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Sanofi Group Analytical Lead, Associate Director in Framingham, Massachusetts

JOB TITLE: Analytical Lead, Associate Director

DEPARTMENT: Manufacturing Science and Analytical Technology

REPORTS TO (Position): Director

DESCRIPTION:

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.

POSITION OVERVIEW WITH KEY RESPONSIBILITIES:

  • Analytical Lead/Associate Director, 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 function within Industrial Affairs, Specialty Care Operations (SCO) 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/Associate Director, reports to the Head of AST and is based in Framingham, MA.

Analytical Lead/Associate Director will:

  • 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, 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.

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 cross-functional 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.

BASIC QUALIFICATIONS:

  • PhD with 5+ years' Biopharmaceutical industry experience OR Master's degree with 9+ years' Biopharmaceutical industry experience OR Bachelors with 12+ years' Biopharmaceutical industry experience

  • 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.

DISCLAIMER: Above information was designed to indicate the general nature and level of work performed by employees with this job description. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. This document does not create an employment contract, implied or otherwise, other than an “at will” employment relationship.

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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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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