MeridenRecruiter Since 2001
the smart solution for Meriden jobs

Senior Manager QC Microbiology - Vaccine

Company: Sanofi
Location: Meriden
Posted on: January 15, 2021

Job Description:

Position: Senior Manager QC MicrobiologyLocation: Pearl River, NYWho You Are:You are a dynamic leader with extensive experience in managing multi site cGMP Microbiology laboratories and EM programs in high throughput fast paced manufacturing and testing environments. Alongside managing the laboratories, you will be a resource for all matters related to Sterility Assurance for two sites. You will establish good practices and continuous improvement programs in your area of responsibility and manage and develop a team covering the Pearl River and Meriden sites. You are a multi-tasker 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.Job Highlights:Manage all microbiological testing and environmental monitoring activities at PSC sites in Perl River and Meriden. Assure all microbiological testing covering all production activities is in compliance with multiple compendia and verify/qualify methods as appropriate. Manage all test methods, SOP---s validations pertaining Microbiological and Utility monitoring tests.Manage all EM excursions OOS/OOT events and drive deviations to closure in a timely manner. He/She will also be responsible for managing any resultant Corrective Actions and Preventive Actions (CAPA---s) and Change controls.Provide subject matter expertise for issues related to sterility assurance at both sites.Serve as technical mentor to direct reports and ensure that the staff is adequately trained and qualified. Develop personnel in the functional area and initiate/manage succession plans for critical roles in the QC Microbiology group.Where necessary support EMPQ---s, Media Fills and APS---s in manufacturing areas and participate in interdepartmental projects representing QC Microbiology.Manage all data trending for the functional area and generate reports as per site procedures and regulatory expectations.Serve as the SME for QC Microbiology during regulatory audits and IND initiatives .Maintain the QC Microbiology testing areas in a safe and complaint manner. Initiate continuous improvements and laboratory efficiency efforts. Lead data integrity efforts.Basic Qualifications:BS/MS in Microbiology/Virology with more than 8-10 years of experience in a cGMP laboratory supporting biologics manufacturing with through understanding of regulatory expectations from multiple jurisdictions.Expertise in routine Microbial testing such as Endotoxin, Bioburden, Sterility, and facility support in EM Utility/Personnel monitoring, A thorough understanding of evolving methods in Microbiology.Preferred Qualifications:Good Organizational, verbal communication, and written skills is required. Basic computational skills including Microsoft Word and Excel are required.Ability to serve as the technical expert for outsourced testing such as adventitious agents and Mycoplasma testing.Experience in data trending, and statistical methodologies in a manufacturing environment.Experience with laboratory electronic systems. (SoftMax ,LIMS, MODA etc.)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.GD-SP LI-SPAt 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. Full time

Keywords: Sanofi, Meriden , Senior Manager QC Microbiology - Vaccine, Executive , Meriden, Connecticut

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Executive Jobs

Manager of Solution Delivery, Core Systems
Description: Manager of Solution Delivery, Core Systems br br Apply now br br br br Date: Nov 23, 2020 br br br br Location: Framingham, MA, US br br br br Company: TJX Companies, Inc. (more...)
Company: The TJX Companies, Inc.
Location: Framingham
Posted on: 01/22/2021

Management Leaders - Own your own Business
Description: Own A Franchise br 40 BUSINESS CATEGORIES br PROVEN BUSINESS MODELS br FIND OUT HOW BUSINESS br OWNERS CAN EARN MORE br Have you ever thought about owning your own business If so, now is the (more...)
Company: WilliamsonHeckt
Location: Passaic
Posted on: 01/22/2021

RN - Registered Nurse - Case Manager
Description: Case Management opening in White Plains, New York. This and other rn jobs brought to you by Case Manager's needed for client in White Plains, NY for 12hr day shift
Company: CoreMedical Group
Location: White Plains
Posted on: 01/22/2021

Clinic Business Manager
Description: Why Us With a mantra of Empowering Human Potential, Hanger, Inc. is the world's premier provider of orthotic and prosthetic O P services and products, offering the most advanced O P solutions, clinically (more...)
Company: Hanger
Location: West Orange
Posted on: 01/22/2021

14G Air Defense Battle Management System Operator
Description: Defend the skies using complex technology as an Air Defense Battle Management System Operator for the Army National Guard. You will primarily be responsible for integrating, operating, and maintaining (more...)
Company: Army National Guard
Location: Troy
Posted on: 01/22/2021

Accounting / Finance Advisory - Sr Associate to Sr Manager
Description: JOB DESCRIPTION br br Job : 34582 Title: Accounting / Finance Advisory - Sr Associate to Sr Manager Job Location: Greenwich, Connecticut - United States Employment Type: Salary: 80,000.00 - 130,000.00 (more...)
Company: NPAworldwide Recruitment Network
Location: Greenwich
Posted on: 01/22/2021

Maintenance Director (Environmental Services Director) - Luxury Senior Living
Description: Job Description Maintenance Director Environmental Services Director
Company: Maplewood Senior Living LLC
Location: Westport
Posted on: 01/22/2021

Lifestyle Program Director Darien CT
Description: Job DescriptionActivities/Program Director Lifestyle Director Maplewood Senior Living, an innovative, forward-thinking senior living provider, strives to inspire our associates to learn, develop, and (more...)
Company: Maplewood at Darien LLC
Location: Greenwich
Posted on: 01/22/2021

Director of Nursing, Inpatient Units, The Hospital of Central Connecticut
Description: Description Job Schedule: Full TimeStandard Hours: 40Job Shift: Shift 1Shift Details: Work where every moment matters.Every day, almost 30,000 Hartford HealthCare colleagues come to work with one thing (more...)
Company: Hartford HealthCare
Location: New Britain
Posted on: 01/22/2021

Compliance Manager (Insurance/Legal)
Description: JOB DESCRIPTION br br Job : 35051 Title: Compliance Manager Insurance/Legal Job Location: White Plains, New York - United States Employment Type: Salary: 100,000.00 - 130,000.00 - US Dollars (more...)
Company: NPAworldwide Recruitment Network
Location: White Plains
Posted on: 01/22/2021

Log In or Create An Account

Get the latest Connecticut jobs by following @recnetCT on Twitter!

Meriden RSS job feeds