Senior Process Sciences Engineer | Philadelphia, PA

(MST) and Process Engineering Department resides in Spark’s Patient Supply Organization. This role reports into the MST arm of the department where the key MST group responsibilities are to support the development and manufacturing of gene therapies, starting with their transition into clinical manufacturing and continuing through the remainder of the product lifecycle.

This comprises of, but is not limited to, process fit evaluation, tech transfer, person-in-plant support, investigation of deviations, late-stage process development, data analysis, process validation and annual production reporting, all for both internal and external manufacturing. The MST Lab team carries out wet-lab

experimentation necessary to support the efforts described above for late-phase and commercial programs. Scope and complexity of studies vary greatly. Duration will span from single-day one-off experiments to year-long projects composed of multiple experimental sets.

The types of work include: process scale up, support and trouble shooting process and material characterization process validation studies small-scale model development and qualification control strategy development investigation support to close deviations (non-conformance) technology development and technology transfer (TT) driven by product lifecycle requirements raw material qualification and characterization process

technology development and integration Responsibilities Design and execute process studies.

Document results in laboratory notebooks, presentations and in technical documents Serve as an AAV drug substance manufacturing process subject matter expert (SME) as needed during various types of activities, such as manufacturing deviation investigations, risk backssments, facility design, equipment evaluations, and technology transfer Monitor and evaluate technologies related to efficient, robust and scalable bioprocess technologies Routinely interface with partner lines: Manufacturing, Process Development, Quality Assurance and Control and Supply Chain Author Standard Operating Procedures (SOPs) for laboratory equipment Assist Engineering, Facilities and Maintenance teams with the troubleshooting and maintenance of laboratory equipment.

Lead or support manufacturing deviation investigations As needed, be present at CMOs & CDMOs to monitor execution of manufacturing steps and studies, as well provide technical guidance as needed. Support authoring and preparation of content for regulatory documents, interactions, and inspections Support initiatives to streamline MS&T processes Manage individual performance to achieve business goals and objectives, as well as, ongoing professional development.

Manage performance: K now what is expected, what it takes to be successful, and self-monitor progress. Be accountable to achieve results while demonstrating the Spark Values. Periodically review individual objectives to ensure alignment to corporate and functional objectives, making adjustments if priorities have shifted. Commit to collaborate. Be a strong team player and business partner cross functionally. Understand the development goals, strengths and motivators of your colleagues and partner to achieve mutual success and continuous improvement as well as professional development.

Foster Spark’s Culture, Mission, Vision, and Values: Lead by example. Create an environment where team members thrive in our Culture by living our truths, always in compliance with applicable laws and regulations. Emphasize to employees that “how” they achieve performance objectives is just as important as “what” they accomplish. Education and Experience Requirements Required Experiences BS/MS/Ph D in Life Science/Engineering or related field required. Minimum 4 years of Biotechnology and/or medical experience Hands-on cell culture bioreactor and/or microbial fermentor operation Thorough understanding of upstream bioprocessing scientific and engineering principles Working knowledge of downstream bioprocessing scientific and engineering principles Experience in designing experiments Demonstrated technical project management experience to develop project goals, deliverables, timelines, budget management and ongoing prioritization.

Up to 20% travel Preferred Experiences Hands-on filtration (direct and tangential flow) and chromatography experience Experience in biomedical based GMP manufacturing science and technology; direct experience in upstream and/or downstream development or production environments.

Proven track record of contributions to manufacturing technology platform development, in a GLP/GMP Pilot Plant and/or development lab facility Experience with accelerated CMC development pathways a plus Knowledge of GXP compliance Spark takes into consideration a combination of candidate’s education, training, and experience as well as the position’s scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary for potential new employees. The base salary range for this position is currently from $95,800 to $143,600.

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