Head of Manufacturing
We make platelets. We are perfecting methods to produce functional megakaryocytes by differentiation from human pluripotent stem cells, and have developed and patented a platelet bioreactor to efficiently generate donor-independent platelets from these megakaryocytes. We are now advancing our own cGMP‐compliant human induced pluripotent stem cell line and are scaling platelet production for human clinical trials (2‐3 year pre‐clinical study). We are currently seeking a scientist with proven bioprocess engineering skills within industry to lead the scale-up development efforts for production of megakaryocytes from iPSCs.
Duties and Responsibilities
Because we are a startup, the position calls for duties that are broad and variable, with significant opportunity for advancement. Specifically, you will be responsible for:
- Lead, design, and execute the scale up of R&D based hiPSC expansion and differentiation from 2D culture into large cGMP-compliant 3D manufacturing for clinical trials and commercial purposes.
- Interact and work closely with CRO supporting our process development and scalable process.
- Identify and implement short and long terms goals, contingency plans that align with milestones and priorities, industry standards, technical and business process metrics to ensure operations are performing effectively.
- Coordinate and interface with colleagues from other groups involved in the research process.
- Active involvement in technology transfer via written process transmittals, and by providing troubleshooting, process understanding, and on-site support to manufacturing production.
- Generate, manage, analyze, and maintain critical data in a highly organized manner.
- Author, review, coordinate, and track study protocols and development reports pertaining to process improvements, qualifications, validation, and process implementation for documentation purposes.
- Represent the company in a professional manner at speaking engagements, conferences, partner meetings, Board discussions (as needed) and regulatory meetings.
- Supervision, training, and mentoring of engineering and scientific staff in the future.
- Some local, regional, and/or international travel may be expected (<25%).
- Authorized to work in the U.S.
- PhD/MS, with a minimum of 5-7 years relevant industry experience.
- Has demonstrated the ability to organize external resources, including CROs, to maximize quality and efficiency.
- Experience with mammalian cell culture, specifically human induced pluripotent stem cells and their differentiation (experience with hematopoietic differentiation a plus), and associated cellular analysis to verify culture expansion and differentiation (i.e., microscopy, flow cytometry, gene expression, etc).
- Experience with fed-batch and perfusion-based bioreactor processes including optimizing, feeding strategies, and evaluating different cell culture media and feed formulations, as well as the scale up of these process from R&D to cGMP- manufacturing.
- Excellent written and verbal communication skills to deliver technical summaries of data and high-level explanation to support strategic decisions.
- Strong interpersonal skills, with ability to influence, negotiate and work well with internal staff and external collaborators.
- Ability to multi‐task efficiently and work under pressure with precision.
- Experience with training and supervising staff at various levels.
- Willingness to go above and beyond job requirements when necessary.
Preferred Qualification and Additional Skills
- PhD, with 10+ years relevant industry experience, or M.S. with 15+ years relevant industry experience.
- Experience with statistical design and analysis software (i.e. GraphPad Prism).
- Familiarity with manufacturing/process-associated computer programming languages, relational database interface, networking interactions, and software installation/troubleshooting.
- Medical, Dental, Vision Insurance
- Retirement Planning (401k)
- Unlimited vacation/sick days
- Parental Leave
- Commuter Benefits and much more!