Scientific Director- Upstream Process Development

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 unlock the power of gene therapy to accelerate healthcare transformation. 

We don’t follow footsteps. We create the path.

The Upstream process development group is seeking a highly motivated and innovative cell culture process expert. S/he will be responsible for scientific innovation to significantly improve Spark’s current AAV upstream production platform, with improved productivity, product quality and reduced cost. S/he will provide scientific guidance to the upstream process development team to develop robust and scalable cell culture processes in support of Spark’s gene therapy clinical pipeline. The incumbent will also work closely with vector engineering, cell line development, high-throughput automation, upstream and downstream technology group to develop new technology, processes and workflow to improve overall process development efficiency, and further our understanding and control of product quality.

He/she will be responsible to:

• Matrix lead and provide guidance on efforts in platform improvement to support growth and production of rAAV via triple transfection and/or use of a packaging and/or producer cell line.
• Provide technical leadership in upstream process design, optimization, characterization, and tech transfer, apply Quality by Design, risk assessment / prioritization to balance speed to clinic and product quality/yield/economic considerations to guide phase appropriate process development.
• Analyze and interpret process and analytical data and understand the process implications to help drive decision making on projects
• Provide scientific input on technical reports, data summaries, tech transfer reports and technical presentations.
• Provide technical support for trouble shooting, investigating technical problems in both lab scale and manufacturing scale.
• Represent Process Development group on cross-functional CMC teams, working proactively and collaboratively with other functional areas including R&D, Analytical Development, MS&T, Regulatory, Quality, internal manufacturing, external Manufacturing & CDMO group and Project Management.
• Drive new technology initiatives, establishing internal and external collaborations, and directing the necessary experiments for evaluation and implementation
• Drive scientific agenda within upstream group and develop talent.
• Facilitate mitigation and / or escalation of risks identified throughout the product lifecycle as appropriate
• Contribute to scientific / technical decision making on programs / projects
• Contribute to technical due diligence evaluations of business development opportunities
• Model the company’s values & culture in accordance with established policies

The position requires the following:

• The successful candidate will have deep knowledge of AAV biology and cell culture development, and familiar with cutting edge techniques.
• He/she should have extensive experience in cell line development, media and feed development, suspension cell culture, and capability for troubleshooting process and/or equipment issues. 
• He/she should have experience in mentoring and providing technical leadership to scientists and associates in cell culture and media development related activities in either matrix or direct management settings. 

Responsibilities

20% of time - Actively participates as a member of the Drug Substance Leadership team.  Help develop upstream technology road map. Responsible for providing scientific guidance to process and technology development workstreams in Cell Culture Team in alignment with Corporate Objectives.

40% of time- Responsible for leading key technology projects in upstream process development, including prioritize efforts in resource efficient way, perform experimental design and review, experiment execution, data analysis and summary. Drive implementation of platform improvement in pipeline projects.

20% of time- Author and critically review technical reports, protocols, technology transfer documents, and CMC sections of regulatory filings

20% of time- Attend internal and external meetings, communicate and present study plans and results, provide regular updates, and perform administrative duties as needed.

Requirements

• Ph.D. in Chemical/Biochemical engineering, Biochemistry, Virology, Cell Biology, Molecular Biology or a related scientific discipline with greater than 10 years of upstream process and media development experience in the biopharmaceutical industry.
• B.S./M.S. in Biology, Virology, Cell Biology, Molecular Biology, Biochemistry, Chemical Engineering or a related discipline with greater than >15 years of relevant experience
• Demonstrated accomplishments in advancing upstream biomanufacturing technology
• In depth knowledge of cell culture process fundamentals and practical experience in all upstream unit operations including harvest
• Versed in biologics CMC regulatory requirements and cGMPs
• Experience with process scale up, tech transfer, process characterization, PPQ and regulatory filing
• Effective matrix leadership experience of technical teams/programs
• Experience with gene therapy product is a plus
• Knowledge on microbial production processes is a plus

Competencies

• Applies QbD principles and scientific knowledge to the development of upstream manufacturing processes that are robust, reproducible, and scalable.

• Expertise in developing media and feeds for mammalian cell culture processes.
• Familiar with PAT and its applications in process development and manufacturing process monitoring/ control.
• Self-motivated, take initiatives and result oriented.
• Strong process data management and statistical experimental design and data analysis skills.
• Needs to be comfortable in a fast-paced environment and be able to collaborate with multi-disciplinary research teams at Spark.
• Ability to develop solutions to a variety of complex problems
• Excellent verbal and written communication skills  
• Be able to matrix lead scientific effort of significant impact

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 $162,560-$243,840.

Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.