BioSpace
Principal Scientist, Biologics Upstream Process Development
BioSpace, San Diego, California, United States, 92189
Overview
Join to apply for the
Principal Scientist, Biologics Upstream Process Development
role at
BioSpace Avidity Biosciences
seeks to profoundly improve people’s lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs™). We are advancing with a focus on upstream process development for mammalian cell culture and manufacturing, driven by a culture that is integrated, collaborative, agile and patient-focused. The role reports to the Senior Director of Biologics Development and Manufacturing and focuses on upstream process development and manufacturing-related activities. What You Will Contribute
This is an on-site position in La Jolla, California. Establish upstream process development capabilities, including: Building laboratory infrastructure (process and analytical equipment, utilities). Recruiting, mentoring, and leading a process development team. Implementing key unit operations (solution prep, shake flask culture, rocking cellbag, stirred-tank bioreactors, centrifugation, depth filtration). Setting up data acquisition and management systems (e.g., ELN templates). Develop and qualify scale-down models to support process development and characterization. Establish an internal media and feed platform to enable high-yield CHO processes. Apply Design of Experiments (DoE) to optimize and characterize upstream processes. Produce bench- and pilot-scale material to support downstream development, analytical development, and toxicology studies. Support external manufacturing activities, including: Technology transfer to CDMOs. Reviewing development, manufacturing, and validation documents. Managing process data and developing tools for analysis. Troubleshooting process-related issues at external sites. Author technical reports and present findings at departmental and cross-functional meetings. Ensure compliance with FDA, EMA, ICH, GMP, and Avidity policies and procedures. What We Seek
Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Bioengineering, or related discipline required; advanced degree strongly preferred. Ph.D. with 3+ years, M.S. with 6+ years, or B.S. with 8+ years of industry experience in upstream process development. Direct experience with mammalian cell culture bioreactors, including at least 2 years of hands-on experience with ambr250™ systems. Strong background in process characterization studies preferred. Knowledge of how upstream processes influence product quality attributes desired. Experience with analytical methods commonly applied to cell culture processes. Proven ability to analyze, interpret, and trend complex process data. Experience working with CDMOs and supporting technology transfer desirable. Strong record of internal and external collaboration. Excellent communication and interpersonal skills, with the ability to drive constructive and timely problem-solving. Ability to manage multiple priorities and thrive in a fast-paced environment. Detail-oriented while maintaining focus on the broader program strategy. Familiarity with programming languages or AI/ML tools to support process analysis a plus. What We Will Provide To You
The base salary range for this role is $175,750 - $198,500. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors. Avidity offers competitive compensation and benefits, which include the opportunity for annual and spot bonuses, stock options, and RSUs, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off. A commitment to learning and development which includes a variety of programming internally developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program. Additional Details
Title: Principal Scientist, Biologics Upstream Process Development Location: San Diego, Onsite Position Type: Full Time / Exempt Department: Process Development – Biologics ID: 7625-Q224-7
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Join to apply for the
Principal Scientist, Biologics Upstream Process Development
role at
BioSpace Avidity Biosciences
seeks to profoundly improve people’s lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs™). We are advancing with a focus on upstream process development for mammalian cell culture and manufacturing, driven by a culture that is integrated, collaborative, agile and patient-focused. The role reports to the Senior Director of Biologics Development and Manufacturing and focuses on upstream process development and manufacturing-related activities. What You Will Contribute
This is an on-site position in La Jolla, California. Establish upstream process development capabilities, including: Building laboratory infrastructure (process and analytical equipment, utilities). Recruiting, mentoring, and leading a process development team. Implementing key unit operations (solution prep, shake flask culture, rocking cellbag, stirred-tank bioreactors, centrifugation, depth filtration). Setting up data acquisition and management systems (e.g., ELN templates). Develop and qualify scale-down models to support process development and characterization. Establish an internal media and feed platform to enable high-yield CHO processes. Apply Design of Experiments (DoE) to optimize and characterize upstream processes. Produce bench- and pilot-scale material to support downstream development, analytical development, and toxicology studies. Support external manufacturing activities, including: Technology transfer to CDMOs. Reviewing development, manufacturing, and validation documents. Managing process data and developing tools for analysis. Troubleshooting process-related issues at external sites. Author technical reports and present findings at departmental and cross-functional meetings. Ensure compliance with FDA, EMA, ICH, GMP, and Avidity policies and procedures. What We Seek
Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Bioengineering, or related discipline required; advanced degree strongly preferred. Ph.D. with 3+ years, M.S. with 6+ years, or B.S. with 8+ years of industry experience in upstream process development. Direct experience with mammalian cell culture bioreactors, including at least 2 years of hands-on experience with ambr250™ systems. Strong background in process characterization studies preferred. Knowledge of how upstream processes influence product quality attributes desired. Experience with analytical methods commonly applied to cell culture processes. Proven ability to analyze, interpret, and trend complex process data. Experience working with CDMOs and supporting technology transfer desirable. Strong record of internal and external collaboration. Excellent communication and interpersonal skills, with the ability to drive constructive and timely problem-solving. Ability to manage multiple priorities and thrive in a fast-paced environment. Detail-oriented while maintaining focus on the broader program strategy. Familiarity with programming languages or AI/ML tools to support process analysis a plus. What We Will Provide To You
The base salary range for this role is $175,750 - $198,500. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors. Avidity offers competitive compensation and benefits, which include the opportunity for annual and spot bonuses, stock options, and RSUs, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off. A commitment to learning and development which includes a variety of programming internally developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program. Additional Details
Title: Principal Scientist, Biologics Upstream Process Development Location: San Diego, Onsite Position Type: Full Time / Exempt Department: Process Development – Biologics ID: 7625-Q224-7
#J-18808-Ljbffr