(Sr.) Scientist, Analytical Development jobs in United States
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ProBio · 1 hour ago

(Sr.) Scientist, Analytical Development

ProBio is a biotechnology company committed to providing end-to-end CDMO services from drug discovery to commercialization. The role of Sr. Scientist, Analytical Development involves supporting the development and optimization of GMP QC-Analytics Lab and leading efforts in technology transfer and CMC activities to enhance manufacturing capabilities for clinical trial materials.

BiopharmaBiotechnologyLife ScienceMedicalPharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Support the set-up, development and optimization of GMP QC-Analytics Lab
Generate and characterize engineered cell lines, including production of MCB and WCB for cell-based assay development
Develop, optimize, and execute molecular and cellular assays to assess vector performance using qPCR/ddPCR based assay, Western blot, ELISA and Flow cytometry
Independently plan, perform, analyze, and interpret experiments, present clear data summaries and recommendations to cross-functional teams and clients
Prepare technical reports, study summaries, and presentation materials to support decision-making
Collaborate closely with other teams in CMC and coordinate cross-functional activities to support tech transfer and CMC activities
Drive continuous improvement by identifying and implementing new tools, technologies, and best practices in CGT CMC analytics
Ensure compliance with BSL-2 biosafety standards, cGMP, and applicable regulatory requirements
May travel up to 10% to support CDMO projects or business development activities

Qualification

Molecular BiologyCell & Gene TherapyGMP ComplianceQPCR/ddPCRELISAWestern BlottingFlow CytometryRegulatory KnowledgeProblem-SolvingCommunication SkillsTeam Collaboration

Required

PHD with 2+ years or M.S. with 3+ years in Molecular Biology, Cell & Gene Therapy, Biochemistry, or related field
Demonstrated hands-on experience in lentiviral vector release testing and characterization (required)
Expertise in molecular and cell biology techniques, including qPCR, ddPCR, ELISA or DNA Sequencing/Analysis
Hands-on experience with Western blotting and flow cytometry for protein and cell-based analyses
Working knowledge of Good Documentation Practices, data integrity, and ALCOA+ principles
Strong problem-solving skills with the ability to work independently and collaboratively in a team environment
Excellent interpersonal, verbal, and written communication skills
Familiarity with regulatory requirements and guidance from agencies such as FDA and ICH; experience with EU Annex 1 and laboratory audits is a plus

Preferred

Exposure to NGS-based methods for vector or genome characterization is a plus
Experience with EU Annex 1 and laboratory audits is a plus

Company

ProBio

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ProBio is a global contract development and manufacturing (CDMO) organization, which aims to accelerate the manufacturing of life-changing drugs, discover novel therapeutic targets, and develop innovative therapeutic approaches to manufacture best-in-class DNA, RNA, and protein-based therapeutics.

H1B Sponsorship

ProBio 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
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (8)

Funding

Current Stage
Growth Stage
Total Funding
$220M
Key Investors
Legend Capital
2023-01-18Series C· $220M

Leadership Team

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Allen Guo
CEO
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Michael Vreeland
US Site Head
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Company data provided by crunchbase