Associate Director, Virology Laboratory Technical Support

Job Description

Our Laboratory Technical Support ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed, in alignment with our high standards of quality and all regulatory requirements.  Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers, we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

We are seeking an Associate Director that can drive strategic priorities through technical support in our Quality Control Laboratories.  This is a second shift position, focused on supporting Laboratory Operations during core second shift hours (4PM – 12AM). 

Key Responsibilities

• Providing quality and technical support to Laboratory Operations, in their execution of biological assays for Quality Control testing and direct on-the-floor support.

• Advocating for safety and environmental stewardship.

• Proactively partnering with Laboratory Quality Assurance to ensure compliance in the laboratory in accordance with cGMPs, and GLPs, international regulations and our Company guidelines, policies and procedures.

• Conducting investigations aimed to prevent deviation recurrence, including establishing the root cause, identifying corrective/preventative actions, identifying event scope, and conducting product impact assessment.  Where applicable, completing investigational test protocols to determine root cause, product impact, event scope, etc. 

• Guiding key projects that require collaboration across functional areas to drive robust processes and continuous improvement.  Continuous improvement includes proactive process/assay improvements, investigation Corrective/Preventative Actions (CAPAs), or value capture projects that seek to improve assay robustness, reduce cost, lower cycle times, or improve schedule adherence.

• Actively using and championing the use of Lean Six Sigma (LSS) and our Company's Production System (MPS) tools, both in problem solving and day-to-day operational activities.

• Authoring and updating technical documents necessary for investigations, assay design/definition, engineering studies, change control and validation.

• Independently manage all aspects of assigned projects and run the business activities including decision making, leading laboratory investigations, stakeholder management, issue identification and resolution, understanding of capacity and demand, participating, and driving the tier process.

Education

• Bachelor of Science (BS) Degree in life science, chemistry, biochemistry, science discipline or engineering with eight (8) years of experience in a GMP manufacturing environment, people management, pharmaceutical/biological quality, operational, technical, or regulatory function. OR

• Master of Science (MS) Degree in life science, chemistry, biochemistry, science discipline or engineering with six (6) years of experience in GMP manufacturing environment, people management, pharmaceutical/biological quality, operational, technical, or regulatory function.  OR

• PhD in life science, chemistry, biochemistry, science discipline or engineering with three (3) years of experience in GMP manufacturing environment, people management, pharmaceutical/biological quality, operational, technical, or regulatory function.

Required Experience and Skills

• Analytical aptitude, critical thinking skills and ability to apply key concepts.

• Speaks with courage and candor.

• Strong written and verbal communication skills.

• Ability to manage multiple projects/tasks simultaneously.

• Demonstrated collaboration skills including flexibility, inclusive behaviors, and the ability to work in a team environment.

• In-depth working knowledge and application of GMPs/GLPs.

Preferred Experience and Skills:

• Project management, change execution management and team leadership experience.

• Demonstrated ability to develop and implement innovative solutions to challenges.

• Demonstrated facilitative leadership skills and able to lead teams to deliver results.

• Progressive and demonstrated decision-making responsibility.

NOTICE FOR INTERNAL APPLICANTS

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