The Senior Scientist – Upstream Process Development is a key member of the Upstream PD Group. She/he will:
- Design and lead lab execution of upstream process development experiments, including optimization, ranging, and process characterization (PC) while applying Quality by Design principles with focus on shaker flask, rocking bioreactor, and stirred tank bioreactor production at bench and pilot scales.
- Author protocols, reports, process summary documents, risk assessments, control strategy, and process performance qualification (PPQ)/validation documents, as needed, to progress pipeline.
- Participate in Technology Transfer from process development to manufacturing sites; participate in Person-In-Plant support of manufacturing operations; assist in training manufacturing staff, as needed, as technical support of MSAT personnel.
- Execute risk assessments and resource prioritization to balance speed to clinic and product quality/yield/economic considerations to guide phase appropriate process development.
- Author and review CMC (Chemistry Manufacturing Control) filing 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 groups, Lab Operations, and Project Management.
- Support and drive new technology initiatives; implement to improve upstream efficiency
- Troubleshoot bench and pilot scale production processes and/or support investigations; performing support studies as needed.
The Senior Scientist – Process Development Scientist position requires the following:
- The successful candidate will be skilled in early- and late-phase upstream process development, including cell culture operations, rocking- and stirred-tank bioreactor operations and engineering principles.
- She/he should have hands-on experience in bioreactor operations at various scales including ambr15, ambr250, 3-50L, and >100L.
- She/he should have experience in technology transfer (TT) of early and/or late phase products to manufacturing sites. Process validation and Continued Process Validation (CPV) experience is a plus. Previous Person-In-Plant experience is a plus.
- Technical writing experience is required, including process development protocols and reports, as well as process summary/TT documentation; risk assessments and control strategy documentation is a plus; IND and/or BLA filing granule authorship is a plus.
% of Time
Job Function and Description
Design and execute experiments, deliver results for the various development projects. Assemble data sets into reportable and/or presentable formats.
Author technical process development reports and any other relevant process documentation (e.g., TT documentation, SOPs, Process Descriptions, Regulatory filing sections, etc.).
Lead lab operations and coordinate activities for successful study execution including training of less-experienced scientists and troubleshooting, as needed
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.
- Extensive knowledge and experience in upstream process development and operations (cell culture, production bioreactors) is essential.
- Strong understanding of the technical and equipment needs in a lab as well as significant hands-on experience with standard production bioreactor scales (ambr, 3-50L, and >100L) is essential.
- Adept technical writing skills with experience authoring/reviewing technical documentation (protocols, reports, SOPs, etc.) is essential.
- Familiarity with rAAV production is a plus.
- Familiarity with Technology Transfer (TT), process validation, and cGMPs is a plus.
- Familiarity with statistical design/analysis software is a plus.
- Familiarity with downstream process stages and development (dead-end filtration, chromatography, and TFF) is a plus.
Complexity and Problem Solving
- Experience and knowledge in upstream process development including cell culture and production bioreactor operations.
- Experience or knowledge with different in-process and product quality analytical testing techniques.
- 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, execution, and data analysis, and experience troubleshooting.
- Demonstrated ability to train lab-level scientists in variety of tasks include material preparations, bioreactor execution, sample handling and submission, and data aggregation and analysis
- Ability to evaluate, refine, and implement new technology.
- Excellent written and verbal communication and planning/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 environment and interactions 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 experimental designs and data, as well as 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 contract 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.
Nearest Major Market:
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.