(Associate) Director, Viral Downstream Process Development
Dispatch BioPhiladelphia, Pennsylvania, United States · Posted 1 month agoDescription
About us:
Our purpose at Dispatch is to help create a world where all cancer patients can be cured. We’re humbled by the opportunity to work together as a team on some of the most pressing medical challenges of our time.
To achieve our purpose, we are dedicated to engineering a universal treatment across solid tumors. We’re committed to the development of novel therapies, leveraging first-in-class technologies in viral vectors, universal targets, and novel cytokine biology. Our therapeutic approach has the potential to enable us to treat significant numbers of cancer patients and make a real and lasting impact on the world.
Our company was founded on pioneering work carried out in the laboratories of Dr. Carl June (University of Pennsylvania), Dr. Kole Roybal (University of California, San Francisco), Dr. Christopher Garcia (Stanford University) and Dr. Andy Minn (Memorial Sloan Kettering Cancer Center).
At our company, you would become one of our early team members— not only playing a role in meeting our ambitious mission but also building our thriving culture. We are determined to deliver with urgency to discover new solutions and we always stay dedicated to scientific rigor; we have an ownership mindset because each and every one of us is integral to our success. Collaboration is core for us because we believe that by bringing people together with diverse perspectives, we make a stronger whole. And, we show we care about our work and each other by sharing feedback - ultimately in service of our vision to empower people to continue forward with their lives – cancer free.
The role:
The (Associate) Director will serve as the downstream processing expert working closely with CDMOs to generate lentivirus and adenovirus products. Reporting into the Vice President of Process Development, this individual will also be responsible for building out the internal downstream purification capabilities within process development to support scale up and scale down.
Key responsibilities:
- Oversee planning and execution of tech transfers, development and scale up of viral products being manufactured at CDMOs
- Serve as the downstream subject matter expert on both internal and external (CDMO, equipment suppliers, etc.) teams
- Build out internal downstream capabilities by identifying/procuring scale down models for process development
- Design and execute studies to identify critical process parameters and optimize process setpoints across the clarification, Tangential Flow Filtration (TFF), chromatography and sterile filtration steps
- Responsibility for execution, data review, analysis, and maintaining accurate and detailed lab notebooks
- Author and review technical documents, including but not limited batch records, SOPs and development reports and process-specific sections of regulatory documents.
- Represent the company externally at meetings (professional associations, with regulatory bodies, etc.)
- Work cross-functionally with analytical development, research and development, program management to advance clinical programs
Required experience & skills:
- MS or Ph.D. in Chemical Engineering, Bioengineering or related discipline
- Minimum of 10 years of experience with downstream purification process development in the biopharma industry
- Experience directly managing a team
- Technical experience with downstream unit operations including clarification, TFF, chromatography, sterile filtration and formulation
- Experience with scale up and scale down of purification processes
- An understanding of cGMP and regulatory requirements for biopharmaceuticals
- Strong organizational & problem-solving skills, with the proven ability to collaborate in a dynamic team environment
- Strong scientific reasoning, problem-solving, and applied statistics skills, including the ability to break down complex problems into manageable hypotheses
- Proficiency in using Microsoft Word, Excel, Power Point and data analysis/presentation software such as JMP and/or GraphPad
- Excellent interpersonal, verbal and written communication skills.
- Excellent organizational and planning skills, strong work ethic and the desire to work in a flexible and fast-paced, entrepreneurial environment
Preferred experience & skills:
- Experience with Quality by Design (QbD) approach to drug development including risk assessments, Design of Experiments (DoE) and statistical methods
- Experience drafting CMC sections for INDs
- Experience with technology transfers to external manufacturing facilities
Our values:
Our values guide everything we do. While capabilities and skills are vital, understanding how a potential new colleague would embody our values is central to our hiring decisions.
Determined to deliver:
By working with focus and passion, we can provide patients with the solutions they need.
Own every outcome:
We can reach new heights when we stay centered on our shared success.
Collaboration at the core:
When we band together, our work is better.
Feedback is fundamental:
Constructive and authentic positive feedback may be difficult to master but it is vital to our success.
Working here:
- We offer a highly competitive compensation package with meaningful ownership through equity
- Excellent coverage for medical, vision, and dental
- 401(k) with generous contribution
- Life insurance
- Flexible PTO policy
- Additional substantial benefits
We are an equal opportunity employer.
We do not discriminate on the basis of race, religion, gender, sexual orientation, age, marital status, veteran status, disability status, national origin, or any characteristic protected under applicable law.
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