The Sr. Scientist - Upstream Process Development is a key member of the Upstream PD Group. She/he will:
- Execute upstream process designs, 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
- Develop and execute strategies to optimize efficacy and toxicity of non-viral gene delivery approaches.
- Synthesize, characterize, and evaluate novel formulations for nucleic acid delivery.
- Lead and execute experiments in the development, optimization, and scale-up of recombinant adeno-associated viral vector (rAAV) production processes in suspension cell culture systems, with a focus on shaker flask and stirred tank bioreactor production at bench and pilot scales.
- Author and review CMC (Chemistry Manufacturing Control) sections to ensure high quality content for regulatory submissions.
- 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.
- Support and drive new technology initiatives; implement to improve upstream efficiency
- Troubleshoot of bench and pilot scale production processes and/or investigations; performing support studies as needed.
- Participate in Technology Transfer from process development to manufacturing sites; assisting in training manufacturing staff as needed.
- Author protocols and process development reports
The Process Development Scientist - Upstream position requires the following:
- The successful candidate will be skilled in cell culture/engineering principles, with experiences in formulation science as a plus.
- She/he should have hands on experience in upstream process development, including familiarity and knowledge of formulation and gene delivery, capability for troubleshooting experiment and/or equipment issues, and ability to work/communicate effectively with fellow team members, as well as with project teams.
% of Time
Job Function and Description
Design and execute experiments, deliver results for the various development projects. Troubleshoot any experiment issues that arise.
Author technical process development reports and any other relevant process documentation (e.g., SOPs, Process Descriptions, etc.)
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
Key Skills, Abilities, and Competencies
- Typically, has a Ph.D. in a relevant scientific discipline (e.g., pharmaceutical sciences, chemical engineering, biological engineering, molecular biology, virology, biochemistry, etc.) with 3-5 years or a B.S./M.S. in a relevant scientific discipline with 6-8 years of relevant scientific and/or technical experience in the life sciences/Biotech field.
- Knowledge or experience of formulation sciences is preferred.
- Adept technical writing skills with experience authoring/reviewing technical documentation (protocols, reports, SOPs, etc.) is preferred.
- Familiarity with gene delivery and/or biomaterials is a plus.
- Strong understanding of the technical and equipment needs in a lab as well as significant hands-on experience with standard molecular and cell biology techniques such as ELISA, qPCR, cell culture, transfection, western blotting, etc. is a plus.
- Familiarity with statistical design/analysis software is a plus.
Complexity and Problem Solving
- Experience and knowledge in upstream cell culture process development.
- Experience and knowledge in general and advanced nanoparticle formulation techniques.
- Experience or knowledge with different characterization methods such as flow cytometry, dynamic light scattering and zeta potential.
- 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.
- Good scientific knowledge of cell and molecular biology, biochemistry, and formulation sciences.
- Capability in experimental design and data analysis, and experience troubleshooting.
- Ability to evaluate, refine, and implement new technology.
- Excellent written and verbal communication skills.
- Planning and organizational skills.
Internal and External Contacts
- 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.
Other Job Requirements
- 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.
- 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.
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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.
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