Address
Form of work
About Us
About the Role
The Senior Bioanalytical Scientist will be responsible for executing bioanalytical and biomarker strategies and technologies to support preclinical and clinical studies of novel drug candidates.
You will report to the Senior Director, Bioanalytical Sciences and provide technology development, scientific and technical expertise in protein biologics assay development, optimization, and qualification/validation. You will be responsible for driving nonclinical and clinical drug development projects, directly impacting our pipeline. Day to day you will work with and build strong collaborations with external contract research organizations (CROs.), serve as a key member of the project team, collaborating with other functional areas to ensure the timely and successful development of drug candidates. You must have experience measuring large molecules in biological matrices to be successful in this role.
This is a highly visible role and an exciting opportunity to join a small, clinical-stage biotech company in growth mode. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients' lives. We are open to you working remotely.
Key Responsibilities
- Assist in the conception, implementation, management, and analysis of a diverse range of bioanalytical and biological testing (including measurement of drug concentrations and anti-drug antibodies, as well as biomarkers) for novel, complex biotherapeutic drug candidates in support of nonclinical and clinical development.
- Ensure thorough CRO evaluation, selection, and management, including vendor audits, personnel training, and troubleshooting/investigations as needed for transfer of bioanalytical methods.
- Coordinate and manage network of CROs for study development and execution.
- Support drafting of regulatory filings in collaboration with Program Leadership and Regulatory.
- Collaborate with other functional areas to assist timely and successful development of drug candidates.
- Assist in management of resources and budgets to support the development of PK/PD assays and the interpretation and reporting of PK/PD data.
- Ensure compliance with all relevant regulations, guidelines, and standards for bioanalytical assays.
- Communicate PK/PD data to project teams, senior management, and external stakeholders in a clear and concise manner.
- Assist in evaluating new technologies and approaches to improve PK/PD assay development and execution.
Experience
- PhD in biochemistry, immunology, pharmacology, or other relevant scientific discipline and 5+ years of industry experience
- Demonstrated experience in bioanalytical assay development and execution in the pharmaceutical / biotechnology industry, with a focus on PK, PD, ADA, and biomarker assay development. Experience in complement, cell, and analytical chemistry-based assays development a plus.
- Experience with global outsourcing/CRO management
- Experience with GxP compliance requirements and FDA regulatory guidelines as applicable in support of biologics drug development programs.
- Working knowledge of quality systems and regulatory requirements with experience in preparing and defending regulatory filings.
- Experience with writing/reviewing successful regulatory submissions.
- Strong project management skills
- Excellent communication, writing and presentation skills, with the ability to communicate data clearly and concisely to project teams
- Demonstrated ability to work effectively in a fast-paced, collaborative, and dynamic environment.
