Job title: Senior Lab Manager for Virology BSL3 labs- Vaccines
Location: Swiftwater, PA
About the Job
Sanofi is recruiting a BSL3 laboratory manager for the GCI Virology platform to support a diverse and growing portfolio of vaccines targeting infectious diseases. The lab manager will drive quality, consistency, and compliance, managing a team responsible for developing, validating, and executing cell-based neutralization and binding assays for viral targets to support vaccine clinical endpoints from Phase I to Phase IV. He/She will oversee the scientific review and integrity of the data generated in their assigned area, and assist in evaluating new technologies to enhance throughput, precision, accuracy, and overall quality of methods employed by their teams.
The position involves managing the BSL3 laboratories in GCI, planning and coordinating activities according to corporate and regulatory requirements. The lab manager will act as a liaison between external support groups such as HSE, Occupational Health Services, Technical Services, Managed Service providers, and vendors, and will be trained to become the biosafety point of contact within Global Immunology for late-stage clinical testing.
The successful applicant will support regulatory requirements, including those of the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) Global Action Plan III (GAPIII) programs. They will also participate in applicable audit teams, including those from the CDC, WHO, corporate, and other relevant audits.
We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.
Main Responsibilities:
Manage the BSL3 laboratories and Operations
Support compliance with WHO and CDC GAPIII guidelines,
Participate in applicable audit teams, including those from the CDC, WHO, corporate, and other relevant audits.
Perform risk assessments and define continuous improvement plans to mitigate risks.
Work with laboratory and support personnel to plan and coordinate activities within the BSL3 facility.
Under direction of management, plans and oversees the day-to-day operations and general activities associated with one or more laboratories/projects. Ensures laboratory resources (materials/reagents/equipment/facilities) are maintained to meet assigned objectives; evaluates performance/metrics of laboratory/project in relation to objectives and effectively communicates to senior management; works to optimize laboratory performance based on metrics.
Personnel Supervision and Management
Oversees operational activities of staff working in the laboratory Provides guidance and expert advice to staff on technical issues, safety procedures and regulatory compliance matters within the laboratory.
Monitors operations to ensure compliance.
Provides personnel development and performance feedback
Ensures that new employees are appropriately trained/on-boarded and familiar with laboratory operational requirements; Supervises orientation and training of new project staff Ensures adequate staffing levels and support necessary for operation of the department
Scientific Operations and Management
Perform/support activities to ensure test method life cycle management (documentation, method suitability/trending, maintenance, etc.).
Support completion of analytical deliverables to meet project milestones.
Assist in the evaluation of new technologies/ improvements to support analytical expertise as required.
Reviews and evaluates data and formulates recommendations as needed. Works with internal and external partners in support of collaborative projects. Prepares key documents as required.
Financial Operations
Tracks/manages expenditures against assigned budgets. Advises management of significant budget deviations.
Assures that all laboratory financial operations comply with corporate requirements.
Reviews budget by integrating data from different projects, verifying that expenses have been correctly charged to different projects in compliance with requirements, making corrections as necessary
Regulatory/Quality Management
Ensures adherence to all applicable quality, corporate, safety, and regulatory requirements.
May serve as Subject matter Expert (SME) as required
Support departmental quality by ensuring adequate support for documentation, investigation, and closure of quality items including change controls, deviations, and CAPAs.
About You
Requirements:
PhD +4 years' experience, MS +6 years' experience, BS +9 years' experience in industry setting. Degrees in science related major preferred.
Clear communicator (written and verbal) - Written skills required to create clear and concise documents including procedures, deviation investigations, plans, test cases and reports. Verbal skills required to be able to act as a liaison between different groups/stakeholders, such as GCI and Maintenance/HSE.
Creative and abstract thinking - Required to develop and implement innovative, creative and efficient solutions to issues.
Ability to focus on deadlines and deliverables - Candidate must be goal driven to ensure project timelines are met, and to resolve issues to meet schedules when needed.
Functional/Technical Skills
Previous experience in research and /or laboratory setting.
Knowledge of supervisory principles and practices.
Excellent technical skills, analytical ability, judgment with a strong operational focus.
Demonstrated organizational and prioritization skills.
Excellent communications skills.
Excellent interpersonal, technical, scientific and communications skills (written/oral).
Advanced written and verbal skills.
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
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.
