Product Development Lead Scientist
KaloCyte, a pre-clinical stage biotech startup, is seeking a Product Development Lead Scientist with experience in the general areas of circulatory physiology, vascular biology and/or oxygen delivery to execute, oversee, implement and refine the development program for ErythroMer, a bio-inspired artificial red blood cell substitute. As the design and manufacturing of ErythroMer is optimized, the individual will have the opportunity to contribute to KaloCyte’s intellectual property portfolio.
Overall, the purpose of this position is to execute and oversee the technical development plan of KaloCyte’s ErythroMer, a bio-inspired artificial red blood cell substitute. The candidate will work closely with the CEO, CSO and CTO to coordinate and align activities and communication across company functions including technical, scientific, operations and business development and with external partners (academic partners, CROs, CDMOs, etc.).
This individual must have the commitment and strong desire to make impactful scientific and technical contributions within the blood substitute research field and ability to work in a highly collaborative, early development environment.
Essential Duties and Responsibilities
- Process development and infrastructure:
- Write and/or lead development of SOPs for R&D and related activities.
- Under the CSO’s leadership, coordinate the development and lead the implementation of technical development timelines and action plans.
- Manage R&D staff including review of lab notebook(s) to ensure alignment with SOPs.
- Employ QbD, a systematic approach to product design and development, to achieve meaningful product quality specifications, increase process capability and reduce product variability and defects by enhancing product and process design, understanding, and control.
- Technical Development:
- Under the CSO’s and CTO’s oversight, coordinate R&D and align focus across all elements of EM technical development goals with team and external partners.
- Execute in-vivo and ex-vivo experiments directly and/or by coordinating workflow and managing communication with university research collaborators. Develop and implement operations/logistics plans with clearly defined roles and responsibilities.
- Prioritize experiments and testing to meet needs for product development (IND, etc.) in alignment with grant obligations.
- Develop and utilize an inventory planning and management system for key materials, supplies and equipment maintenance to ensure availability for planned experiments.
- With the CSO, build experimental plans to capture data to meet product development targets identified in the QTPP and TPP.
- Write and submit grant proposals aligned with product development strategy.
- Perform and/or supervise all technical duties assigned to company under grants and contracts.
- Serve as Principal Investigator for grants and subawards from other institutions, as appropriate.
- Ensure grant obligations are met and reports are submitted on time.
- Oversee planning and implementation of budgets for relevant grant awards and subawards, ensuring adherence to grant budgets.
- In alignment with CSO, conduct periodic literature review of relevant work and apply learnings to development plans.
- Support CSO in development and execution of publication strategy.
- Represent company at scientific and business conferences.
To perform the job successfully, an individual should demonstrate the following competencies:
Critical Thinking - Ability to look at situations from multiple perspectives. Breaks problems into component parts. Considers and organizes parts in a systematic way. Creates solutions to problems using novel methods and processes. Looks for underlying causes or thinks through the consequences of different courses of action.
Planning/Organizing - Prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules other people and their tasks; develops realistic action plans.
Communication - Expresses ideas and thoughts verbally; expresses ideas and thoughts in written form; exhibits good listening and comprehension; keeps others adequately informed; selects and uses appropriate communication methods.
Education and/or Experience
- PhD preferred with emphasis in bioengineering or biology/physiology (ideally, in areas of circulatory physiology, vascular biology, oxygen delivery, blood/microcirculatory biomechanics, or related disciplines).
- Hands on experience in biotech or pharmaceutical industry with experience in drug or biologic development is preferred.
Strong proficiency with common office productivity systems including Adobe products, Microsoft Office (Word, Excel, PowerPoint, Outlook), and video conferencing (GoToMeeting, Zoom, etc.).
Salary is negotiable and commensurate with experience and accomplishments.
We value our employees’ time and efforts. Our commitment to your success is enhanced by our competitive compensation and benefits package including medical/dental insurance, 401K, 22 days of paid time off plus 6 sick days and 11 holidays.