing scale chromatography and filtration equipment and operation

In-depth understanding of various chromatographic separation mechanisms including affinity, ion-exchange, Hydrophobic, and Mix-mode. In-depth understanding of different filtration fundamentals (TFF, sterile filtration, membrane and fiber applications) and different operation modes (single-pass, alternative pass, continuous, nominal and tangential)

Prior experience of managing contractor manufacturing or contract research partners

Excellent scientific background and effective communication skills. Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines

Highly motivated individual with the ability to work independently as well as within cross-functional and cross-site teams

Oral and written fluency in English

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.

North America Applicants Only

The salary range for this position is :

$147,000.00 - $245,000.00

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK () .

Global Terms & Conditions and Data Privacy Statement ()

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi ()

As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.

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