Senior Manager Operations - Manufacturing Science, Analytics and Technology:
Sanofi

1544819887
Sanofi
Framingham Massachusetts
Pharmaceutical
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Description
DEPARTMENT DESCRIPTION

The Senior Manager Operations is a member of Analytical Science and Technology (AST) in the Manufacturing Science & Technology (MSAT). The MSAT function within 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 operations. The Manager, Operations, reports to the Senior Manager of AST Operations and is based in Framingham, MA.

AST is a partner of Process Sciences in MSAT and Biologics Quality and Manufacturing Departments. AST provides analytical support to commercial manufacturing of biologic drug substance (DS), is responsible for method and platform technology development for analytical life cycle management (LCM), and supports process development for LCM.

* Support 2nd generation process development for biologics DS

* Support commercial biologics and analytical LCM

* Facilitate implementation of digital tools and infrastructure

* Advance analytical automation, high throughput capabilities, and PAT

* Partner with internal and external functions to transfer and implement novel analytical methods and technology

* Develop analytical control strategy and support regulatory filings

POSITION OVERVIEW WITH KEY RESPONSIBILITIES

The development and manufacture of biopharmaceuticals are one of the primary focus areas for Sanofi. In-depth knowledge, understanding, development, and implementation of analytical, biological, and immunological assays and strategies is essential for the success of Biologics development and manufacture. MSAT is looking for a strong analytical SME with exceptional organizational skills to manage key aspects of AST laboratory operations and support strategic initiatives related to analytical and process LCM. The Manager, Operations, will be responsible for overseeing processes and activities that enable the group to meet key strategic objectives. Work is conducted in a highly cross-functional and matrixed environment. Specific responsibilities include:

* Lead technical activities related to commercial Biologics product lifecycle management programs, which may include cross-functional team leadership

* Develop comprehensive test method catalogs and method sourcing strategies for late-stage clinical and commercial Biologics products, which may include internal and external partnerships

* Implement processes for managing insourced laboratory support activities, which may include day-to-day oversight of external staff

* Oversee budget, expense, and asset tracking, which may include annual budget and project planning

* Oversee laboratory space planning

* Lead or support characterization and comparability studies

* Support establishment and LCM of control strategy for late-stage and commercial Biologics

* Support regulatory filings as appropriate

* Participate and contribute to the leadership and governance practices in AST and MSAT as appropriate

BASIC QUALIFICATIONS

* Degree in chemistry, biochemistry, biology, or associated field; B.S. with 8+ years of experience OR

* M.S. with 6+ years, OR

* Ph.D. with 4+ years of experience AND

* Direct experience in a Biologics analytical laboratory for a minimum of 3 years, with a minimum of 1 year leading technical and/or operations projects

* Broad experience and general knowledge in protein analysis methods, analytical method lifecycle (e.g. development, qualification, validation)

* Broad understanding of the technical and regulatory aspects of Biologics development and manufacturing

* Demonstrated ability to lead programs and/or projects

PREFERRED QUALIFICATIONS

* 3+ years leading technical and/or operations projects and activities

* Prior management experience

LEADERSHIP QUALIFICATIONS

* May manage direct reports (internal or external) as well as staff and activities in the network and matrix environment

* Excellent communication (verbal and written) and networking skills

* Ensure compliance with all legal and business requirements and Sanofi policies and practices

* Enable effective utilization of resources by ensuring robust employee development, performance management, succession planning, and rewards and recognition practices in the area of responsibility as well as talent attraction and talent exchange with other sites

* Demonstrated ability to influence

* Motivate, retain, and develop key employees.

* Build and sustain employee engagement by creating an environment within which individuals and teams can excel.

SPECIAL WORK CONDITIONS

* The primary location is in Framingham, MA

* Up to 10% domestic travel may be required

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

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.