Bioanalytical Scientist
About the Company:
We are an innovative company dedicated to advancing science and improving patient outcomes. Our core values—Trust, Accountability, Perseverance, and Innovation—guide our daily operations and drive our commitment to making a meaningful impact on patients, their families, and the broader community.
The Role:
We are seeking a Scientist specializing in Bioanalytical Sciences to lead genomic analyses for biologics. The successful candidate will develop and validate bioanalytical methods, including molecular assays (e.g., qPCR, ddPCR, RT-PCR), LC-MS, and Ligand Binding Assays (LBA), to support our gene therapy pipeline. This role requires a blend of technical expertise and a willingness to explore novel technologies. Collaboration with various departments, including Research and Early Development, Quality, and Clinical Development, is essential, as is overseeing Contract Research Organizations to ensure compliance with regulatory standards.
Your Responsiblities:
- Develop, qualify, and validate robust bioanalytical methods according to Health Authority Guidance Documents using techniques such as qPCR, ddPCR, LBA, and LC-MS/MS to support the company’s pipeline.
- Foster innovation and evaluate new analytical techniques or technologies to improve operational efficiency.
- Assume accountability for scientific study conduct and ensure the integrity of all analytical development and validation activities.
- Oversee technology transfer between research organizations, in-house teams, and contract laboratories.
- Serve as the lead Scientist for the bioanalytical components of non-regulated, GLP, and GCP studies.
- Write and review study protocols, analytical procedures, and reports for regulatory submissions.
- Conduct technical reviews of analytical data, ensuring accurate data interpretation and reporting of results related to method development and validation.
- Provide scientific and technical input to study teams and other departments.
- Coordinate multiple projects, effectively managing timelines and priorities to meet departmental and organizational goals.
- Mentor and train new and less-experienced employees while developing training materials and schedules.
- Contribute to the writing and review of departmental Standard Operating Procedures (SOPs).
Your Background:
- PhD in a relevant scientific discipline with 4-7 years of industry or post-doctoral experience, or a Master’s degree in a relevant scientific discipline with 10+ years of experience.
- Strong understanding of polymerase chain reaction (PCR) techniques, including qPCR and dPCR, and proficiency with commercially available PCR machines and primer/probe design.
- Knowledge and hands-on experience with LC-MS methods is advantageous.
- Familiarity with bioanalytical FDA guidance documents and health authority expectations for bioanalytical assays.
- Ability to independently plan experiments while seeking feedback to align proposals with project needs.
- Strong capability to execute experiments efficiently to support scientific goals and project deliverables.
- Ability to interpret data, draw conclusions, and recommend subsequent actions.
- Strong communication skills, both oral and written, to convey information effectively in various formats (lab notebooks, presentations, reports).
- Prior industry experience is essential.
- Knowledge of gene therapy is a plus.
Apply Directly or Reach Out: will.manchester@albionryeassociates.com
