Analytical Lead

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.

Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees.  With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve.  Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients.

Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme.

Genzyme Corporation (a Sanofi company) 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, religion, sex, national origin, disability or protected veteran status, or any other characteristics protected by applicable law.

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:

• Analytical Lead will serve as a member of CMC/Technical Product Team(s) for a product or a portfolio of products and will be responsible for overseeing, leading and coordinating execution of analytical activities for late stage and commercial biologics.

• Development and manufacture of biopharmaceuticals is one of the primary focus areas for Sanofi. In-depth knowledge, understanding, development and implementation of analytical control strategy, as well as leading, overseeing and supporting a variety of analytical activities for late stage and commercial therapeutics, is essential for the success of biologics development and manufacture.

• MSAT is looking for a strong Analytical Leader and technical SME to provide support to a number of products in Sanofi’s late stage and commercial biologics portfolio.  

• This role is within the Analytical Science and Technology (AST) team in the Global Manufacturing Science & Analytical Technology (MSAT) department.  The MSAT is responsible for leading technology transfer, implementing control strategy, providing technical process and analytical support and driving process and analytical lifecycle management for biologics drug substance and drug product operations.  Analytical Lead reports to the Head of AST and is based in Framingham, MA.

• Serve as the primary contact for assigned product / product family for the MSAT Global Analytical function. Represent Global MSAT Analytical in CMC/technical product teams, maintain thorough knowledge of assigned product(s), coordinate execution of analytical work within MSAT and externally to support characterization, comparability, investigations, and process development.

• Collaborate routinely with other line functions (within and outside of MSAT, including Quality, Regulatory, CMC/Development) as well as external partners and lead cross-functional teams.

• Exert influence on the overall objectives and long-range goals of CMC/technical product teams for assigned product(s).

• Contribute to/oversee analytical control strategy establishment, specification setting, risk assessment and comparability activities related to new product introduction, process changes, tech transfer, etc. as appropriate.

• Lead / oversee ALCM activities, internally and externally/outsourced as applicable, including assay development, transfer, SME support for assigned product(s).

• Lead / support development and implementation of internal processes related to analytical development.

• Author/ contribute to / review regulatory documents as analytical SME.

LEADERSHIP QUALIFICATIONS

• In this position, an individual will build and lead the teams of SMEs and analytical scientists working on assigned product(s) as well as participate in crossfunctional team leadership.

• Strong technical leadership, influence and leading without direct authority, giving and receiving feedback, striving for results, finding effective solutions while working with ambiguity or conflicting priorities, leading by example are the required leadership qualifications for the position

About You

BASIC QUALIFICATIONS

• PhD with 5+ years of experience, Master with 9+ years, or Bachelors with 12+ years of experience, in Biopharmaceutical Industry

• Academic degree in life sciences, biology or the like

• Working knowledge and understanding of biologics process development.

• Understanding of analytical control strategy, familiarity with specification settings, technology/method transfer, characterization and comparability studies

PREFFERED QUALIFICATIONS

• Expertise in analytical development, such as biochemical, biophysical or biological method development, qualification, transfer and implementation

• Familiarity with project management

TECHNICAL SKILLS & COMPETENCIES / LANGUAGE / SPECIFIC EXPERIENCE AND KNOWLEDGE:

• Working knowledge and understanding of biologics process development

• Understanding of analytical control strategy, familiarity with specification settings, technology/method transfer, characterization and comparability studies

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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