Manufacturing Science and Technology Downstream Scientist / Engineer

The Manufacturing Science and Technology (MS&T) Downstream Scientist will be responsible for execution of hands-on laboratory experiments related to downstream technologies as a basis for manufacturing platform development. The MS&T Lab group, a subset of the larger MS&T Team, will support ongoing manufacturing and product lifecycle projects for both drug substance (DS) and drug product (DP) specific activities including:

• Laboratory process experimentation supporting Manufacturing Operations
• Process characterization
• Small scale model development
• Raw material qualification and characterization
• Technology platform development and technology transfer driven by product lifecycle requirements

The incumbent will support multiple fast-paced non-clinical studies for advancing novel gene therapy programs across all Therapeutic Areas. The position requires strong scientific, interpersonal, and technical skills ina laboratory setting and a strong foundation in biochemistry/engineering principles.

Responsibilities

• Directly execute laboratory studies in support of ongoing manufacturing and technology development. The MS&T Downstream Scientist will be responsible for independently executing hands-on laboratory experiments to meet strict timelines.
• Responsible for experiments supporting process lifecycle studies including: process characterization, and continued process verification and process improvements
• Support the evaluation of downstream DS and DP technologies related to Purification activities, including column chromatography, filtration (UF/DF, TFF, viral), ultracentrifugation, harvest, recovery, buffer formulation, titration, product formulation and DP final fill operations.
• Authoring summary reports of laboratory experiments including technical writing, data analysis, and drawing conclusions from data.
• Author technical documents including but not limited to protocols, reports, and equipment standard operating procedures (SOPs).
• Develop appropriate scale down models and process modeling capability.
• Utilize sound judgment for troubleshooting technical problems and finding appropriate solutions, escalating as appropriate
• Collaborate with Technical Operations and Process Development.
• As requested by Process Development, evaluate and propose changes to process/technology to improve compliance or efficiency. Implement strategies relating to new process improvements and capital investments.
• Mentor junior members of downstream lab team as applicable.
• In Manufacturing support role, as needed, contribute to Root Cause Analysis and Risk Assessment Programs. As needed, support investigations for non-conformance by performing product impact assessments for facility, manufacturing, and raw material topics.
• As needed, be present at CMOs & CDMOs to monitor execution of production and studies, as well provide technical guidance as needed.

Manage individual performance to achieve business goals and objectives, as well as ongoing professional development.

• Manage performance: Know 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 work together to achieve mutual success and continuous improvement.
• Foster Spark’s Culture, Mission, Vision, and Values: Team members thrive in our Culture by living our truths, always in compliance with applicable laws and regulations. Understand “how” performance objectives are achieved is just as important as “what” is accomplished.

Education and Experience Requirements

• BS/MS/PhD in Life Science/Engineering or related field required.
• 2-6 years of experience in the Biotechnology or Pharmaceutical industry, industrial internships and/or co-ops
• Hands-on general laboratory experience, either in academic coursework, academic research, industrial internships, co-ops or full-time employment
• Knowledge of downstream bioprocessing unit operations and hands-on downstream purification experience required.
• Demonstrated successful contributions to project deliverables, timelines, and task prioritization.
• Experience with accelerated CMC development pathways a plus
• Knowledge of GXP requirements a plus

Key Skills, Abilities, and Competencies

• The position requires knowledge of downstream manufacturing/development of biopharmaceuticals or biologics. Experience with virus or vaccine manufacturing/development a plus.
• Demonstrated technical writing ability
• Champion all safety aspects in the laboratories. Stay current with all required lab safety and compliance trainings. Familiar with good laboratory practices and adherence to safety guidelines.
• Proven ability to productively collaborate cross functionally to deliver results. Acts to promote a productive and cooperative climate.
• Interpersonal communication skills are required. S/he will be responsible for the transfer of information to inter-departmental partners.
• Self-motivated, flexible, and willing to adapt to shifting priorities
• Ability to contribute to a culture of continuous improvement and operational excellence
• Experience with software such as Cytiva Unicorn, Repligen Krosflo a plus
• Experience with business software such as EDMS, SAP, Dynamics NAV, ReqLogic a plus.
• The successful candidate will perform data analysis and interpretation. Experience with data analytic tools such as SAS JMP, Umetrics SIMCA, Design Expert, Matlab, MathCAD a plus.

Complexity and Problem Solving

• Ability to prepare contingency plans and logically work through complex technical issues in a pressure filled atmosphere
• Ensure resolution to all technical laboratory issues.
• Erroneous decisions or failure to achieve results may have significant financial implications or cause delays in schedules.

Internal and External Contacts

Accountable to Technical Operations

Internal Contacts – Manufacturing Operations, QC, QA, Facilities, Supply Chain, Process and Analytical Development

External Contacts – Raw Material vendors, Equipment vendors, CMO / CDMO relationships

Other Job Requirements

Onsite laboratory work is routinely expected. Occasional off-hours work (nights & weekends) is intermittently expected. Limited offsite travel to CMOs and CDMOs may be required.

Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.

Nearest Major Market: Philadelphia

Join the Spark Team

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.