- Lead upstream mammalian cell culture process development activities ranging from vial thaw, inoculum, cell culture development, and benchtop bioreactor/stainless steel bioreactor operations.
- Champion and progress select therapeutic candidates from early-stage Phase I to late-stage Phase II and Phase III clinical trials to commercialization.
- Lead technology transfer processes and work cross-functionally between Process Development and Manufacturing departments.
- Work cross-functionally with Downstream Process Development, Analytical Development, Manufacturing, Regulatory, and Quality departments for upstream related process improvement, process validation, process change control, deviation investigation, and process characterization activities.
- Manage laboratory experiments including scale-down studies, validation studies, process range studies, process robustness studies, and manufacturing troubleshooting activities.
- Lead upstream CMC development activities and contribute to IND regulatory submissions.
- Performing such other duties as may be assigned to you from time to time
- Ph.D. or MS in Biochemical Engineering, Chemical Engineering or related Scientific/Engineering field.
- 5+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience.
- Hands-on expertise in engineering and operating shake flasks, small-scale bioreactors, bench-top bioreactors including ambr, pilot scale reactors and stainless-steel bioreactors used for mammalian cell culture processes.
- Collaborate with cross-functional teams to optimize upstream bioprocess parameters, such as pH, temperature, agitation, and aeration to maximize yield, productivity, and product quality to support exosome production.
- Proficiency in data analysis and interpretation using software tools such as DOE, JMP to support process optimization.
- Ability to work independently with minimal supervision and adapt to changing priorities in a fast-paced environment.
- Strong Scientific and Engineering expertise developing novel upstream mammalian cell culture processes for biologic therapeutics (experience with cell therapeutic products and virus-like particles is preferred)
- Experience leading upstream process transfer activities with CMOs.
- Experience with GMP regulatory guidelines as related to the development of cell and gene therapy manufacturing processes is preferable.
- Laboratory environment working with chemical reagents and analytical equipment.
- Personal Protective Equipment must be worn as required.
- Must be able to lift up to 20 lbs.
- Must be able to stand/walk to work in a lab environment for extended periods.
- Must be able to sit for extended periods to use the computer.
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Principal Scientist, Analytical Development
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Analytical Development Scientist
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Meet San Diego, United StatesCompany Overview: · We are a rapidly expanding organization seeking a skilled and accomplished individual to join our team as an Analytical Senior Scientist or Principal Scientist. This role will play a pivotal part in our research and development efforts, focusing on small molec ...
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Viking Therapeutics San Diego, United Statesread more " · Purpose of Role: · This position reports to the Vice President of pharmaceutical development. The associate research associate/scientist will contribute to the ongoing efforts to develop first-in-class or best-in-class therapies for metabolic and endocrine disorders ...
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Sr. Scientist, Sequencing Assay Development
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BioPhase Solutions San Diego, United StatesJob Description · Job DescriptionSummary · This role will be responsible advancing company knowledge of cell and gene therapy sequencing assays through innovative experimental design and efficient execution. The ideal candidate will have a proven track record in successfully deve ...
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Scientist, Analytical Development
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Neurocrine Biosciences Inc. San Diego, United StatesWho We Are: · At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering ...
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Adcentrx Therapeutics San Diego, United StatesPrincipal Scientist/Associate Director Antibody Process Development · We are seeking a Principal Scientist/Associate Director Antibody Process Development to join the Adcentrx CMC team.Adcentrx Therapeutics is driving ground-breaking efforts in cancer biotherapeutics drug develo ...
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Principal Scientist, Analytical Development
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Sr/Principal Scientist, Analytical Development
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Scientist, Cell Therapy Analytical Development
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Turnstone Biologics San Diego, United StatesWe are seeking a highly effective, self-motivated Scientist to join our Analytical Development team at Turnstone Biologics. In this role, you will contribute to the advancement of our cell therapy programs, particularly in developing next-generation T-cell therapies for solid tum ...
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Meet Recruitment San Diego, United StatesMeet's partnered with an exciting and growing biotech in San Diego for a Senior Scientist / Principal Scientist Analytical Development · You'll be responsible for designing, executing, and reporting on the analytical development of small molecule chemistry experiments, degradatio ...
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Viking Therapeutics, Inc. San Diego, United Statesread more " · Purpose of Role: · This position reports to the Vice President of pharmaceutical development. The associate research associate/scientist will contribute to the ongoing efforts to develop first-in-class or best-in-class therapies for metabolic and endocrine disorders ...
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Materials Scientist
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Senior Data Scientist
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tekHouse San Diego, California, United States ContractTitle: Senior Data Scientist · Location: Remote (EST) · Type/ Duration: Contract (12 month+) · Industry: Healthcare · The Senior Data Scientist will be responsible for the development and implementation of predictive modeling algorithms and techniques to solve complex business pr ...
process development scientist - San Diego, United States - Capricor Inc
Description
Job Description
Job DescriptionPosition: Process Development Scientist
We are seeking a highly motivated and creative individual to be a part of a cutting-edge cell and gene therapy process and product development team. The successful candidate will be responsible for leading upstream process development/optimization studies to advance our R&PD programs from pre-clinical to IND filing and ultimately to BLA filing and commercial launch. The candidate will also be responsible for leading upstream technology transfer activities to our internal manufacturing site and CMOs.
Responsibilities:
Requirements:
Work Environment / Physical Demands:
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