Avidity Biosciences, Inc.
Principal Scientist, Biologics Upstream Process Development
Avidity Biosciences, Inc., San Diego, California, United States, 92189
Principal Scientist, Biologics Upstream Process Development
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Principal Scientist, Biologics Upstream Process Development
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Avidity Biosciences, Inc. Overview
We are seeking an experienced and highly motivated Principal Scientist to support Avidity’s growth into a late-stage clinical and commercial manufacturing company. Reporting to the Senior Director of Biologics Development and Manufacturing, this role will focus on upstream process development and manufacturing-related activities. The ideal candidate will bring hands-on expertise in mammalian cell culture (CHO) and primary recovery, with a strong foundation in process development and characterization. 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). Developing and qualifying scale-down models to support process development and characterization. Establishing an internal media and feed platform to enable high-yield CHO processes. Applying Design of Experiments (DoE) to optimize and characterize upstream processes. Producing bench- and pilot-scale material to support downstream development, analytical development, and toxicology studies. Supporting external manufacturing activities, including technology transfer to CDMOs, reviewing development, manufacturing, and validation documents, managing process data and developing tools for analysis, and troubleshooting process-related issues at external sites. Authoring technical reports and presenting findings at departmental and cross-functional meetings. Ensuring 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 is 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, including annual and spot bonuses, stock options, RSUs, and a 401(k) with employer match. Comprehensive wellness program includes medical, dental, vision, and LTD, and four weeks of time off. A commitment to learning and development with internally developed programs, industry training opportunities, 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 Job Function and Industry
Job function: Research, Analyst, and Information Technology Industries: Biotechnology Referrals increase your chances of interviewing at Avidity Biosciences, Inc. by 2x Get notified about new Process Development Scientist jobs in San Diego, CA.
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Join to apply for the
Principal Scientist, Biologics Upstream Process Development
role at
Avidity Biosciences, Inc. Overview
We are seeking an experienced and highly motivated Principal Scientist to support Avidity’s growth into a late-stage clinical and commercial manufacturing company. Reporting to the Senior Director of Biologics Development and Manufacturing, this role will focus on upstream process development and manufacturing-related activities. The ideal candidate will bring hands-on expertise in mammalian cell culture (CHO) and primary recovery, with a strong foundation in process development and characterization. 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). Developing and qualifying scale-down models to support process development and characterization. Establishing an internal media and feed platform to enable high-yield CHO processes. Applying Design of Experiments (DoE) to optimize and characterize upstream processes. Producing bench- and pilot-scale material to support downstream development, analytical development, and toxicology studies. Supporting external manufacturing activities, including technology transfer to CDMOs, reviewing development, manufacturing, and validation documents, managing process data and developing tools for analysis, and troubleshooting process-related issues at external sites. Authoring technical reports and presenting findings at departmental and cross-functional meetings. Ensuring 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 is 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, including annual and spot bonuses, stock options, RSUs, and a 401(k) with employer match. Comprehensive wellness program includes medical, dental, vision, and LTD, and four weeks of time off. A commitment to learning and development with internally developed programs, industry training opportunities, 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 Job Function and Industry
Job function: Research, Analyst, and Information Technology Industries: Biotechnology Referrals increase your chances of interviewing at Avidity Biosciences, Inc. by 2x Get notified about new Process Development Scientist jobs in San Diego, CA.
#J-18808-Ljbffr