Astellas Pharma · 3 hours ago
Scientist I - Analytical Development
South San Francisco, CA
Full-time
Onsite
Entry Level
$91K/yr - $143K/yr
1+ years expAstellas Pharma is a pharmaceutical company committed to developing innovative therapies for patients. The Scientist I in Analytical Development will independently plan, execute, and transfer assays for GMP release of drug substances and products, collaborating closely with various teams to develop first-in-class Gene Therapy products.
BiotechnologyHealthcareHealth CareMedical
Responsibilities
Develop and transfer assays for the GMP release of gene therapy products according to Target Analytical Profiles, with a deep understanding of our products. Write assay development report and standard operation procedures (SOPs)
Troubleshoot problems that occur during product development, release testing, process development, scale-up or in Manufacturing
Evaluate product testing results and support product formulation and processes
Lead or support product characterization activities for our products
Report project status (development plans, timelines) to supervisor and technical teams
Work collaboratively cross teams and support or author protocol and report for comparability study, report of critical quality attributes risk assessment (CQA-RA)
Collaborate with CMC and research teams to develop first-in-class drugs
Keep current with all regulatory guidelines, compendia requirements, scientific publications, and technical innovations
Attend training sessions and conferences in order to maintain and increase skills and knowledge of GXP’s, safety awareness and scientific knowledge
Follow relevant Operating Procedures
Qualification
Required
PhD with 1+ years, or MS with 5+ years, in Biology with industry experience in biotech/biopharma companies with technical expertise on viruses, proteins, DNA and other macro-biologics using standard methods
Proven expertise with drug development in CMC group
Experience in viral, cell and molecular biological technologies including but not limited to cell-based assay, DNA cloning, PCR, ELISA, Western etc.. Expertise with range of biological methodologies consistent with ICH guidelines for quantifying purity/quality of viruses, proteins or DNA
Success designing experiments, analyzing data and making decisions based on results applied to viral vectors, protein and DNA
Prior history in compiling and analyzing data and generating reports which is routinely presented to project teams to enable decision making and writing for regulatory filings
Experience in technical leading and supervising research associates to perform experiments
Excellent communication and interpersonal skills
A clear and organized thought process, with attention to detail and a high quality work ethic are essential
Strong work ethic with transparency and a passion for working in a fast-paced, dynamic and diverse work environment
Ability to exercise sound judgment, tact, diplomacy, integrity and professionalism in all interactions
Ability to keep current with regulation guideline, compendia requirement, scientific publications and innovative technologies
Proven track record of excellent judgment, problem resolution, teamwork, some budgeting and/or excel skills, decision-making skills, and the ability to work under pressure required
Proficient in MS Office Suite and work related software
Preferred
Experience in writing comparability protocol, setting spec for product release and identification of critical quality attributes
Success in development and transfer of qualified or validated methodologies to QC and manufacturing consistent with project timelines and regulatory expectations
AAV experience
Familiar with viral vector
Cable of statistical analysis using JMP or other tools
Benefits
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Company-paid fleet vehicle for eligible positions
Referral bonus program
Company
Astellas Pharma
Astellas Pharma is a global pharmaceutical research & development company.
10001+ employees
H1B Sponsorship
Astellas Pharma 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 (7)
2024 (4)
2023 (4)
2022 (2)
2021 (3)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
unknownKey Investors
National Institute on Drug Abuse (NIDA)
2020-07-22Grant
2008-10-13IPO
Leadership Team
Amanda Hart
Head, Global Commercial Analytics and Reporting
Recent News
2026-02-13
2026-02-11
2026-02-11
Company data provided by crunchbase