Full Job Description
This Jobot Job is hosted by: Marcus Brewster
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Salary: $125,000 - $200,000
A bit about us:
We are a clinical-stage biotechnology company focused on discovering and developing biologic therapies for life-threatening, drug-resistant infectious diseases, particularly those treated in hospital settings.
Why join us?
Competitive Base Salary + Bonus!
Extremely Competitive Benefits Package!
401K and PTO!
Accelerated Career Growth!
The Director leads the development, implementation and standardization of critical bioassays in support of early and late clinical development programs and is a contributing member/leader of project teams. This person will work in conjunction with the Head of Quality to develop and implement processes and standards to ensure that the conduct and reporting of laboratory testing is in line with Good Laboratory Principles (GLP).
Develop non-clinical and clinical assays that will be outsourced to CROs
In conjunction with the project teams, determine the overall assay strategy for development programs
Manage CRO and vendor activities including reagent generation, method development, transfer, validation and sample testing
Communicate results, progress and issues to project teams
Provide Project Management support for small scale projects and general tracking in support of laboratory activities that generate/provide data for regulatory submissions
Provide scientific guidance and training to junior staff
What you bring to the role:
Masters or PhD in Life Sciences field with 6-10+ years of experience in the biotech/pharmaceutical industry.
Demonstrated experience with bioanalytical and biomarker assay development to support clinical and non-clinical activities.
Hands-on experience developing molecular biology, cell biology, biochemistry and immunology methods
Knowledge of assay development and validation, and understanding GLP requirements and ICH guidelines desirable
Experience coordinating and managing CROs and vendors under tight timelines
Excellent organizational, planning, and multi-tasking skills
Strong knowledge in scientific information retrieval
Demonstrated success of working in cross-functional project teams
Knowledge of regulatory requirements and experience in dealing with regulatory authorities and experience conducting due diligence.
Strong interpersonal communication skills and ability to manage in a dynamic, ever-changing working environment.