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Cell Culture Process Development Scientist - Upstream PD

Spark Therapeutics
Philadelphia, Pennsylvania. Hybrid and remote options available for select opportunities.
Salary not provided
Closing date
Apr 15, 2023

Job Details

The upstream cell culture process development group is seeking a highly motivated Cell Culture Process Development scientist. S/he will be a key member of the cell culture bioreactor group and will develop and implement processes to support process development, control and robustness efforts in Spark’s gene therapy drug substance modality. She/he will:

  • Performing experiments in the development, optimization, characterization, and scale-up of recombinant adeno-associated viral vector (rAAV) production processes in suspension cell culture systems, with a focus on stirred tank bioreactor production up to and > 200L.
  • Conducting rAAV production studies in shake flasks and stirred tank bioreactors from AMBR to commercial pilot scale.
  • Assisting in addressing production process challenges by applying cross-functional knowledge with an understanding of industry best operating procedures.
  • Analyzing and interpreting experimental results; suggesting changes or additional experiments to improve the robustness and/or reproducibility of the production process.
  • Participating in discussions regarding the troubleshooting of production processes and/or investigations; performing supporting studies as needed.
  • Contributing to the evaluation and implementation of new technology development.
  • Participating in Technology Transfer from process development to manufacturing sites; assisting in training manufacturing staff as needed.
  • Authoring and executing protocols, assembling data and drafting appropriate technical documentation, which may include, but is not limited to SOPs and Process Development Reports.
  • Maintaining an accurate laboratory notebook following ALCOA+ principles.
  • Participate on Pipeline and/or Technology Platform project teams as a contributing member.

The Process Development Scientist - Upstream position requires the following:

  • The successful candidate will be skilled in suspension cell culture and stirred tank bioreactor operation.
  • He/she should have hands on working experience in upstream process development, including familiarity and knowledge of production processes, capability for troubleshooting process and/or equipment issues, and ability to work/communicate effectively with fellow team members, as well as within project teams.

% of Time

Job Function and Description


Design and execute experiments, deliver results for studies in support of objectives. Troubleshoot any experiment issues that arise.


Author technical process development protocols and reports and any other relevant process documentation (e.g., Process Descriptions, PD Data Summaries, etc.)


Attend internal and external meetings, participate in training sessions, perform administrative duties. Prepare documents/presentations/materials for meetings.

Education and Experience Requirements

  • Ph.D. in a relevant scientific discipline (e.g., chemical engineering, biological engineering, molecular biology, virology, biochemistry, etc.) or a B.S./M.S. in a relevant scientific discipline with 3+ years of relevant scientific and/or technical experience in the Bioprocessing field.
  • Hands on experience in upstream process development with aseptic suspension cell culture methods in shake flasks and benchtop stirred tank bioreactors is essential.
  • Adept technical writing skills with experience authoring/reviewing technical documentation (protocols, reports, SOPs, etc.) is essential.
  • Experience in Technology Transfer of suspension cell culture stirred tank bioreactor production processes from Process Development to cGMP receiving entities (internal MFG, CDMO, CMO, etc.) is preferred.
  • Experience with development and optimization of feeding strategies in bioreactors is a plus.
  • Familiarity with statistical design/analysis software and digital proficiency is a plus.
  • Familiarity with AAV or viral vector production is preferred.
Key Skills, Abilities, and Competencies

  • Proven ability to work independently in a 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.
  • Self-motivated, fast learner and driven to innovate with problem solving mindset
  • Excellent written and verbal communication skills.

Complexity and Problem Solving

  • Demonstrate problem-solving skills when faced with technical issues; capable of working on more than one task and developing solutions for moderately complex problems. Discuss with supervisor and refer to policies/practices for guidance.
  • The Cell Culture Scientist is expected to work with the Upstream Process Development Team in designing and executing experiments, interpreting results, and performing any necessary troubleshooting.
  • Must be comfortable in a fast-paced environment and interact with multi-disciplinary Research, Process Development, and Tech Operations teams at Spark.
Internal and External Contacts

  • Fellow Upstream PD Team Members to discuss scientific and technical issues.
  • Cross-functional Team Members such as: R&D Operations, PD Downstream, PD Analytical, PSO, Technical Operations, Quality Assurance, Quality Control, Regulatory Affairs, Facilities, Materials Management, and Service Personnel/Vendors.
  • External Vendors for the evaluation of new technologies, instruments and/or materials.
  • External contact development and/or manufacturing organizations.
Other Job Requirements

  • Must be able to lift 25 pounds.
  • Due to the inherent nature of cell culture, some weekend work and/or work on holidays may be needed. On occasion, long work hours may be required depending upon the experiment schedule.
  • Handling large volumes of cell culture or related materials, such as tens of liters, may be required.
  • Some travel may be required for TT, training, and conference attendance.

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.

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.

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.

Learn more about Spark Therapeutics and view other openings.


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