Manager, CRO Oversight and Reagent Development
Sana Biotechnology is looking to expand our team with hard-working individuals who believe in the potential of cells as engineered medicines, have the vision to do creative things, and the determination to execute upon that vision. As a member of the Development Sciences, Bioanalytical group, you will work within a highly dynamic and cross-functional environment on projects of diverse scope and across multiple therapeutic areas. To accelerate the development of transformative medicines, we seek a candidate to build Sana's bioanalytical vendor engagement capabilities, including bioanalytical Contract Research Organizations (CRO) and reagent development oversight capabilities in support of regulated non-clinical and clinical studies and research programs. In this role, colleague will provide scientific and operational support for bioanalytical and reagent generation activities conducted at CROs aiming to advance various gene and cell therapy drug candidates. The successful candidate will have demonstrated technical proficiency, solid understanding of the GLPs, exhibit scientific rigor and independent thought as well as the ability to thrive in a team-oriented environment.
DUTIES AND RESPONSIBILITIES
Uses professional concepts in accordance with company objectives to solve problems in creative and effective ways.
- Provide scientific and operational oversight of bioanalytical activities conducted at Contract Research Organizations (CROs), independently and in collaboration with a representative of the Dev Sci Bioanalytical group.
- Provide scientific support to CRO efforts in design, development, and implementation of ligand binding, molecular, flow and other platform assays to determine analyte concentration, detect presence of immune response to drug product in a regulated (GLP, GCLP) environment
- Provide scientific and operational oversight for reagent generation activities conducted at CROs, independently and in collaboration with a representative of the Dev Sci Bioanalytical group
- Some laboratory-based activities can be required
- Work under a supervision of a Senior Scientist or higher with high degree of independence
- Work with Other members of the Dev Sci Bioanalytical group to ensure scientific rigor of analytical methods implemented and applied at CROs
- Interface with CROs to ensure on time delivery of required milestones
- Proactively communicate with the CRO to ensure transparence and adherence to the timelines, availability of required contracts, quotes, purchase orders, provide CRO with critical material, obtain and archive needed documentation, work with CRO to reconcile any scientific or operational concerns, manage standing review meetings, arrange vendor visits as appropriate
- Facilitate with the review of GLP and GCLP compliance status at CROs
- Comply with company policies
Master's degree or Bachelor's degree with 7-10+ years of experience in industry setting, hands on GLP/GCLP experience, proven proficiency performing independent research.
- Hands on experience with development of Bioanalytical methods in support of Biotherapeutic drug candidates. Experience with gene and cell therapies is a plus
- Hands-on experience working in regulated (GLP / GCLP) environment
- Experience managing CRO activities is a plus
- Excellent communication and presentation skills are required
- Industry experience with a focus on biotherapeutics. Experience with gene and cell drug candidates
- Excellent documentation skills
- Excellent communication skills
- Ability to clearly and concisely state the goals and deliver information
- Ability to work tight timelines on multiple properties
- Attention to detail and data quality
- CRO oversight experience
- Working with reagent vendor experience