We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.
We don't follow footsteps. We create the path.
The process development downstream team is seeking a highly motivated and innovative process scientist. The position will primarily a lab-based role, s/he is responsible for developing robust and scalable downstream manufacturing process to support early and late phase gene therapy products in Spark's innovative pipeline. The role will also be responsible for providing technical support to technology transfer, scale up, and internal/external manufacturing, as well as regulatory filings as needed.
60% Design and execute lab experiment to develop efficient, robust, scalable and cost-effective downstream purification process
25% Analyze and interprets process and analytical data to make sound decisions
Maintain accurate and complete lab notebooks. Authoring technical reports, data summaries, tech transfer reports.
Present results in internal meetings or external conferences.
15% Interact with internal and external partners, may represent functional area on cross functional teams
Support downstream process tech transfer, scale-up, clinical and commercial manufacturing as needed
Support regulatory filings
Leverage personal strength, knowledge and experience to mentor colleagues or intern students
Ph.D. in Chemical/Biochemical Engineering, Biological Sciences, or a related scientific discipline, or MS with 3+ years of relevant industry experience
In depth understanding and hand on experience in one or more of the following area is required: preparative chromatography, membrane filtration (NFF, TFF, viral filtration), membrane chromatography, continuous processing, process modeling
Experience with high throughput liquid handling and robotics as applied to downstream process development is preferred
Knowledge of analytical methods to support product and process characterization is preferred
Knowledge of statistical methods for DOE design and data analysis (eg JMP) is highly desirable
Experience with downstream process development of biological products, such as viral vectors, vaccine, recombinant proteins is preferred
Describe critical skill and abilities needed to successfully perform the job, which should be representative of the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Strong organizational skills and detailed documentation abilities is required.
Work independently in hands-on laboratory setting, self-motivated to learn and develop new techniques
Perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
Excellent writing and verbal communication skills is required.
Team work a must.
Must be comfortable in the fast-paced, multi-tasking biotech environment.