Asahi Kasei Bioprocess America, Inc. · 1 month ago
Associate Director of Process Development, AFD
Fremont, CA
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$150K/yr - $170K/yr
8+ years expBionova Scientific LLC is a rapidly growing biologics CDMO focused on developing and manufacturing recombinant protein products. The Associate Director of Process Development will be responsible for managing analytical activities in support of drug substance and drug product development, ensuring compliance with cGMP requirements, and leading a team of analysts.
BiotechnologyManufacturing
Responsibilities
Oversee and manage a team engaged in AFD and QC transfer activities. Act as an SME for Analytical Development in the support of drug substance and drug product development, including process chemistry and formulation development
Provide technical review of analytical data integrity, method development, and method validation protocols/reports
Represent functional CMC role and participate in cross functional project teams and manage multiple priorities in a fast-paced, dynamic environment and enact quick problem solving to ensure on-time supply of drug to support GLP toxicology studies and IND-enabling activities across a portfolio of programs
Act as primary liaison for analytical testing performed by external contract organizations and review data collected
Ensure that testing methodologies meet phase-appropriate cGMP requirements
Work with internal subject matter experts to author and review analytical test methods, protocols, and development reports
Review method transfer reports/qualification/validation plans and reports by clients
Author analytical CMC modules to support regulatory filings
Develop sensitive and robust analytical test methods to support release testing and characterization of drug products
Lead and guide the junior analysts for daily analytical activities
Qualification
Required
Ph.D. or Master's degree in biochemistry, analytical chemistry, biology or related discipline with 8-10+ years' experience, or BS for 15+ years' experience in an analytical and/or QC laboratories
In-depth hands-on experience and understanding of protein chemistry and industry-standard analytical tools (CE, HPLC/UPLC, Mass Spec, ELISA, qPCR assays, compendial assays, etc.) and troubleshooting
In depth understanding of process development from early to late stage
Demonstrated expertise with analytical method development, phase appropriate method qualification/validation, release and stability testing, product characterization and specification development and justification
Exhibited track record of success in delivering timely execution of CMC activities ranging from non-GMP and IND-enabling material supplies, through GMP clinical trial supplies
Demonstrated knowledge and application of current industry and compendial standards and regulatory authority guidance and expectations, including ICH, FDA, MHRA, and EMA guidelines and USP-NF, Ph. Eur, BP, and JP compendia
Prior experience in early phase and late phase development (both drug substance and drug product)
Excellent organizational skills with the ability to work on multiple projects with varying complexity and timelines
Exhibited strong organizational and critical thinking skills with an attention to detail enabling sound, technically driven decision making
Proven strong interpersonal, organization and problem-solving skills
Benefits
Health Benefits and Program: Bionova offers health benefits at a subsidized rate.
Healthcare, Dental, and Vision insurance
Life Insurance and Disability Program: 100% covered by Bionova.
Retirement Plan (401K) Up to 8% of Employer Match
Paid time off up to two weeks
10 days of Holidays and 5 days of Sick Leave.
Company
Asahi Kasei Bioprocess America, Inc.
As a global partner to the biopharmaceutical industry, Asahi Kasei Bioprocess helps biologics manufacturers safely and efficiently produce medicines that patients can trust, by dependably supplying innovative yet exceptionally reliable bioprocess consumables, equipment and scientific support services.
51-200 employees
H1B Sponsorship
Asahi Kasei Bioprocess America, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (2)
2024 (1)
2023 (1)
2022 (2)
2021 (2)
Funding
Current Stage
Growth StageLeadership Team
Daniel Strauss
Director of R&D
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