Manufacturing Science and Technology Upstream Lead Engineer/Scientist

The Manufacturing Science and Technology (MST) group resides in Spark’s Technology Development and Operations organization as an arm of the Manufacturing department. MST’s key responsibilities are to support the development and manufacturing of gene therapies, starting with their transition into clinical manufacturing and continuing through the remainder 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. Scope and complexity of studies will vary greatly. Duration will span from single-day one-off experiments to year-long projects composed of multiple experimental sets, and can be categorized as follows:

• process scale up, support and trouble shooting
• process and material characterization
• process and method validation studies
• small-scale model qualification
• control strategy development
• investigation support to close deviations (non-conformance)
• technology development and technology transfer driven by product lifecycle requirements
• raw material qualification and characterization
• technology platform development and integration

Upstream Lead Engineer/Scientist Responsibilities

The MST Upstream Lead Engineer/Scientist will lead a lab-based team responsible for executing cell culture experiments. The incumbent will be accountable for managing projects and Upstream Lab personnel, as well as participating in experimental execution in a hands-on capacity. More specifically the candidate will:

• support the MST Lab Lead in developing upstream team goals and objectives and tracking metrics
• manage upstream lab day to day operations including prioritization decisions
• Supervise Upstream Lab staff, including development and tracking of individual goals and objectives and evaluate performance against metrics and adherence to Spark values on a routine basis
• be accountable for Upstream Lab staff Career Develop Plans (CDP) including designing individualized development plans and enabling their completion
• collaborate with partner organizations, for example manufacturing, to conceptualize MST Lab studies
• manage lab project responsibilities and assign to Upstream Lab staff, matching project complexity to staff capabilities and development goals
• evaluate all experimental designs for potential to deliver intended process and product knowledge
• analyze data and draft repots summarizing studies, as well as review and approve analyses and reports generated by junior staff
• serve as an Upstream SME across all MST activities across product lifecycles
• represent MST on various technical strategic and technical forums and provide progress reports to CMC Team members as appropriate.
• discover, evaluate and drive implementation of new technologies and methods of manufacturing
• collaborate with senior technical staff cross-functionally to develop and refine Upstream platform processes
• participate in authoring and reviewing relevant sections of regulatory dossiers as well as answering any upstream related questions stemming from these regulatory filings

Manage individual performance to achieve business goals and objectives, as well 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 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

• BS/MS/PhD in Life Science/Engineering or related field required
• Minimum 8 years of experience in the Biotechnology or Pharmaceutical industry
• Experience in biopharmaceutical based GMP manufacturing science and technology; direct experience in cell culture in development at bench-scale and with ambr250 required
• Proven track record of contributions to upstream manufacturing technology platform development, in a GLP/GMP Pilot Plant and/or development lab facility
• Demonstrated technical project management experience to develop project goals, deliverables, timelines, budget management and ongoing prioritization.
• Experience with accelerated CMC development pathways a plus
• Knowledge of GXP compliance
• Although previous direct supervision experience is not required, candidate must demonstrate prior experience mentoring junior employees, co-ops or interns

Key Skills, Abilities, and Competencies

• The position requires extensive knowledge and experience with cGMP upstream manufacturing of biopharmaceuticals or biologics and the life cycle management of these processes. Experience with virus or vaccine manufacturing a plus.
• Experience with advanced upstream analytics, such as Raman Spectroscopy and Capacitance probes is required
• Demonstrated ability to lead investigations, study execution, and produce high quality technical documentation.
• Proficiency in Statistical Design of Experiments (DOE) Design and Analysis is required.
• Experience with Multivariate Data Analysis (MVDA) approaches and tools (such as SIMCA) a plus.
• Advanced knowledge management, process and cost modeling experience a plus.
• Proven ability to productively collaborate cross functionally to deliver results. Acts to promote a productive and cooperative climate. Helps to promote team effectiveness by engaging in a trusting, supportive partnership with others. Encourages or facilitates a beneficial resolution of purpose. Resolve conflicts in a constructive manner that allows win/win solution.
• Demonstrated ability to prioritize and coordinate activities within and across work groups; able to anticipate priority differences and issues and resolves these before problems occur, exceeds desired results.
• Participates in the budget development process; effectively controls the controllable expenses (OT, Supplies, T&E) within the Upstream Lab Team.
• Develops stretch goals for Upstream Lab Team and uses effective motivation techniques to achieve them. Strong team diagnostic skill and strategy for team growth. Shapes site goals and policies. Able to effectively lead cross functional teams.
• Ability to motivate staff, foster a culture of continuous improvement and operational excellence.
• LEAN leadership experience beneficial.

Complexity and Problem Solving

• Efficiently complete true root cause analysis, corrective action plan development and execution, including effectiveness verification.
• Ability to prepare contingency plans and logically work through complex technical issues in a pressure filled atmosphere
• Ensure resolution to all organizational, technical and product lifecycle management 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, Process and Analytical Development

External Contacts – Raw Material Vendors, CDMO relationships (e.g. Pfizer, other Spark CDMOs)

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.