Sanofi Jobs – For Cell Culture Process Development Senior Scientist Careers Waltham, MA

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Sanofi Jobs – Apply Now for Cell Culture Process Development Senior Scientist Careers Waltham, Massachusetts

Best Jobs in Sanofi:- Sanofi Careers site has published Sanofi Jobs notification for Cell Culture Process Development Senior Scientist Position. Candidates who have PhD degree can apply online through Sanofi Recruitment site. The location of this Cell Culture Process Development Senior Scientist Position is Massachusetts.

Sanofi Jobs description related to this Cell Culture Process Development Senior Scientist Position like Job request number, Job Location, Educational background, required age, Salary and benefits provided in details below. You should check all details before apply.

Sanofi Jobs Summary According to Sanofi Careers Site

Recruiting Agency :- Sanofi

NSanofie of Profile :- Cell Culture Process Development Senior Scientist

Job Location :- Massachusetts

Salary :- $85,404.00 per year

Full Job Description

The Genomic Medicine Unit (GMU) CMC group at Sanofi is dedicated to the establishment of best in class manufacturing platforms to support development of life-changing advanced cell and gene therapy products, including recombinant AAV vectors, lentiviral vectors and cell therapy products.   Sanofi is looking for an experienced cell culture development professional with experience in viral vector production to join the Genomic Medicine Cell Culture Process Development Group located in Waltham, MA in the role of Senior Scientist.  The Genomic Medicine Cell Culture Development group within Sanofi operates with the mission to develop robust, scalable and innovative viral vector cell culture processes for Sanofi’s genomic medicine pipeline.

The successful candidate will be responsible for managing pilot scale bioreactor operation, modification of bioreactor configuration, bioreactor characterization and process automation to ensure successful development, scale-up and tech transfer of viral vector manufacturing process

Key Responsibilities:

  • Develop operation strategies for pilot scale bioreactors.
  • Manage routine operation and maintenance of pilot scale bioreactors.
  • Lead bioreactor characterization for successful scale-up and scale-down modelling.
  • Lead modification of bioreactor configuration.
  • Develop process automation strategy.
  • Evaluate and implement latest process technologies.
  • Contribute to project, technical, and strategic teams as appropriate.
  • Effectively manage a multi project development portfolio.
  • Make strong technical strategic contributions to cross functional development project teams to ensure efficient and timely execution of deliverables.
  • Establish and drive innovation in furthering scientific and process understanding to enhance viral vector productivity and quality.
  • Plan resources for supported projects to ensure timely delivery of department objectives.
  • Serve as a subject matter expert in one or more selected areas of cell culture development and support the entire upstream development portfolio.
  • Present findings and/or results to senior management, external stakeholders, and industry leaders at national/international conferences.
  • Contribute to manuscript and patent writing for external publications��and patent applications.

Basic Qualifications:

  • PhD degree in Chemical Engineering or related discipline with a minimum of 4 years of relevant industry experience or a master’s degree with a minimum of 8 years of experience or a bachelor’s degree with a minimum of 10 years of experience.
  • Strong knowledge of fundamental engineering principles relevant to cell culture process.
  • Experience in operating bench scale and pilot scale bioreactors.
  • Excellent communication skills.

Preferred Qualifications:

  • Experience in managing one or more junior staff either directly or as a matrix team lead.
  • Experience in the biotech/pharmaceutical industry within a cell culture role and an excellent understanding of the theory and practice of cell culture process development.
  • Experience managing cross functional team and initiatives.
  • Experience in the development of HeLa producer cell line production processes and/or HEK AAV transient transfection production.

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-SP

PDN

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.

Apply Now


Sanofi Jobs – Apply Now for Order Lead Coordinator, Trial Master File Manager Careers Bridgewater, New Jersey

Best Jobs in Sanofi:- Sanofi Careers site has published Sanofi Jobs notification for Order Lead Coordinator, Trial Master File Manager Position. Candidates who have High school Diploma can apply online through Sanofi Recruitment site. The location of this Order Lead Coordinator, Trial Master File Manager Position is New Jersey.

Sanofi Jobs description related to this Order Lead Coordinator, Trial Master File Manager Position like Job request number, Job Location, Educational background, required age, Salary and benefits provided in details below. You should check all details before apply.

Sanofi Jobs Summary According to Sanofi Careers Site

Recruiting Agency :- Sanofi

Name of Profile :- Order Lead Coordinator, Trial Master File Manager

Job Location :- New Jersey

Salary :- $50,500.00 – $90,000.00 per year

Full Job Description

The Lead TMF Manager is the business owner of the Trial Master File (TMF) management (paper or electronic TMF). The Lead TMF Manager is a key member of the Study Team and is responsible for reporting eTMF status.
He/she prepares the TMF plan to define TMF strategy depending on the study (e.g. study managed internally Vs study outsourced, QC plan depending on study type. He/she oversees TMF completeness, Independent Quality Control (IQC) activities performed by the TMF Specialists and follows-up on specific actions with the contributors to ensure TMF compliance and completeness at all time.  He/she is responsible for the eTMF lock. He/she provides eTMF training and support to contributors to ensure the TMF plan and best practices are well implemented and followed. He/she ensures filing activities are performed by contributors according to quality standards and reinforce inspection readiness. When there are internal audits, the Lead TMF Manager is the Sanofi representative facing the auditors to provide training to use the eTMF and information on TMF management processes.  He/she is responsible for answering auditors’ questions.

More specifically, the Lead TMF Manager is responsible for:

  • Ensuring that list of documents expected for each study in the eTMF tool are in accordance with study specificities.
  • Organizing the TMF kick-off meeting and setting-up the TMF Plan.
  • Ensuring that filing and pre-archiving of clinical trial documents are completed according to internal standards and timelines.
  • Ensuring that clinical trials documents are available for internal audits and inspections (sponsor and sites).
  • Is the PAI (Pre-Approval Inspection) contact for TMF aspects.
  • In case of inspections by Health Authorities, He/she is the Sanofi representative facing the inspectors to provide information on TMF management processes.  He/she is responsible for answering inspectors’ questions on TMF management processes.
  • Mentors junior members of the department and participates in specific projects related to the area of records management (i.e.  IT project, quality project to align with new regulations, inspection readiness.

Knowledge And Skills:

  • Demonstrated ability to work in full autonomy and take initiatives.
  • Efficient collaboration with internal and external partners.
  • Organizational, excellent interpersonal and communication skills (verbal and written).
  • Results driven in terms of timelines and quality; Customer & quality focused.
  • Flexibility, diplomacy, efficient in matrix organization and transverse management.
  • Is a change management agent.
  • Self-motivation, attention to details while overseeing and connecting with cooperating departments; Understands the clinical development process and GCP’s.
  • Familiarity with application/systems related to record management (eTMF tool).
  • Learns quickly when facing new problems.
  • Effective written and oral communication in English, and good interpersonal skills.
  • Experience with the management of outsourced activities would be appreciated.

Key Responsibilities:

  • Performs the study set-up in the eTMF tool
  • Organizes the TMF kick-off meeting with the appropriate TMF Contributors and creates the TMF plan for each study in order to describe TMF management strategy and operational activities. The content of the TMF plan is discussed during the TMF kick-off meeting, reviewed by the appropriate TMF Contributors and finalized by the Lead TMF Manager. This TMF plan is updated throughout the study as needed.
  • Provides on-going support (operational and technical) to eTMF contributors He/she ensures training of local staff is provided on SOPs and application/systems related to record management.
  • Collaborates with all stakeholders of Record Management Department.
  • Provides status during Study Team meetings and generates regular TMF/eTMF & IQC Statuses for contributors to ensure TMF completeness and quality.
  • He/she identifies systematic issues, propose action plans and ensure follow-up until resolution.
  • Identifies and resolves issues / problems which prohibit normal filing activities by using acquired experience and expertise.These issues/problems may include, but are not limited to incomplete filing, illegibility and inappropriate form completion.
  • Informs the TMF Contributors on pre-archiving activities, the timelines to provide their specific TMF documents and to ensure that all electronic documents are available in the eTMF (for electronic studies).
  • When the eTMF is complete, he/she approves the eTMF lock request form, and organizes a TMF/eTMF closure meeting.
  • As necessary, the Lead TMF Manager assesses the need for eTMF unlock, and complete the “eTMF unlock request form” including the reason for unlock. He/she completes the “eTMF relock request form” consequently.
  • Participates to any internal audits. Participates to the activities related to the TMF during the PAI (Pre-Approval Inspection) preparation.During inspections by Health Authorities (sponsor and/or sites), he/she is the key contact from Record Management facing inspectors to answer their questions relating to TM management processes.
  • He/she liaises with the RM service team for long term archiving. He/she provides final archiving date to Planning Department.
  • Participates in procedure writing (Department SOP, User Manuals) and reviews specific conventions and rules in relationship with contributors. He/she participates in the design, execution and documentation of testing needed to support life cycle management of new and existing eTMF applications/systems.

Basic Qualifications:

  • High school diploma or equivalent and a minimum of 4 years’ experience in pharmaceutical industry or clinical-related discipline, good understanding of the R&D processes and previous exposure to GCPs/ICH is required.
  • At least 3 years of experience with TMF management and/or Bachelor degree.

Preferred Qualifications:

  • Clinical Research experience in clinical operations is desirable.
  • Knowledge of ICH Guideline pertaining to the essential documents for the conduct of a clinical trial.
  • Curiosity, willingness to be proactive and problem-solving mindset.
  • Knowledge of Sanofi SOPs.

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-SA
#LI-SA

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.

Apply Now


Sanofi Jobs – Apply Now for Order Management Analyst Careers Bridgewater, New Jersey

Best Jobs in Sanofi:- Sanofi Careers site has published Sanofi Jobs notification for Order Management Analyst Position. Candidates who have Bachelor’s degree can apply online through Sanofi Recruitment site. The location of this Order Management Analyst Position is New Jersey.

Sanofi Jobs description related to this Order Management Analyst Position like Job request number, Job Location, Educational background, required age, Salary and benefits provided in details below. You should check all details before apply.

Sanofi Jobs Summary According to Sanofi Careers Site

Recruiting Agency :- Sanofi

Name of Profile :- Order Management Analyst

Job Location :- New Jersey

Salary :- $62711.00 a year

Job Description

Summary of Purpose/Major Responsibilities:

The Analyst, Order Management, handles day to day operations of order management dedicated to internal customer needs as it relates to orders fulfillment, internal inventory levels, and customer supply needs and contractual commitments.

 

Major responsibilities are as follows:

  • Order Management
  • Customer Inbox and Esker OCR Technology Management
  • GBU Alignment and Support

 

Order Management

Ensures order management is aligned with business requirements, failure to supply, and production scenarios. This position is responsible for complying with all applicable SOX and internal controls, and maintaining or exceeding all relevant department KPIs.

 

Customer Inbox and Esker OCR Technology Management

Manages customer support inbox consisting of orders and inquiries from trading partners maintaining established service levels and continuously closing the loop with inquiry resolution. Primary SME/focal point of Esker OCR technology to manage and validate system checks for automated order creation.

 

GBU Alignment and Support (Relationship Management)

Provides support to internal stakeholders, as defined by individual or unique customer needs, benchmarking efforts, and collaboration with the department on specific ways to ensure the best level of service. Execute launch strategy with initial launch customers. Integrate continuous feedback and communication to the business on shipments and potential order delays. Responsible for daily communications to business of order fulfillment.

 

Based on the role mapping, the role may be composed of the following:

 

Order Taking

Responsible for taking and entering manual domestic orders via phone, email, fax according to the customer requirements, based on business rules for third party sales process. Validation of data extract in OCR tool (Esker) and solve issues.

 

KEY ACCOUNTABILITY:

GBU Alignment and Support (Relationship Management)

Through knowledge of business landscape, customer requirements, and supply chain capabilities, identify and develop solutions to customer needs. Responsible for transparency on order to cash that impacts financial expectations with internal customers/partners, including but not limited to the following activities:

  • Close collaboration on orders and inventory
  • Failure to supply or backorder reporting
  • Communications/notifications to GBU around weather, transportation, or any other supply chain delays
  • Participate as needed in internal business reviews to review service levels and metrics
  • Participation in launch planning and wholesaler stocking fulfillment
  • Work with trade team and transportation SMEs, provide recommendations to change delivery schedules in times of inclement weather and holidays
  • Work closely with Winthrop on optimizing supply chain support in relations to their trade strategy
  • Build information pamphlets, email and call scripts, etc.

 

Esker OCR Automation Technology

Serves as primary focal point for Esker OCR tool including but not limited to the following responsibilities:

  • Master technology and understanding of system functionality
  • Investigate and resolve first line technical issues
  • Maintain service level lead times for customer inquiry resolution and order placement

 

Continuous Improvement:

  • Attend relevant supply chain conferences or trainings
  • Attends regular meetings with key stakeholders and leadership to review results, trends, and identify opportunities to improve processes, service levels, results, costs and customer satisfaction
  • Visits accounts and distribution centers as needed to collaborate or opportunities to improve results
  • Collaborates with internal distribution centers on areas of opportunity for improved or more efficient service

 

BASIC QUALIFICATIONS:

  • Bachelor’s degree required with
  • Minimum 3 years’ Customer Service experience OR
  • High School diploma with at least 7 years’ Customer Service experience AND
  • Experience in pharmaceutical industry, preferably in Supply Chain or Order Management organization

 

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-SA

#LI-SA

 

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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