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Senior QC Manager Stability and Analytical Excelllence

Pearl River, New York, Meriden, Connecticut

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Overview

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Responsibilities

Position Title 

Senior Manager Stability and Analytical Excellence

Location

 Meriden or Pearl River NY

Who You Are

You are a transversal leader who will manage  multiple functional areas within QC. You will have a solid background in Stability of Biologics having managed a stability function . You have a quality mindset and will provide guidance to department employees of cGMP practices and continuous improvement efforts. Your expertise will range from Analytical methods , Instrument qualifications, electronic systems and other non-testing activities. You are a multitasker with the ability to adapt to changing priorities in line with business needs.

Who We Are

We are a QC organization supporting testing activities for commercial and development (pipe line) projects spanning multiple areas of treatment for Sanofi Biologics. The scope of our activities include all routine QC/Micro testing for Drug Substances, Drug products, In process , Raw material and stability samples conducted internally as well as external testing sites.

Where We Are

Pearl River is located in Orangetown, south of Nanuet and west of Blauvelt. Pearl River is a hamlet near the New Jersey border. Commuters still run to catch the train at the old station near the post office. The town is located within 35 miles of New York City.

Meriden is located at the Crossroads of Connecticut, being bisected by two of the State’s major freeways (I95 and (91), Meriden is situated midway between the cities of New Haven and Hartford, located about 20 miles to the north and south, respectively. Train service is available from the State St. station.  The City is located within 25 miles of several world-class educational institutions.

Job Highlights

Management of the Stability program for DS/DP of internal production lots as well as programs initiated for CMO’s. The role encompasses the design of stability as per regulatory guidelines, execution, analysis and trending of data. Management of Stability issues including OOS/OOT with the support of peers in the testing groups.  Serve as the SME for stability related issues during regulatory audits and IND initiatives .

  • Provide guidance to the laboratory lab staff in maintaining the laboratory in a compliant state.

  • Support laboratory staff in resolution of routine quality events (OOS/OOT/CAPA’s) and introduce and maintain a quality mindset to departmental staff.

  • Support Quality integration initiatives.

  • Ownership of Analytical method validation and transfers meeting regulatory expectations.

  • Remediation of methods as needed with the assistance of network development teams.

  • Over all method life cycle management.

  • Create a robust Reference Standard program in collaboration with the network Analytical/Quality experts in order to sustain testing activities.

  • Manage Computer System Validation activities and support all departmental endeavors on transition to Electronic systems.

Basic Qualifications

  • BS/MS in Chemistry/Biochemistry/Biology or related discipline  with more than 8-10 years of management experience in a cGMP laboratory

  • Well versed in ICH requirements for stability and demonstrated experience (3-4 Years) in managing a Stability Program is essential.

  • Method Validation and Analytical Transfers experience including  routine QC methods in Vaccines/Biologics assays.

Preferred Qualifications

  • A thorough understanding of routine QC operations, Laboratory compliance management, Quality events and Risk assessments.

  • Experience in Instrument qualification , life cycle management and Computer System Validation.

  • Basic understanding of Reference standards in a developmental and commercial environment.

  • Good Organizational, verbal communication, and written skills is required.

  • Basic computational skills including Microsoft Word and Excel are required.

  • Experience with laboratory electronic systems.

Terms of Employment

  • Approximately 30% travel between the Meriden and Pearl River testing sites.

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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