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Sanofi Group Manager Laboratory US - Vaccine in Swiftwater, Pennsylvania

SHIFT :

Monday-Friday

Vaccinations may be required

JOB OVERVIEW:

Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines. Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patientsā€™ 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.

Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases. We distribute more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe. Our company has more than 13,000 employees worldwide working in 14 production and/or R&D sites with more than 50% of staff devoted to industrial operations (IO). Industrial Operations (IO) at our Swiftwater, Pennsylvania site, the largest vaccine manufacturing facility in the US, continues to develop its manufacturing assets to produce existing and new vaccines and biopharmaceuticals. Sanofi Pasteur provides associates in IO a variety of opportunities to develop and enhance their career through the ability to work in diverse roles across functions, resources for continuous learning, and assistance for those wishing to further their education.

Sanofi Pasteur SA 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:

The Laboratory Manager for the Quality Control Bioassay leads a team of analysts and managers, responsiblefor FluzoneĀ® identification and potency testing and other traditional immunoassays in the department. Major responsibilities include managing day-to-day operations of the QC Bioassay Laboratory, providing scientific and technical guidance on test issues and data interpretations while ensuring a high-level of cGMP compliance, support annual strain change validations. Specific emphasis on commercial lab functions in regards to inspection readiness, testing and release to meet the company needs and annual strain change validations as required by international agencies.The Laboratory Manager is also responsible for providing leadership for the activities of laboratory personnel with various levels of responsibility, assisting with implementation of site policies and procedures (SOPs and SWIs) to assure compliance with regulatory requirements.Must be able to represent the company with customers and regulatory agencies.In addition the candidate will identify and implement change to improve operation efficiency/compliance and represent QC at various product and process team meetings.

BASIC QUALIFICATIONS:

  • Bachelors of Science degree with a four-year college or university is required.

  • Minimum of 1-3 years management experience.

  • Demonstrated expertise in immunological techniques such as single radial immunodiffusion, hemagglutinin inhibition and various identity and ELISA based assays.

  • Excellent report writing skills

  • Expertise in the Trackwise/Phenix and LabWare LIMS systems

  • Exceptional verbal/written communication, time/resource management, attention to detail, interpersonal and organizational skills

KEY ACCOUNTABILITIES:

Testing

  • Be proficient in all analytical aspects of testing methodology and data review.

  • Utilize technical expertise to troubleshoot procedures, analytical discrepancies, instrument/equipment issues and other aspects associated with testing.

  • Develop systems to ensure instrument and critical testing material readiness.

  • Be competent in the utilization of supporting data management systems and the ability to review and release analyses as required.

  • Support annual strain change validations.

Supervision

  • Manage staff to ensure that daily performance issues are addressed.

  • Establish yourself as a coach and mentor by routinely meeting with staff on both a team and individual basis.

  • Attend Monthly Safety/Compliance meetings as well as all other assigned training and communicate information to team.

  • Participate in the recruiting/interview process.

  • Provide input into Performance reviews outlining accomplishments and developmental needs.

  • Continue personal education and development through internal and external courses/training programs.

Training

  • Ensure training requirements are met and maintained (SOPs, SWIs, Protocols, etc.).

  • Achieve level of proficiency in all analytical techniques related to your department to ensure compliance of established procedures and deploy training as required.

  • Maintain a high-level of analytical competency through routine audits of individual training modules and the development of additional modules as required.

  • Ensure the level of cross-training is sufficient to meet the business needs.

Scheduling

  • Ensure all pertinent information is available in order to schedule daily priorities and meet business demands.

  • Track overtime usage to help control costs and insure proper staffing levels.

  • Intervene as needed to respond to scheduling conflicts and changes in business demands.

Team Building

  • Facilitate daily huddles

  • Identify opportunities to improve teamwork within the department.

  • Rotate assignments to enhance team interaction and analytical proficiency.

Documents/Procedures

  • Facilitate revision of documents as necessary to ensure regulatory compliance and ease of use.

  • Review/approve documents as necessary.

  • Consolidate documentation where applicable to improve testing efficiency and reduce the risk of procedural deviations.

Projects

  • Identify opportunities in the areas of cost reduction, increased productivity and regulatory compliance.Submit plans to remediate and follow through to implementation.

  • Support Equipment System Life Cycle (SLC) and Method Validation/Transfers as needed.

  • Provide support/leadership to Product/Project Teams as assigned.

Compliance

  • Ensure laboratory in an audit ready state at all times.

  • Represent the department during audits and inspections for all regulatory agencies as required.

  • Respond to all audit findings as assigned to ensure that root cause is identified where possible and that corrective and preventive actions are identified, implemented, and effective.

  • Respond immediately to incident/OOS investigations ensuring that the investigation is thorough and completed in a timely manner.

  • Monitor the lifecycle of laboratory equipment, instruments and facilities to ensure the laboratory is in a state-of-the-art condition.

Other

  • All other duties as assigned.

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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