Associate Director, Biosafety and Laboratory
2 weeks ago
**The Role**:
The Senior Biosafety Officer ensure of the development of team members competences and compliance to Lab safety policies and risk assessments. They will also lead in the health and safety compliance assessment of new platforms to support Moderna’s portfolio needs, and presentation of key performance indicators to teams/senior leadership. The position reports to the Director of the Clinical Biomarker Laboratory.
**Here’s What You’ll Do**:
Lead the Laboratory commissioning plan
Establish, maintain, and continuously improve on the biosafety program
Identify and implement comprehensive policies and procedures to support safety policy in relation with the BSL-2 and BSL-3 activities
Identify and document the functional requirements and expectations for the BSL-2 and BSL-3 Laboratory activities
Lead communication with groups at Moderna on the activities of BSL-3 Laboratory, actively participate in the Biosafety committee from Moderna and Harwell-site
Implement
A biosafety manual, access plan to the Laboratory
Personnel management and training
Safe work practices (Policies, Risk assessments and SOPs)
Waste management program with on-site stakeholder
Emergency response (procedure, drills, and internal audits).
Records and documentation
Foster a strong biosafety culture critical to the success of the biosafety program
Identified the necessary resources to support biosafety within the organization and the Clinical Laboratory specifically
Stay aware of the institutional risks related to hazardous biological agents and establish recurrent risks assessment
Promote and monitor compliance with legislative and regulatory requirements
Communicate with personnel at all levels of the organization about biosafety
Provides guidance to team to ensure that appropriate risk control strategies are implemented
Lead the development Laboratory specific Code of Practices.
Influences logístical strategy and internal resources to achieve safety department goals
Communicates with external stakeholders to anticipate on needs, and coordinates resource allocations to achieve team and project goals
Monitor schedule, timeline of testing across the BSL-2 and BSL-3 Laboratories with lead from the Lab Manager
Incorporates risk mitigation within projects and team leadership
Responsible for upholding all safety standards, discipline guidelines and regulatory compliance requirements to SOPs
Participate in audits
Ensure technical staff compliance to Laboratory SOPs, Risk Assessments, and policy,
**Here’s What You’ll Bring to the Table**:
Minimum of 8years of relevant experience required in BSL-3 laboratory environment
Masters/ Bachelor within a drug discovery experience at pharmaceutical, biotech or CRO is required. PhD is preferred.
Previous experience in working in CAP/ CLIA, GLP/ GcLP regulated laboratory highly preferred
Minimum 5 years of resource management experience
Extensive knowledge in clinical sciences and Technology in drug development
Previous experience in site audit, communication with regulatory agencies to discuss policies
Attention to detail, organizational ability, clinical judgement and good communication skills
High proficiency in MS PowerPoint and MS Project, excellent writing skills, organizational skills, and attention to detail
Excellent interpersonal and collaborative skills, and the ability to work independently and effectively in a highly dynamic environment
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
Educational resources
Savings and investments
Location-specific perks and extras
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have c
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