Scientist/Sr. Scientist - Upstream PD: Process Analytical Technology (PAT) Development

The upstream cell culture process development group is seeking a highly motivated cell culture PD process analytical technology scientist. She/he will be a key member of the upstream PD group and will develop and implement process analytical tools to support process control and robustness efforts in Spark’s gene therapy drug substance modality. She/he will:

• Lead and execute experiments in the development, optimization, and scale-up of process analytical technologies in recombinant adeno-associated viral vector (rAAV) production processes in suspension cell culture systems.
• Collaborate with process development team to identify improvement opportunities for process control and robustness
• Investigate, develop, and deploy new PAT tools to improve process understanding and enhance process control strategies
• Analyze complex process data sets utilizing data science techniques to identify areas of process improvement or optimization
• Review and author protocols and technical reports
• Train less experienced team members in PAT and modelling tools
• Lead and support process development efforts from experimental design through execution
• Author and review CMC (Chemistry Manufacturing Control) sections to ensure high quality content for regulatory submissions.
• Participate in Technology Transfer from process development to manufacturing sites; assisting in training manufacturing staff as needed.
• Represent the Upstream 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.

The Process Development Scientist - Upstream position requires the following:

• The successful candidate will be skilled in fermentation, cell culture/engineering principles, statistics, multi-variate data analysis, process analytical technologies, and process development.
• She/he should have hands on experience in upstream process development, including familiarity and knowledge of fermentation, cell culture, gene delivery, and PAT capabilities for troubleshooting experiment and/or equipment issues, and ability to work/communicate effectively with fellow team members, as well as with project teams.

Responsibilities

% of Time

Job Function and Description

50%
Design and execute experiments, deliver results for the various development projects. Troubleshoot any experiment issues that arise.

20%
Author technical process development reports and any other relevant process documentation (e.g., SOPs, Process Descriptions, etc.)

20%
Design Experiment, author protocols and reports. Assemble experimental data and prepare data summaries.

10%
Attend internal and external meetings, participate in training sessions, perform administrative duties. Prepare documents/presentations/materials for meetings, conferences and/or publications.
Education and Experience Requirements

• Typically, has a Ph.D. in a relevant scientific discipline (e.g., pharmaceutical sciences, chemical engineering, biological engineering, molecular biology, virology, biochemistry, etc.) with 0-3 years or a B.S./M.S. in a relevant scientific discipline with 5-8 years of relevant scientific and/or technical experience in the life sciences/Biotech field or a B.S./M.S. with 4-6 years of direct experience with PAT development.
• Knowledge of process modelling, simulation principles, PAT and statistical tools with ability to solve complex problems
• Adept technical writing skills with experience authoring/reviewing technical documentation (protocols, reports, SOPs, etc.)
• Ability to develop solutions to a variety of complex problems
• Demonstrated ability in PAT development and validation using chemometric techniques, hands-on experience with various analytical spectroscopy is a plus
• Familiarity with gene delivery, rAAV production is a plus.

Key Skills, Abilities, and Competencies

• Proven ability to work independently in 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.
• Knowledgeable in Design of Experiments (DOE). Applying Quality by Design, risk assessment / prioritization to PAT development.
• Strong process data management and statistical analysis skills
• Good knowledge of qualitative and quantitative PAT model building approaches
• 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.
• Must be comfortable in the fast-paced, biotech start-up environment and interact with multi-disciplinary Research, PD, and Tech Operations teams at Spark.
• Exercise judgment within defined procedures and practices to determine appropriate action.

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.
• Although infrequent, some travel 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.

Learn more about Spark Therapeutics and view other openings.