About the position
The Sr Scientist/Technical Lead Analytical Development will be part of the Process Development group, reporting to the Director of Process Development. He/She focuses on defining and managing the execution of the analytical development strategies and activities across the program/project lifecycle supporting process development and characterization. The Sr Scientist owns the analytical development assay lifecycle both from a technical and planning standpoint. Responsibilities will include scientific review and oversight of assay design, development, qualification, troubleshooting, and transfer as well as product characterization. The Sr Scientist will also be responsible for ensuring oversight of the analytical project timelines, and alignment across different teams and contributors to the analytical development efforts. The Sr Scientist is also responsible for management, training, and mentorship of junior Scientists and Associates within the Analytical Development team.
Responsibilities
- Developing, qualifying and transfer of client/product-specific assays to be used for in-process, release testing, and process characterization
- Providing analytical support to Upstream and Downstream process development team activities by ensuring consistent and timely execution of standardized platform product characterization assays, including data review, storage and trending
- Facilitating integration of new products into Genezen analytical platforms, to ensure timely progress of transfers and timelines
- AD team leadership including training, development and mentoring
- Owns the development lifecycle (method development, qualification, transfer), planning and timelines for multiple projects
- Responsible for analytical strategy and timeline definition and monitoring in line with overall project timelines and functional team input
- Oversees the project from an analytical standpoint as core member of the project team, and has key interactions with Upstream & Downstream process development, supply chain, and external consultants and vendors
- Communicates and aligns with internal and external stakeholders’ activities relevant to specific projects planning and progression
- Prepare data overviews and reports, including interpretation of results. Proposes next steps in experimental design including rational and timelines
- Presents project updates, progress and results to internal and external stakeholders
- Drafts or reviews laboratory and technical documentation such as SOPs, protocols, reports, position papers and memos
- Assist team members with their planning and coordination of activities
- Ensure all laboratory activities are performed according to applicable procedures to ensure a safe working environment and high data quality
- Provide improvement suggestions and enforce improvement implementation
Requirements
- MSc with 10+ years of industrial experience in a Life Sciences related field (biochemistry, molecular biology, biotechnology)
- PhD with 6+ years of industrial experience in a Life Sciences related field (biochemistry, molecular biology, biotechnology)
- Broad knowledge of the pharmaceutical industry, including in depth operating knowledge of functions and assays relevant to viral vector therapeutic analytical within drug development processes
- Demonstrated experience in project management skills and leadership experience, including setting timelines, alignment and helping others meet timelines
- Thorough scientific knowledge and hands-on experience with cell-based assays and bioassays, specifically in vitro potency assays
- Thorough scientific knowledge and hands on experience with relevant molecular biology techniques (e.g. qPCR & dPCR, DNA electrophoresis)
- Thorough scientific knowledge and hands on experience with biochemical analyses (e.g. protein electrophoresis, western blotting, ELISA)
- Thorough scientific knowledge in the process of assay design, assay development and trouble shooting
- Experience in viral vaccines or gene therapy
Nice-to-haves
- Prior managerial experience
Benefits
- Paid vacation days, amount based on tenure
- Paid sick time
- 10 observed holidays + 2 floating holiday + 1 volunteer day
- 401(k) plan with company match up to 6% of salary, vested immediately
- Share Appreciation Rights
- Choice of several healthcare plans
- FSA and HSA programs
- Dental & vision care
- Employer-paid basic term life/personal accident insurance
- Voluntary disability, universal life/personal accident insurance
- Accidental Death & Dismemberment (AD&D) Insurance
