Scientist Ii, Upstream Process Development

1 week ago

Boston, United States Ensoma Full time

We are seeking a motivated and experienced Upstream Process Development Scientist to lead process development efforts for cutting edge adenoviral vector production processes, and implementing them in manufacturing.

You will join a team of scientists and engineers dedicated to bringing a bigger, bolder vision of genomic medicine into reality. As part of the Upstream Process Development team, you will leverage your experience with adherent and suspension cell culture viral vector production, drug substance manufacturing, and working with external partners to drive individual, team, and corporate goals. Join us and be part of a company moving novel gene therapies into the clinic, revolutionizing the reach and access of the curative power of genomic medicines for patients with serious diseases.

**Responsibilities**:

- Innovate process improvements through creative brainstorming and experiment execution
- Execute Experiments: Design experiments (DOE), in lab execution, statistical interpretation and communication of results
- Lead external development and manufacturing efforts at CDMO partners: development work, technical transfer, and manufacturing support
- Leverage strong written communication skills to document lab work using electronic lab notebooks, write reports, and support regulatory submissions
- Contribute to improving lab operations as company grows: manage equipment installations, author protocols, and train colleagues
- Maintain familiarity with current scientific literature and techniques in the field of virus production
- Mentor junior scientists and provide input on experiment plans and data analysis
- Other duties and responsibilities as assigned

**Qualifications**:
Required:

- A PhD in chemical engineering, biomedical engineering, biology, or a related biotechnology field with at least two years of post-graduate experience in biotechnology, pharmaceutical, or academic settings, some of which was spent in industry OR a Master’s Degree in a similar field with a commensurate amount of additional experience
- Experience developing processes with bioreactors and leading tech transfer/scale up into manufacturing: adherent and suspension cell culture, including experience using Sartorius systems (ambr15, ambr250, 1-10L benchtop bioreactors, and/or 50-2000L single use bioreactors)
- Strong DOE experience with demonstrated ability to make decisions based on statistical interpretation of data: experiment design, data analysis, process modeling, and simulation/process confirmation (JMP preferred)
- Familiarity with viral vector process development and manufacturing
- Strong troubleshooting skills, including overcoming difficult process challenges and manufacturing implementation.
- Experience leading upstream aspects of CMC development programs: process development, report writing, IND filing

Preferred:

- Experience with HEK293 adherent and suspension cell culture
- Knowledge of adherent and suspension cell line engineering, process development, media development, and process scale up
- Experience scaling processes from ambr or benchtop bioreactors to manufacturing scale single use bioreactors: 50L or larger

**About Ensoma**:
Ensoma is a place where you can ask the big questions. We look at gene therapy today and ask: What if we could eliminate the patient burden? What if we could treat diseases that affect millions? What if we could treat people anywhere around the world?

Ensoma was founded to answer these questions through our Engenious platform that can transform the hematopoietic (blood & immune) system with a single treatment. Our Engenious gene therapy platform is the first to precisely engineer any or all hematopoietic and immune cells with a one-time, off-the-shelf _in vivo_ treatment. Engenious therapies have an unmatched capacity to deliver all modern genetic modification tools and set a new standard for versatile cell programming and control across a range of complex diseases. We believe the future of medicine lies within us - and this bigger, bolder vision for gene therapy needs incredible people to make it a reality.

For our team, realizing this vision is personal. Founded and guided by leaders drawn from the top of the cell and gene therapy field, we feel an urgency and passion for our work driven by its potential global impact.

A meeting at Ensoma is a space where curiosity, trust, authenticity, problem-solving and professional development are celebrated. A career at Ensoma is an opportunity to be part of the team building the future of medicine.

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